Giant Cell Arteritis
Conditions
Keywords
Giant Cell Arteritis, Sirukumab, Prednisone
Brief summary
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable. Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.
Interventions
DRUGSirukumab
Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.
Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.
DRUGPrednisone
Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).
DRUGPlacebo to match prednisone
Placebo to match prednisone will be provided as tablets.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria: Age \>=50 years. History of ESR \>=50 millimeter/hour (mm/hour) or CRP \>=2.45 milligram/deciliter(mg/dL). Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of polymyalgia rheumatic (PMR). Presence of at least one of the following: Temporal artery biopsy revealing features of GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging. * Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined by an ESR \>=30 mm/hr or CRP \>=1 mg/dL AND the presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by the clinician investigator to be consistent with GCA or PMR flares. * At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA. * Clinically stable GCA disease at baseline such that the subject is able to safely participate in the blinded prednisone taper regimen in the opinion of the investigator. * Practicing acceptable methods of birth control if a female of child-bearing potential. * No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
Exclusion criteria
* Are pregnant or breastfeeding. * Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments. * Organ transplantation recipients (except corneas within 3 months prior to baseline visit). * Had prior treatment with any of the following: Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline; Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate use within 2 weeks of baseline. Methylprednisolone \> 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of baseline. * History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients. * Evidence of serious concomitant disease, which in the opinion of the investigator makes them unsuitable for participation in the study. * Major ischemic event, unrelated to GCA, within 12 weeks of screening. * Marked baseline prolongation of corrected QT (QTc) interval \>= 450 milliseconds (msec) (QTc by Bazett's formula \[QTcB \]or QTc by Fridericia's formula \[QTcF\] ), history of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block. * Current liver disease that could interfere with the trial * History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal tract condition that might predispose to bowel perforation. * History of known demyelinating diseases such as multiple sclerosis or optic neuritis. * Active infections, or history of recurrent infections or have required management of acute or chronic infections, as follows: Currently on any suppressive therapy for a chronic infection, history or suspicion of chronic infection, hospitalization for treatment of infection within 60 days of the baseline visit, or use of parenteral (IV) or intra-muscular \[IM\]) antimicrobials within 60 days of baseline or oral antimicrobials within 30 days of baseline * Primary or secondary immunodeficiency or any other autoimmune disease. * Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection * Live virus or bacterial vaccination within 3 months before the first administration of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Number of Participants in Sustained Remission at Week 52 | Week 52 | Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Cumulative Prednisone Dose Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg. |
| Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | Baseline (Week 0), Weeks 12, 24, 36, 52 | SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented. |
| Part B: Number of Participants in Sustained Remission Over Time | Weeks 4, 8 and 12 | Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30millimeters per hour\] and CRP \[\<1milligram/deciliter\]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. |
| Part A: Time to First Disease Flare After Clinical Remission | Week 52 | Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented. |
| Part B: Time to First Disease Flare for Participants in Sustained Remission | Week 52 | Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented. |
| Part A: Number of Disease Flares Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented. |
| Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented. |
| Part A: Number of Hospitalizations for Disease Flare Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented. |
| Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Baseline (Week 0) and Weeks 12, 24, 36, 52 | EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). |
| Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Baseline (Week 0) and Weeks 12, 24, 36, 52 | EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. |
| Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Baseline (Week 0), Weeks 12, 24, 36, 52 | The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items. |
| Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Data for NRS scores over time for part A is reported. |
| Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Baseline (Week 0) and Weeks 12, 24, 36 and 52 | Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability. |
| Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Weeks 12, 24 and 52 | Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. |
| Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). |
| Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (none) to 10 (extremely active). |
| Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP. |
| Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported. |
| Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Up to 52 weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported. |
| Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Pulse Rate | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Temperature | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Hematology Parameter-Hematocrit | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part A: Mean Serum Concentrations of Sirukumab | Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52 | Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points. |
| Part A: Mean Serum Anti-sirukumab Antibodies | Baseline (Week 0) and up to 52 weeks | Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points. |
| Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time | Baseline (Week 0) and up to 52 weeks | Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study. |
| Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Up to 120 weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported. |
| Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | Up to 120 weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported. |
| Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120) | SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120) | SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120) | Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120) | Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented. |
| Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120) | Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120) | Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. |
| Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. |
| Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented |
| Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented. |
| Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Baseline (Week 0) and Weeks 4,8,12,16,24 and 36 | Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38 | Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented. |
| Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38 | Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented. |
| Part B: Number of Disease Flares Over Time | Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented. |
| Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare | Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study. |
| Part B: Number of Hospitalizations for Disease Flare Over Time | Up to Week 104 | Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study. |
| Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24 | SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12 | SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24 | EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12 | EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24 | The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24 | The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported. |
| Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24 | The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24 | The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported. |
| Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Day 87, 339, 344, Week 12, 24 | Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability |
| Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12 | Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability |
| Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344 | The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | Week 24 | Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30 millimeters per hour\] and CRP \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. |
| Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40 | In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373 | In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported. |
| Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 1), Days 103 and 271 | Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. |
| Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 1) | Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category. |
| Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36 | Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40 | Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36 | Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24 | EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12 | EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. |
| Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373 | The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported. |
Countries
Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of sirukumab in treatment of participants with Giant Cell Arteritis (GCA). A total of 161 participants were enrolled.
Pre-assignment details
This study was conducted in 2 distinct parts (Part A and Part B), Part A was a 52-week double-blind treatment phase and Part B was a 104-week long-term extension phase with the option to receive open-label sirukumab (SIR) (up to a 52-week duration of open-label treatment). This study was terminated early by sponsor.
Participants by arm
| Arm | Count |
|---|---|
| SIR100 mg SC q2w+6 Month Prednisone Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen | 42 |
| SIR 100 mg SC q2w+3 Month Prednisone Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen | 39 |
| SIR 50 mg SC q4w+6 Month Prednisone Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen | 26 |
| Placebo SC q2w + 6 Month Prednisone Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen | 27 |
| Placebo SC q2w + 12 Month Prednisone Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen | 27 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A (52 Weeks) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part A (52 Weeks) | Other | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (52 Weeks) | Physician Decision | 1 | 4 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (52 Weeks) | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part A (52 Weeks) | Sponsor request | 24 | 24 | 18 | 18 | 19 | 0 | 0 | 0 | 0 | 0 |
| Part A (52 Weeks) | Withdrawal by Subject | 6 | 6 | 1 | 3 | 3 | 0 | 0 | 0 | 0 | 0 |
| Part B (104 Weeks) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Part B (104 Weeks) | Sponsor request | 0 | 0 | 0 | 0 | 0 | 8 | 5 | 3 | 5 | 4 |
Baseline characteristics
| Characteristic | SIR100 mg SC q2w+6 Month Prednisone | SIR 100 mg SC q2w+3 Month Prednisone | SIR 50 mg SC q4w+6 Month Prednisone | Placebo SC q2w + 6 Month Prednisone | Placebo SC q2w + 12 Month Prednisone | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 70.5 Years STANDARD_DEVIATION 7.25 | 68.1 Years STANDARD_DEVIATION 6.72 | 67.5 Years STANDARD_DEVIATION 9.45 | 71.6 Years STANDARD_DEVIATION 7.1 | 70.7 Years STANDARD_DEVIATION 8.96 | 69.6 Years STANDARD_DEVIATION 7.85 |
| Race/Ethnicity, Customized African American/African Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White: Arabic/North African Heritage | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 41 Participants | 37 Participants | 25 Participants | 26 Participants | 27 Participants | 156 Participants |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 19 Participants | 23 Participants | 21 Participants | 124 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 7 Participants | 4 Participants | 6 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 39 | 0 / 26 | 0 / 27 | 0 / 27 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 2 | 0 / 6 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 2 |
| other Total, other adverse events | 41 / 42 | 36 / 39 | 25 / 26 | 26 / 27 | 24 / 27 | 2 / 2 | 1 / 1 | 1 / 1 | 2 / 2 | 2 / 2 | 4 / 6 | 3 / 4 | 2 / 3 | 1 / 3 | 0 / 2 |
| serious Total, serious adverse events | 8 / 42 | 6 / 39 | 6 / 26 | 5 / 27 | 6 / 27 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 2 | 0 / 6 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Part A: Number of Participants in Sustained Remission at Week 52
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.
Time frame: Week 52
Population: Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least 1 dose of SC investigational product (IP).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants in Sustained Remission at Week 52 | 3 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants in Sustained Remission at Week 52 | 2 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants in Sustained Remission at Week 52 | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants in Sustained Remission at Week 52 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants in Sustained Remission at Week 52 | 0 Participants |
Secondary
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 12,n=32,28,24,22,21 | -19.2 International units per liter | Standard Deviation 15.6 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 8,n=34,31,24,22,23 | -16.8 International units per liter | Standard Deviation 11.61 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 4,n=37,38,25,23,27 | -15.5 International units per liter | Standard Deviation 13.96 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 36,n=15,12,10,12,13 | 8.7 International units per liter | Standard Deviation 13.58 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 32,n=19,15,10,12,13 | 8.8 International units per liter | Standard Deviation 7.63 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 2,n=38,39,26,24,26 | -9.3 International units per liter | Standard Deviation 15.76 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 52,n=9,5,5,5,4 | 1.3 International units per liter | Standard Deviation 5.98 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 48,n=9,8,5,8,5 | 2.3 International units per liter | Standard Deviation 6.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 40,n=15,11,9,10,10 | 5.3 International units per liter | Standard Deviation 8.85 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 8,n=34,31,24,22,23 | 6.0 International units per liter | Standard Deviation 14.7 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 44,n=11,11,6,8,9 | 1.8 International units per liter | Standard Deviation 5.51 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 48,n=9,8,5,8,5 | 8.1 International units per liter | Standard Deviation 4.04 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 28,n=19,18,12,13,14 | 9.0 International units per liter | Standard Deviation 7.23 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 24,n=22,21,16,17,16 | 9.8 International units per liter | Standard Deviation 8.52 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 20,n=25,23,19,18,16 | 14.6 International units per liter | Standard Deviation 27.52 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 12,n=32,28,24,22,21 | 4.7 International units per liter | Standard Deviation 6.91 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 44,n=11,11,6,8,9 | 8.1 International units per liter | Standard Deviation 3.56 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 16,n=28,26,22,19,18 | 8.5 International units per liter | Standard Deviation 8.94 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 12,n=32,28,24,22,21 | 7.6 International units per liter | Standard Deviation 9.02 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 8,n=34,31,24,22,23 | 6.4 International units per liter | Standard Deviation 6.43 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 16,n=28,26,22,19,18 | 4.1 International units per liter | Standard Deviation 8.11 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 4,n=37,38,25,23,27 | 6.6 International units per liter | Standard Deviation 11.17 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 4,n=37,38,25,23,27 | 5.4 International units per liter | Standard Deviation 8.43 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 2,n=38,39,26,24,26 | 6.1 International units per liter | Standard Deviation 8.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 52,n=9,5,5,5,4 | -26.0 International units per liter | Standard Deviation 29.2 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 20,n=25,23,19,18,16 | 16.1 International units per liter | Standard Deviation 51.67 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 2,n=38,39,26,24,26 | 8.2 International units per liter | Standard Deviation 17.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 48,n=9,8,5,8,5 | -24.4 International units per liter | Standard Deviation 28.77 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 44,n=11,11,6,8,9 | -19.4 International units per liter | Standard Deviation 24.3 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 40,n=15,11,9,10,10 | -14.5 International units per liter | Standard Deviation 22.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 24,n=22,21,16,17,16 | 8.3 International units per liter | Standard Deviation 13.62 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 52,n=9,5,5,5,4 | 7.1 International units per liter | Standard Deviation 3.33 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 36,n=15,12,10,12,13 | -20.3 International units per liter | Standard Deviation 24.22 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 32,n=19,15,10,12,13 | -15.9 International units per liter | Standard Deviation 22.94 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 28,n=19,18,12,13,14 | -17.6 International units per liter | Standard Deviation 23.06 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 28,n=19,18,12,13,14 | 6.7 International units per liter | Standard Deviation 8.75 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 40,n=15,11,9,10,10 | 8.9 International units per liter | Standard Deviation 4.56 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 24,n=22,21,16,17,16 | -16.3 International units per liter | Standard Deviation 20.32 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 20,n=25,23,19,18,16 | -14.4 International units per liter | Standard Deviation 21.82 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 16,n=28,26,22,19,18 | -18.2 International units per liter | Standard Deviation 15.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 32,n=19,15,10,12,13 | 6.6 International units per liter | Standard Deviation 11.06 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 36,n=15,12,10,12,13 | 10.6 International units per liter | Standard Deviation 8.85 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 20,n=25,23,19,18,16 | 4.9 International units per liter | Standard Deviation 15.83 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 2,n=38,39,26,24,26 | 5.3 International units per liter | Standard Deviation 14.63 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 4,n=37,38,25,23,27 | 6.6 International units per liter | Standard Deviation 16.09 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 8,n=34,31,24,22,23 | 9.5 International units per liter | Standard Deviation 12.71 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 12,n=32,28,24,22,21 | 4.4 International units per liter | Standard Deviation 10.82 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 16,n=28,26,22,19,18 | 2.2 International units per liter | Standard Deviation 9.86 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 24,n=22,21,16,17,16 | 2.5 International units per liter | Standard Deviation 14.71 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 28,n=19,18,12,13,14 | 2.9 International units per liter | Standard Deviation 14.59 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 32,n=19,15,10,12,13 | 5.0 International units per liter | Standard Deviation 14.05 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 36,n=15,12,10,12,13 | 6.0 International units per liter | Standard Deviation 15.22 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 40,n=15,11,9,10,10 | 7.3 International units per liter | Standard Deviation 19.52 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 44,n=11,11,6,8,9 | 5.5 International units per liter | Standard Deviation 15.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 48,n=9,8,5,8,5 | 4.5 International units per liter | Standard Deviation 16.52 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 52,n=9,5,5,5,4 | 1.6 International units per liter | Standard Deviation 19.63 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 2,n=38,39,26,24,26 | -11.4 International units per liter | Standard Deviation 7.46 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 4,n=37,38,25,23,27 | -13.4 International units per liter | Standard Deviation 12.75 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 8,n=34,31,24,22,23 | -10.4 International units per liter | Standard Deviation 13.73 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 12,n=32,28,24,22,21 | -7.0 International units per liter | Standard Deviation 10.15 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 16,n=28,26,22,19,18 | -8.0 International units per liter | Standard Deviation 12.61 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 20,n=25,23,19,18,16 | -4.4 International units per liter | Standard Deviation 12.89 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 24,n=22,21,16,17,16 | -6.2 International units per liter | Standard Deviation 13.76 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 28,n=19,18,12,13,14 | -4.3 International units per liter | Standard Deviation 14.99 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 32,n=19,15,10,12,13 | -6.1 International units per liter | Standard Deviation 11.89 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 36,n=15,12,10,12,13 | -7.3 International units per liter | Standard Deviation 11.18 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 40,n=15,11,9,10,10 | -7.4 International units per liter | Standard Deviation 10.16 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 44,n=11,11,6,8,9 | -6.2 International units per liter | Standard Deviation 13.48 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 48,n=9,8,5,8,5 | -6.5 International units per liter | Standard Deviation 8.45 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 52,n=9,5,5,5,4 | -8.0 International units per liter | Standard Deviation 9.14 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 2,n=38,39,26,24,26 | 3.7 International units per liter | Standard Deviation 4.81 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 4,n=37,38,25,23,27 | 5.9 International units per liter | Standard Deviation 6.74 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 8,n=34,31,24,22,23 | 10.6 International units per liter | Standard Deviation 8.9 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 12,n=32,28,24,22,21 | 9.0 International units per liter | Standard Deviation 5.64 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 16,n=28,26,22,19,18 | 7.0 International units per liter | Standard Deviation 5.79 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 20,n=25,23,19,18,16 | 7.7 International units per liter | Standard Deviation 7.24 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 24,n=22,21,16,17,16 | 7.6 International units per liter | Standard Deviation 6.75 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 28,n=19,18,12,13,14 | 8.1 International units per liter | Standard Deviation 7.3 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 32,n=19,15,10,12,13 | 9.2 International units per liter | Standard Deviation 7.72 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 36,n=15,12,10,12,13 | 10.8 International units per liter | Standard Deviation 8.09 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 40,n=15,11,9,10,10 | 8.7 International units per liter | Standard Deviation 10.82 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 44,n=11,11,6,8,9 | 9.2 International units per liter | Standard Deviation 8.91 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 48,n=9,8,5,8,5 | 11.8 International units per liter | Standard Deviation 12.63 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 52,n=9,5,5,5,4 | 9.2 International units per liter | Standard Deviation 4.97 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 8,n=34,31,24,22,23 | -15.3 International units per liter | Standard Deviation 7.14 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 44,n=11,11,6,8,9 | -4.0 International units per liter | Standard Deviation 10.86 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 32,n=19,15,10,12,13 | 8.0 International units per liter | Standard Deviation 4.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 20,n=25,23,19,18,16 | 9.0 International units per liter | Standard Deviation 7.46 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 20,n=25,23,19,18,16 | 8.6 International units per liter | Standard Deviation 11.73 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 16,n=28,26,22,19,18 | 8.0 International units per liter | Standard Deviation 7.28 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 48,n=9,8,5,8,5 | -4.4 International units per liter | Standard Deviation 12.82 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 28,n=19,18,12,13,14 | 12.1 International units per liter | Standard Deviation 23.96 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 12,n=32,28,24,22,21 | 4.0 International units per liter | Standard Deviation 6.85 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 12,n=32,28,24,22,21 | 6.5 International units per liter | Standard Deviation 5.24 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 8,n=34,31,24,22,23 | 6.7 International units per liter | Standard Deviation 7.9 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 52,n=9,5,5,5,4 | -3.6 International units per liter | Standard Deviation 7.6 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 4,n=37,38,25,23,27 | -14.2 International units per liter | Standard Deviation 10.17 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 4,n=37,38,25,23,27 | 5.0 International units per liter | Standard Deviation 3.96 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 24,n=22,21,16,17,16 | -12.5 International units per liter | Standard Deviation 9.08 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 52,n=9,5,5,5,4 | 11.6 International units per liter | Standard Deviation 5.68 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 2,n=38,39,26,24,26 | 4.5 International units per liter | Standard Deviation 7.11 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 2,n=38,39,26,24,26 | 10.1 International units per liter | Standard Deviation 23.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 44,n=11,11,6,8,9 | 8.3 International units per liter | Standard Deviation 5.09 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 16,n=28,26,22,19,18 | 5.2 International units per liter | Standard Deviation 10.08 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 36,n=15,12,10,12,13 | 4.5 International units per liter | Standard Deviation 8.44 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 52,n=9,5,5,5,4 | 8.8 International units per liter | Standard Deviation 10.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 48,n=9,8,5,8,5 | 3.6 International units per liter | Standard Deviation 10.48 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 28,n=19,18,12,13,14 | -17.5 International units per liter | Standard Deviation 6.56 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 16,n=28,26,22,19,18 | -14.6 International units per liter | Standard Deviation 8.56 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 44,n=11,11,6,8,9 | 2.7 International units per liter | Standard Deviation 7.09 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 12,n=32,28,24,22,21 | -15.0 International units per liter | Standard Deviation 8.06 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 4,n=37,38,25,23,27 | 5.2 International units per liter | Standard Deviation 6.1 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 32,n=19,15,10,12,13 | -12.6 International units per liter | Standard Deviation 6.93 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 2,n=38,39,26,24,26 | -11.4 International units per liter | Standard Deviation 8.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 40,n=15,11,9,10,10 | 5.4 International units per liter | Standard Deviation 5.61 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 24,n=22,21,16,17,16 | 16.4 International units per liter | Standard Deviation 33.68 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 28,n=19,18,12,13,14 | 9.4 International units per liter | Standard Deviation 10.61 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 36,n=15,12,10,12,13 | -9.6 International units per liter | Standard Deviation 12.51 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 32,n=19,15,10,12,13 | 5.1 International units per liter | Standard Deviation 9.45 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 8,n=34,31,24,22,23 | 4.7 International units per liter | Standard Deviation 8.25 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 24,n=22,21,16,17,16 | 10.5 International units per liter | Standard Deviation 10.02 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 40,n=15,11,9,10,10 | 9.1 International units per liter | Standard Deviation 4.11 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 40,n=15,11,9,10,10 | -9.9 International units per liter | Standard Deviation 11.35 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 36,n=15,12,10,12,13 | 7.6 International units per liter | Standard Deviation 5.02 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 48,n=9,8,5,8,5 | 9.8 International units per liter | Standard Deviation 7.29 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 20,n=25,23,19,18,16 | -13.3 International units per liter | Standard Deviation 9.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 8,n=34,31,24,22,23 | 2.9 International units per liter | Standard Deviation 9.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 4,n=37,38,25,23,27 | -1.2 International units per liter | Standard Deviation 4.2 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 12,n=32,28,24,22,21 | 6.6 International units per liter | Standard Deviation 13.21 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 16,n=28,26,22,19,18 | 1.1 International units per liter | Standard Deviation 12.9 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 28,n=19,18,12,13,14 | -1.9 International units per liter | Standard Deviation 3.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 20,n=25,23,19,18,16 | 5.9 International units per liter | Standard Deviation 19.44 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 36,n=15,12,10,12,13 | 1.3 International units per liter | Standard Deviation 2.56 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 24,n=22,21,16,17,16 | 6.9 International units per liter | Standard Deviation 16.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 28,n=19,18,12,13,14 | 1.6 International units per liter | Standard Deviation 13.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 24,n=22,21,16,17,16 | -2.8 International units per liter | Standard Deviation 6.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 32,n=19,15,10,12,13 | -2.3 International units per liter | Standard Deviation 17 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 36,n=15,12,10,12,13 | -1.8 International units per liter | Standard Deviation 15.49 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 40,n=15,11,9,10,10 | -0.2 International units per liter | Standard Deviation 15.17 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 20,n=25,23,19,18,16 | 2.3 International units per liter | Standard Deviation 22.33 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 40,n=15,11,9,10,10 | 4.7 International units per liter | Standard Deviation 13.17 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 44,n=11,11,6,8,9 | 2.8 International units per liter | Standard Deviation 19.93 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 48,n=9,8,5,8,5 | 1.5 International units per liter | Standard Deviation 18.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 52,n=9,5,5,5,4 | 1.0 International units per liter | Standard Deviation 19.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 16,n=28,26,22,19,18 | -3.5 International units per liter | Standard Deviation 5.23 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 2,n=38,39,26,24,26 | -0.3 International units per liter | Standard Deviation 2.66 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 4,n=37,38,25,23,27 | -1.0 International units per liter | Standard Deviation 2.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 44,n=11,11,6,8,9 | 3.5 International units per liter | Standard Deviation 4.81 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 8,n=34,31,24,22,23 | 0.1 International units per liter | Standard Deviation 2.74 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 12,n=32,28,24,22,21 | -3.3 International units per liter | Standard Deviation 5.39 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 12,n=32,28,24,22,21 | 0.5 International units per liter | Standard Deviation 3.62 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 2,n=38,39,26,24,26 | -0.6 International units per liter | Standard Deviation 3.27 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 16,n=28,26,22,19,18 | 0.2 International units per liter | Standard Deviation 4.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 52,n=9,5,5,5,4 | -0.2 International units per liter | Standard Deviation 3.63 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 20,n=25,23,19,18,16 | 4.3 International units per liter | Standard Deviation 20.22 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 8,n=34,31,24,22,23 | -2.8 International units per liter | Standard Deviation 4.19 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 24,n=22,21,16,17,16 | 0.6 International units per liter | Standard Deviation 4.4 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 48,n=9,8,5,8,5 | 1.3 International units per liter | Standard Deviation 4.68 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 28,n=19,18,12,13,14 | 1.1 International units per liter | Standard Deviation 3.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 40,n=15,11,9,10,10 | 0.1 International units per liter | Standard Deviation 11.82 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 44,n=11,11,6,8,9 | -0.4 International units per liter | Standard Deviation 7.15 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 48,n=9,8,5,8,5 | -3.5 International units per liter | Standard Deviation 3.12 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 36,n=15,12,10,12,13 | -2.8 International units per liter | Standard Deviation 2.77 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 52,n=9,5,5,5,4 | -4.4 International units per liter | Standard Deviation 1.52 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 2,n=38,39,26,24,26 | -3.0 International units per liter | Standard Deviation 5.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 32,n=19,15,10,12,13 | 0.6 International units per liter | Standard Deviation 3.65 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 4,n=37,38,25,23,27 | -2.2 International units per liter | Standard Deviation 8.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 32,n=19,15,10,12,13 | -2.0 International units per liter | Standard Deviation 4.45 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 24,n=22,21,16,17,16 | -1.8 International units per liter | Standard Deviation 20.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 20,n=25,23,19,18,16 | 1.4 International units per liter | Standard Deviation 12.1 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 20,n=25,23,19,18,16 | -1.0 International units per liter | Standard Deviation 12.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 40,n=15,11,9,10,10 | 12.3 International units per liter | Standard Deviation 24.69 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 20,n=25,23,19,18,16 | -8.1 International units per liter | Standard Deviation 14.38 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 16,n=28,26,22,19,18 | -0.3 International units per liter | Standard Deviation 14.43 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 24,n=22,21,16,17,16 | -1.3 International units per liter | Standard Deviation 8.29 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 36,n=15,12,10,12,13 | 7.3 International units per liter | Standard Deviation 20.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 8,n=34,31,24,22,23 | 1.6 International units per liter | Standard Deviation 33.37 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 52,n=9,5,5,5,4 | 4.3 International units per liter | Standard Deviation 6.85 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 2,n=38,39,26,24,26 | -2.6 International units per liter | Standard Deviation 5.81 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 32,n=19,15,10,12,13 | -10.0 International units per liter | Standard Deviation 12.4 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 40,n=15,11,9,10,10 | -2.1 International units per liter | Standard Deviation 6.77 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 32,n=19,15,10,12,13 | 5.2 International units per liter | Standard Deviation 18.44 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 28,n=19,18,12,13,14 | -0.1 International units per liter | Standard Deviation 9.01 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 28,n=19,18,12,13,14 | 2.9 International units per liter | Standard Deviation 19.72 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 32,n=19,15,10,12,13 | 1.2 International units per liter | Standard Deviation 9.49 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 44,n=11,11,6,8,9 | -7.0 International units per liter | Standard Deviation 4.42 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 36,n=15,12,10,12,13 | -10.0 International units per liter | Standard Deviation 13.87 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 4,n=37,38,25,23,27 | -3.1 International units per liter | Standard Deviation 9.8 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 2,n=38,39,26,24,26 | 0.4 International units per liter | Standard Deviation 6.18 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 52,n=9,5,5,5,4 | -1.5 International units per liter | Standard Deviation 11 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 36,n=15,12,10,12,13 | 0.2 International units per liter | Standard Deviation 9.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 4,n=37,38,25,23,27 | -0.7 International units per liter | Standard Deviation 7.1 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 12,n=32,28,24,22,21 | -7.0 International units per liter | Standard Deviation 11.88 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 28,n=19,18,12,13,14 | -8.9 International units per liter | Standard Deviation 12.65 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 2,n=38,39,26,24,26 | 1.8 International units per liter | Standard Deviation 15.16 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 48,n=9,8,5,8,5 | 0.2 International units per liter | Standard Deviation 11.5 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 8,n=34,31,24,22,23 | -1.6 International units per liter | Standard Deviation 7.72 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 12,n=32,28,24,22,21 | -5.3 International units per liter | Standard Deviation 16.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 44,n=11,11,6,8,9 | 2.3 International units per liter | Standard Deviation 3.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 16,n=28,26,22,19,18 | -6.6 International units per liter | Standard Deviation 14.22 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 48,n=9,8,5,8,5 | 6.4 International units per liter | Standard Deviation 5.59 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 12,n=32,28,24,22,21 | 0.1 International units per liter | Standard Deviation 8.74 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 48,n=9,8,5,8,5 | 7.2 International units per liter | Standard Deviation 17.06 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 24,n=22,21,16,17,16 | -9.4 International units per liter | Standard Deviation 13.61 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 40,n=15,11,9,10,10 | 6.7 International units per liter | Standard Deviation 11.36 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 4,n=37,38,25,23,27 | 5.3 International units per liter | Standard Deviation 27.51 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | AST,Week 16,n=28,26,22,19,18 | 1.0 International units per liter | Standard Deviation 11.88 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 8,n=34,31,24,22,23 | -6.8 International units per liter | Standard Deviation 12.81 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALT,Week 52,n=9,5,5,5,4 | 5.3 International units per liter | Standard Deviation 20.81 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | ALP,Week 44,n=11,11,6,8,9 | 11.9 International units per liter | Standard Deviation 24.93 |
Secondary
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 24,n=22,21,16,17,16 | 1.6 Grams per liter | Standard Deviation 2.77 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 36,n=15,12,10,12,13 | -0.3 Grams per liter | Standard Deviation 3.48 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 28,n=19,18,12,13,14 | -2.4 Grams per liter | Standard Deviation 3.3 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 4,n=37,38,25,23,27 | 0.9 Grams per liter | Standard Deviation 2.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 32,n=19,15,10,12,13 | -1.4 Grams per liter | Standard Deviation 3.52 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 20,n=25,23,19,18,16 | 1.8 Grams per liter | Standard Deviation 2.46 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 16,n=28,26,22,19,18 | 1.7 Grams per liter | Standard Deviation 2.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 24,n=22,21,16,17,16 | -1.1 Grams per liter | Standard Deviation 3.64 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 8,n=34,31,24,22,23 | 1.9 Grams per liter | Standard Deviation 2.76 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 16,n=28,26,22,19,18 | -2.3 Grams per liter | Standard Deviation 3.43 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 12,n=32,28,24,22,21 | 2.0 Grams per liter | Standard Deviation 2.26 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 40,n=15,11,9,10,10 | -0.5 Grams per liter | Standard Deviation 3.38 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 2,n=38,39,26,24,26 | -2.6 Grams per liter | Standard Deviation 3.68 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 44,n=11,11,6,8,9 | 3.2 Grams per liter | Standard Deviation 2.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 36,n=15,12,10,12,13 | 3.1 Grams per liter | Standard Deviation 2.61 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 32,n=19,15,10,12,13 | 2.2 Grams per liter | Standard Deviation 2.03 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 48,n=9,8,5,8,5 | 0.3 Grams per liter | Standard Deviation 4.69 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 4,n=37,38,25,23,27 | -2.5 Grams per liter | Standard Deviation 3.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 12,n=32,28,24,22,21 | -1.7 Grams per liter | Standard Deviation 3.19 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 44,n=11,11,6,8,9 | 0.3 Grams per liter | Standard Deviation 2.65 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 28,n=19,18,12,13,14 | 1.5 Grams per liter | Standard Deviation 1.61 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 8,n=34,31,24,22,23 | -1.9 Grams per liter | Standard Deviation 3.53 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 20,n=25,23,19,18,16 | -1.9 Grams per liter | Standard Deviation 3.44 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 52,n=9,5,5,5,4 | -0.4 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 52,n=9,5,5,5,4 | 3.7 Grams per liter | Standard Deviation 2.45 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 48,n=9,8,5,8,5 | 3.4 Grams per liter | Standard Deviation 2.13 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 2,n=38,39,26,24,26 | 0.3 Grams per liter | Standard Deviation 2.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 40,n=15,11,9,10,10 | 3.2 Grams per liter | Standard Deviation 1.97 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 48,n=9,8,5,8,5 | -0.1 Grams per liter | Standard Deviation 3.76 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 12,n=32,28,24,22,21 | -1.3 Grams per liter | Standard Deviation 3.72 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 48,n=9,8,5,8,5 | 4.4 Grams per liter | Standard Deviation 3.2 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 52,n=9,5,5,5,4 | 5.2 Grams per liter | Standard Deviation 1.64 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 2,n=38,39,26,24,26 | -2.4 Grams per liter | Standard Deviation 3.13 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 8,n=34,31,24,22,23 | -1.6 Grams per liter | Standard Deviation 4.16 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 4,n=37,38,25,23,27 | -2.4 Grams per liter | Standard Deviation 4.39 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 52,n=9,5,5,5,4 | 1.0 Grams per liter | Standard Deviation 4.69 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 28,n=19,18,12,13,14 | -0.8 Grams per liter | Standard Deviation 5.27 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 2,n=38,39,26,24,26 | 0.9 Grams per liter | Standard Deviation 1.79 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 4,n=37,38,25,23,27 | 2.0 Grams per liter | Standard Deviation 2.84 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 8,n=34,31,24,22,23 | 3.1 Grams per liter | Standard Deviation 2.35 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 24,n=22,21,16,17,16 | -0.9 Grams per liter | Standard Deviation 4.39 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 12,n=32,28,24,22,21 | 3.4 Grams per liter | Standard Deviation 2.5 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 40,n=15,11,9,10,10 | -1.5 Grams per liter | Standard Deviation 4.93 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 16,n=28,26,22,19,18 | 2.8 Grams per liter | Standard Deviation 2.52 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 20,n=25,23,19,18,16 | 3.9 Grams per liter | Standard Deviation 2.68 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 20,n=25,23,19,18,16 | -0.4 Grams per liter | Standard Deviation 4.69 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 24,n=22,21,16,17,16 | 3.8 Grams per liter | Standard Deviation 2.36 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 32,n=19,15,10,12,13 | -1.5 Grams per liter | Standard Deviation 4.67 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 28,n=19,18,12,13,14 | 3.5 Grams per liter | Standard Deviation 3.38 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 32,n=19,15,10,12,13 | 3.6 Grams per liter | Standard Deviation 3.68 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 44,n=11,11,6,8,9 | -0.4 Grams per liter | Standard Deviation 4.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 16,n=28,26,22,19,18 | -2.0 Grams per liter | Standard Deviation 3.67 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 36,n=15,12,10,12,13 | 4.3 Grams per liter | Standard Deviation 3.75 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 40,n=15,11,9,10,10 | 3.9 Grams per liter | Standard Deviation 3.78 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 36,n=15,12,10,12,13 | -0.8 Grams per liter | Standard Deviation 4.69 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 44,n=11,11,6,8,9 | 4.1 Grams per liter | Standard Deviation 3.36 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 2,n=38,39,26,24,26 | 0.8 Grams per liter | Standard Deviation 1.88 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 44,n=11,11,6,8,9 | -2.0 Grams per liter | Standard Deviation 3.52 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 24,n=22,21,16,17,16 | 3.7 Grams per liter | Standard Deviation 1.85 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 8,n=34,31,24,22,23 | -2.2 Grams per liter | Standard Deviation 3.67 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 28,n=19,18,12,13,14 | -2.7 Grams per liter | Standard Deviation 2.67 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 36,n=15,12,10,12,13 | -0.5 Grams per liter | Standard Deviation 2.51 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 52,n=9,5,5,5,4 | 4.0 Grams per liter | Standard Deviation 2.55 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 28,n=19,18,12,13,14 | 2.4 Grams per liter | Standard Deviation 2.78 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 4,n=37,38,25,23,27 | -1.8 Grams per liter | Standard Deviation 2.81 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 16,n=28,26,22,19,18 | -1.9 Grams per liter | Standard Deviation 3.7 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 48,n=9,8,5,8,5 | -1.8 Grams per liter | Standard Deviation 4.49 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 48,n=9,8,5,8,5 | 1.6 Grams per liter | Standard Deviation 2.7 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 32,n=19,15,10,12,13 | 2.2 Grams per liter | Standard Deviation 2.66 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 8,n=34,31,24,22,23 | 2.1 Grams per liter | Standard Deviation 1.85 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 40,n=15,11,9,10,10 | 2.4 Grams per liter | Standard Deviation 2.07 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 12,n=32,28,24,22,21 | 3.1 Grams per liter | Standard Deviation 1.54 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 44,n=11,11,6,8,9 | 2.2 Grams per liter | Standard Deviation 2.23 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 24,n=22,21,16,17,16 | 0.0 Grams per liter | Standard Deviation 2.85 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 32,n=19,15,10,12,13 | -2.1 Grams per liter | Standard Deviation 4.07 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 2,n=38,39,26,24,26 | -1.9 Grams per liter | Standard Deviation 2.73 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 16,n=28,26,22,19,18 | 2.8 Grams per liter | Standard Deviation 2.44 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 40,n=15,11,9,10,10 | -2.1 Grams per liter | Standard Deviation 1.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 20,n=25,23,19,18,16 | -1.3 Grams per liter | Standard Deviation 2.84 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 4,n=37,38,25,23,27 | 1.6 Grams per liter | Standard Deviation 1.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 12,n=32,28,24,22,21 | -0.8 Grams per liter | Standard Deviation 3.06 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 20,n=25,23,19,18,16 | 2.8 Grams per liter | Standard Deviation 2.15 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 52,n=9,5,5,5,4 | 0.6 Grams per liter | Standard Deviation 4.88 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 36,n=15,12,10,12,13 | 2.9 Grams per liter | Standard Deviation 2.08 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 32,n=19,15,10,12,13 | -0.3 Grams per liter | Standard Deviation 4.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 52,n=9,5,5,5,4 | -1.0 Grams per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 36,n=15,12,10,12,13 | -0.3 Grams per liter | Standard Deviation 4.11 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 40,n=15,11,9,10,10 | -0.4 Grams per liter | Standard Deviation 3.27 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 44,n=11,11,6,8,9 | 2.3 Grams per liter | Standard Deviation 5.5 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 48,n=9,8,5,8,5 | 1.4 Grams per liter | Standard Deviation 4.98 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 2,n=38,39,26,24,26 | -0.9 Grams per liter | Standard Deviation 2.64 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 4,n=37,38,25,23,27 | -1.4 Grams per liter | Standard Deviation 2.46 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 8,n=34,31,24,22,23 | -1.1 Grams per liter | Standard Deviation 2.35 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 12,n=32,28,24,22,21 | -0.5 Grams per liter | Standard Deviation 2.81 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 16,n=28,26,22,19,18 | -1.2 Grams per liter | Standard Deviation 2.41 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 20,n=25,23,19,18,16 | -0.9 Grams per liter | Standard Deviation 2.7 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 24,n=22,21,16,17,16 | 0.0 Grams per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 28,n=19,18,12,13,14 | -0.5 Grams per liter | Standard Deviation 2.82 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 32,n=19,15,10,12,13 | -0.7 Grams per liter | Standard Deviation 3.2 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 36,n=15,12,10,12,13 | -1.3 Grams per liter | Standard Deviation 3.25 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 40,n=15,11,9,10,10 | -1.1 Grams per liter | Standard Deviation 2.96 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 44,n=11,11,6,8,9 | 0.4 Grams per liter | Standard Deviation 3.07 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 48,n=9,8,5,8,5 | -0.8 Grams per liter | Standard Deviation 3.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 52,n=9,5,5,5,4 | -1.2 Grams per liter | Standard Deviation 0.84 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 2,n=38,39,26,24,26 | -1.7 Grams per liter | Standard Deviation 3.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 4,n=37,38,25,23,27 | -2.0 Grams per liter | Standard Deviation 3.64 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 8,n=34,31,24,22,23 | -0.7 Grams per liter | Standard Deviation 3.1 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 12,n=32,28,24,22,21 | 1.0 Grams per liter | Standard Deviation 3.68 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 16,n=28,26,22,19,18 | 0.2 Grams per liter | Standard Deviation 3.2 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 20,n=25,23,19,18,16 | 0.6 Grams per liter | Standard Deviation 3.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 24,n=22,21,16,17,16 | 1.5 Grams per liter | Standard Deviation 4.86 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 28,n=19,18,12,13,14 | -0.2 Grams per liter | Standard Deviation 4.39 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 44,n=11,11,6,8,9 | 0.6 Grams per liter | Standard Deviation 2.19 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 40,n=15,11,9,10,10 | -0.5 Grams per liter | Standard Deviation 2.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 28,n=19,18,12,13,14 | 1.6 Grams per liter | Standard Deviation 4.2 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 12,n=32,28,24,22,21 | 0.9 Grams per liter | Standard Deviation 3.67 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 36,n=15,12,10,12,13 | 0.2 Grams per liter | Standard Deviation 3.02 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 32,n=19,15,10,12,13 | 1.1 Grams per liter | Standard Deviation 2.93 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 28,n=19,18,12,13,14 | 0.4 Grams per liter | Standard Deviation 2.98 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 44,n=11,11,6,8,9 | 1.7 Grams per liter | Standard Deviation 2.6 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 16,n=28,26,22,19,18 | 1.0 Grams per liter | Standard Deviation 3.68 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 24,n=22,21,16,17,16 | 0.3 Grams per liter | Standard Deviation 1.88 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 20,n=25,23,19,18,16 | 0.3 Grams per liter | Standard Deviation 2.11 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 16,n=28,26,22,19,18 | 0.6 Grams per liter | Standard Deviation 2.48 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 40,n=15,11,9,10,10 | 1.4 Grams per liter | Standard Deviation 3.03 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 20,n=25,23,19,18,16 | 0.4 Grams per liter | Standard Deviation 2.63 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 12,n=32,28,24,22,21 | 0.2 Grams per liter | Standard Deviation 1.87 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 8,n=34,31,24,22,23 | -0.6 Grams per liter | Standard Deviation 1.8 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 4,n=37,38,25,23,27 | -0.9 Grams per liter | Standard Deviation 2.46 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 36,n=15,12,10,12,13 | 1.8 Grams per liter | Standard Deviation 3.51 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 24,n=22,21,16,17,16 | 0.8 Grams per liter | Standard Deviation 3.09 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 2,n=38,39,26,24,26 | -0.7 Grams per liter | Standard Deviation 2.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 52,n=9,5,5,5,4 | 1.8 Grams per liter | Standard Deviation 4.43 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 48,n=9,8,5,8,5 | 3.2 Grams per liter | Standard Deviation 2.28 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 4,n=37,38,25,23,27 | -2.0 Grams per liter | Standard Deviation 4.05 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 2,n=38,39,26,24,26 | -1.7 Grams per liter | Standard Deviation 3.16 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 52,n=9,5,5,5,4 | 1.5 Grams per liter | Standard Deviation 4.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 32,n=19,15,10,12,13 | 2.6 Grams per liter | Standard Deviation 3.78 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein,Week 8,n=34,31,24,22,23 | -0.7 Grams per liter | Standard Deviation 3.3 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin,Week 48,n=9,8,5,8,5 | 2.0 Grams per liter | Standard Deviation 2.92 |
Secondary
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 2,n=38,39,26,24,26 | 0.1 Micromoles per liter | Standard Deviation 1.03 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 2,n=38,39,26,24,26 | 1.8 Micromoles per liter | Standard Deviation 2.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 4,n=37,38,25,23,27 | 2.4 Micromoles per liter | Standard Deviation 5.05 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 8,n=34,31,24,22,23 | 3.0 Micromoles per liter | Standard Deviation 3.58 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 12,n=32,28,24,22,21 | 4.3 Micromoles per liter | Standard Deviation 8.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 16,n=28,26,22,19,18 | 2.7 Micromoles per liter | Standard Deviation 4.68 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 20,n=25,23,19,18,16 | 4.7 Micromoles per liter | Standard Deviation 9.09 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 24,n=22,21,16,17,16 | 4.9 Micromoles per liter | Standard Deviation 6.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 28,n=19,18,12,13,14 | 4.4 Micromoles per liter | Standard Deviation 5.86 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 32,n=19,15,10,12,13 | 4.2 Micromoles per liter | Standard Deviation 4.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 36,n=15,12,10,12,13 | 5.2 Micromoles per liter | Standard Deviation 4.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 40,n=15,11,6,10,10 | 5.1 Micromoles per liter | Standard Deviation 4.18 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 44,n=11,11,6,8,9 | 4.4 Micromoles per liter | Standard Deviation 6.14 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 48,n=9,8,5,8,5 | 6.7 Micromoles per liter | Standard Deviation 6.22 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 52,n=9,5,5,5,4 | 4.8 Micromoles per liter | Standard Deviation 5.09 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 4,n=37,38,25,23,27 | 0.3 Micromoles per liter | Standard Deviation 0.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 8,n=34,31,24,22,23 | 0.2 Micromoles per liter | Standard Deviation 1.01 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 12,n=32,28,24,22,21 | 0.3 Micromoles per liter | Standard Deviation 1.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 16,n=28,26,22,19,18 | 0.3 Micromoles per liter | Standard Deviation 1.19 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 20,n=25,23,19,18,16 | 1.4 Micromoles per liter | Standard Deviation 3.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 24,n=22,21,16,17,16 | 1.0 Micromoles per liter | Standard Deviation 1.59 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 28,n=19,18,12,13,14 | 0.7 Micromoles per liter | Standard Deviation 1.34 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 32,n=19,15,10,12,13 | 0.5 Micromoles per liter | Standard Deviation 1.26 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 36,n=15,12,10,12,13 | 0.7 Micromoles per liter | Standard Deviation 1.22 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 40,n=15,11,6,10,10 | 0.6 Micromoles per liter | Standard Deviation 1.18 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 44,n=11,11,6,8,9 | 0.8 Micromoles per liter | Standard Deviation 0.98 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 48,n=9,8,5,8,5 | 1.2 Micromoles per liter | Standard Deviation 0.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 52,n=9,5,5,5,4 | 1.0 Micromoles per liter | Standard Deviation 1 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 2,n=38,39,26,24,26 | 1.7 Micromoles per liter | Standard Deviation 2.51 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 4,n=37,38,25,23,27 | 2.1 Micromoles per liter | Standard Deviation 4.93 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 8,n=34,31,24,22,23 | 2.8 Micromoles per liter | Standard Deviation 3.37 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 12,n=32,28,24,22,21 | 4.0 Micromoles per liter | Standard Deviation 7.94 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 16,n=28,26,22,19,18 | 2.4 Micromoles per liter | Standard Deviation 4.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 20,n=25,23,19,18,16 | 3.3 Micromoles per liter | Standard Deviation 6.22 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 24,n=22,21,16,17,16 | 4.0 Micromoles per liter | Standard Deviation 5.52 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 28,n=19,18,12,13,14 | 3.7 Micromoles per liter | Standard Deviation 5.05 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 32,n=19,15,10,12,13 | 3.7 Micromoles per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 36,n=15,12,10,12,13 | 4.5 Micromoles per liter | Standard Deviation 4.02 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 40,n=15,11,6,10,10 | 4.5 Micromoles per liter | Standard Deviation 3.94 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 44,n=11,11,6,8,9 | 3.5 Micromoles per liter | Standard Deviation 5.43 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 48,n=9,8,5,8,5 | 5.4 Micromoles per liter | Standard Deviation 5.68 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 52,n=9,5,5,5,4 | 3.8 Micromoles per liter | Standard Deviation 4.52 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 2,n=38,39,26,24,26 | 4.96 Micromoles per liter | Standard Deviation 9.319 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 4,n=37,38,25,23,27 | 4.00 Micromoles per liter | Standard Deviation 11.061 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 8,n=34,31,24,22,23 | 3.26 Micromoles per liter | Standard Deviation 10.522 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 12,n=32,28,24,22,21 | 2.88 Micromoles per liter | Standard Deviation 11.59 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 16,n=28,26,22,19,18 | 3.87 Micromoles per liter | Standard Deviation 9.387 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 20,n=25,23,19,18,16 | -0.87 Micromoles per liter | Standard Deviation 8.652 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 24,n=22,21,16,17,16 | 1.58 Micromoles per liter | Standard Deviation 9.671 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 28,n=19,18,12,13,14 | 5.00 Micromoles per liter | Standard Deviation 12.803 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 32,n=19,15,10,12,13 | 3.88 Micromoles per liter | Standard Deviation 11.182 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 36,n=15,12,10,12,13 | 1.09 Micromoles per liter | Standard Deviation 11.33 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 40,n=15,11,6,10,10 | 4.87 Micromoles per liter | Standard Deviation 11.617 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 44,n=11,11,6,8,9 | 0.03 Micromoles per liter | Standard Deviation 14.182 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 48,n=9,8,5,8,5 | 7.21 Micromoles per liter | Standard Deviation 14.144 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 52,n=9,5,5,5,4 | 3.56 Micromoles per liter | Standard Deviation 6.903 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 2,n=38,39,26,24,26 | -0.1 Micromoles per liter | Standard Deviation 0.92 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 28,n=19,18,12,13,14 | 3.8 Micromoles per liter | Standard Deviation 3.42 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 24,n=22,21,16,17,16 | 3.0 Micromoles per liter | Standard Deviation 3.88 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 48,n=9,8,5,8,5 | 3.8 Micromoles per liter | Standard Deviation 3.62 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 36,n=15,12,10,12,13 | 0.3 Micromoles per liter | Standard Deviation 1.44 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 44,n=11,11,6,8,9 | 1.8 Micromoles per liter | Standard Deviation 3.52 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 20,n=25,23,19,18,16 | 4.2 Micromoles per liter | Standard Deviation 3.66 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 16,n=28,26,22,19,18 | 4.0 Micromoles per liter | Standard Deviation 3.88 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 36,n=15,12,10,12,13 | -3.82 Micromoles per liter | Standard Deviation 22.27 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 40,n=15,11,6,10,10 | -0.4 Micromoles per liter | Standard Deviation 0.81 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 20,n=25,23,19,18,16 | 4.3 Micromoles per liter | Standard Deviation 4.36 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 12,n=32,28,24,22,21 | 2.7 Micromoles per liter | Standard Deviation 3.28 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 8,n=34,31,24,22,23 | 2.7 Micromoles per liter | Standard Deviation 4.37 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 4,n=37,38,25,23,27 | 1.9 Micromoles per liter | Standard Deviation 2.86 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 44,n=11,11,6,8,9 | -0.4 Micromoles per liter | Standard Deviation 0.81 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 16,n=28,26,22,19,18 | 4.4 Micromoles per liter | Standard Deviation 4.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 2,n=38,39,26,24,26 | 1.6 Micromoles per liter | Standard Deviation 2.84 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 52,n=9,5,5,5,4 | -0.8 Micromoles per liter | Standard Deviation 1.1 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 32,n=19,15,10,12,13 | -2.52 Micromoles per liter | Standard Deviation 20.459 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 48,n=9,8,5,8,5 | -0.3 Micromoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 4,n=37,38,25,23,27 | 0.1 Micromoles per liter | Standard Deviation 0.73 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 40,n=15,11,6,10,10 | 2.9 Micromoles per liter | Standard Deviation 4.13 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 12,n=32,28,24,22,21 | 2.8 Micromoles per liter | Standard Deviation 3.58 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 8,n=34,31,24,22,23 | 2.8 Micromoles per liter | Standard Deviation 4.81 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 48,n=9,8,5,8,5 | -7.15 Micromoles per liter | Standard Deviation 26.68 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 8,n=34,31,24,22,23 | 0.1 Micromoles per liter | Standard Deviation 0.72 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 36,n=15,12,10,12,13 | 5.3 Micromoles per liter | Standard Deviation 5.42 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 4,n=37,38,25,23,27 | 1.9 Micromoles per liter | Standard Deviation 3.1 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 12,n=32,28,24,22,21 | -0.84 Micromoles per liter | Standard Deviation 16.78 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 24,n=22,21,16,17,16 | -0.45 Micromoles per liter | Standard Deviation 20.542 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 12,n=32,28,24,22,21 | 0.1 Micromoles per liter | Standard Deviation 0.66 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 32,n=19,15,10,12,13 | 4.0 Micromoles per liter | Standard Deviation 4.54 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 2,n=38,39,26,24,26 | 1.5 Micromoles per liter | Standard Deviation 3.12 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 8,n=34,31,24,22,23 | 1.48 Micromoles per liter | Standard Deviation 14.285 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 52,n=9,5,5,5,4 | 1.6 Micromoles per liter | Standard Deviation 3.58 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 16,n=28,26,22,19,18 | 0.4 Micromoles per liter | Standard Deviation 0.98 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 20,n=25,23,19,18,16 | 0.33 Micromoles per liter | Standard Deviation 9.278 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 4,n=37,38,25,23,27 | 3.03 Micromoles per liter | Standard Deviation 12.685 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 2,n=38,39,26,24,26 | 4.10 Micromoles per liter | Standard Deviation 12.03 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 44,n=11,11,6,8,9 | -7.06 Micromoles per liter | Standard Deviation 19.793 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 20,n=25,23,19,18,16 | 0.1 Micromoles per liter | Standard Deviation 1.12 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 28,n=19,18,12,13,14 | 3.7 Micromoles per liter | Standard Deviation 3.77 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 52,n=9,5,5,5,4 | 2.4 Micromoles per liter | Standard Deviation 2.61 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 48,n=9,8,5,8,5 | 4.0 Micromoles per liter | Standard Deviation 3.21 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 44,n=11,11,6,8,9 | 2.2 Micromoles per liter | Standard Deviation 3.03 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 24,n=22,21,16,17,16 | 0.0 Micromoles per liter | Standard Deviation 0.89 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 24,n=22,21,16,17,16 | 3.0 Micromoles per liter | Standard Deviation 4.41 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 40,n=15,11,6,10,10 | 3.3 Micromoles per liter | Standard Deviation 3.61 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 36,n=15,12,10,12,13 | 5.0 Micromoles per liter | Standard Deviation 4.47 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 40,n=15,11,6,10,10 | -1.45 Micromoles per liter | Standard Deviation 10.674 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 28,n=19,18,12,13,14 | -0.1 Micromoles per liter | Standard Deviation 1.08 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 16,n=28,26,22,19,18 | 1.16 Micromoles per liter | Standard Deviation 12.971 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 32,n=19,15,10,12,13 | 3.7 Micromoles per liter | Standard Deviation 3.77 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 52,n=9,5,5,5,4 | -5.10 Micromoles per liter | Standard Deviation 30.563 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 28,n=19,18,12,13,14 | 0.46 Micromoles per liter | Standard Deviation 17.574 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 32,n=19,15,10,12,13 | 0.3 Micromoles per liter | Standard Deviation 1.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 20,n=25,23,19,18,16 | 3.6 Micromoles per liter | Standard Deviation 3.58 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 44,n=11,11,6,8,9 | 2.5 Micromoles per liter | Standard Deviation 2.17 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 20,n=25,23,19,18,16 | -0.09 Micromoles per liter | Standard Deviation 5.721 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 48,n=9,8,5,8,5 | 2.2 Micromoles per liter | Standard Deviation 1.79 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 52,n=9,5,5,5,4 | 5.0 Micromoles per liter | Standard Deviation 4.36 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 2,n=38,39,26,24,26 | 0.1 Micromoles per liter | Standard Deviation 0.82 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 4,n=37,38,25,23,27 | 0.1 Micromoles per liter | Standard Deviation 0.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 48,n=9,8,5,8,5 | 2.80 Micromoles per liter | Standard Deviation 8.917 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 8,n=34,31,24,22,23 | 0.0 Micromoles per liter | Standard Deviation 0.29 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 12,n=32,28,24,22,21 | 0.2 Micromoles per liter | Standard Deviation 0.96 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 24,n=22,21,16,17,16 | 1.86 Micromoles per liter | Standard Deviation 9.364 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 16,n=28,26,22,19,18 | 0.3 Micromoles per liter | Standard Deviation 0.63 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 20,n=25,23,19,18,16 | 0.4 Micromoles per liter | Standard Deviation 0.77 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 24,n=22,21,16,17,16 | 0.4 Micromoles per liter | Standard Deviation 0.81 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 28,n=19,18,12,13,14 | 0.1 Micromoles per liter | Standard Deviation 0.9 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 32,n=19,15,10,12,13 | 0.1 Micromoles per liter | Standard Deviation 0.32 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 28,n=19,18,12,13,14 | -1.33 Micromoles per liter | Standard Deviation 5.372 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 36,n=15,12,10,12,13 | -0.1 Micromoles per liter | Standard Deviation 0.74 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 40,n=15,11,6,10,10 | -0.3 Micromoles per liter | Standard Deviation 0.71 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 44,n=11,11,6,8,9 | 0.2 Micromoles per liter | Standard Deviation 0.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 48,n=9,8,5,8,5 | -0.6 Micromoles per liter | Standard Deviation 1.34 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 52,n=9,5,5,5,4 | -0.2 Micromoles per liter | Standard Deviation 1.1 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 32,n=19,15,10,12,13 | -1.33 Micromoles per liter | Standard Deviation 7.598 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 2,n=38,39,26,24,26 | 1.8 Micromoles per liter | Standard Deviation 3.18 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 4,n=37,38,25,23,27 | 1.8 Micromoles per liter | Standard Deviation 2.31 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 8,n=34,31,24,22,23 | 0.9 Micromoles per liter | Standard Deviation 2.9 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 12,n=32,28,24,22,21 | 2.5 Micromoles per liter | Standard Deviation 2.87 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 16,n=28,26,22,19,18 | 3.6 Micromoles per liter | Standard Deviation 3.22 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 36,n=15,12,10,12,13 | 0.88 Micromoles per liter | Standard Deviation 7.151 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 20,n=25,23,19,18,16 | 3.2 Micromoles per liter | Standard Deviation 3.21 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 24,n=22,21,16,17,16 | 4.4 Micromoles per liter | Standard Deviation 3.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 28,n=19,18,12,13,14 | 3.0 Micromoles per liter | Standard Deviation 3.02 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 32,n=19,15,10,12,13 | 2.6 Micromoles per liter | Standard Deviation 2.99 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 36,n=15,12,10,12,13 | 2.4 Micromoles per liter | Standard Deviation 2.63 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 40,n=15,11,6,10,10 | -0.88 Micromoles per liter | Standard Deviation 9.831 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 40,n=15,11,6,10,10 | 2.9 Micromoles per liter | Standard Deviation 2.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 44,n=11,11,6,8,9 | 2.3 Micromoles per liter | Standard Deviation 2.34 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 48,n=9,8,5,8,5 | 2.8 Micromoles per liter | Standard Deviation 2.28 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 52,n=9,5,5,5,4 | 4.20 Micromoles per liter | Standard Deviation 9.195 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 52,n=9,5,5,5,4 | 5.2 Micromoles per liter | Standard Deviation 5.02 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 2,n=38,39,26,24,26 | 0.71 Micromoles per liter | Standard Deviation 5.17 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 44,n=11,11,6,8,9 | -2.38 Micromoles per liter | Standard Deviation 7.847 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 4,n=37,38,25,23,27 | 2.56 Micromoles per liter | Standard Deviation 6.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 8,n=34,31,24,22,23 | 0.95 Micromoles per liter | Standard Deviation 6.027 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 2,n=38,39,26,24,26 | 1.9 Micromoles per liter | Standard Deviation 3.73 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 4,n=37,38,25,23,27 | 1.8 Micromoles per liter | Standard Deviation 2.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 12,n=32,28,24,22,21 | 3.28 Micromoles per liter | Standard Deviation 6.334 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 8,n=34,31,24,22,23 | 0.9 Micromoles per liter | Standard Deviation 2.95 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 12,n=32,28,24,22,21 | 2.7 Micromoles per liter | Standard Deviation 3.44 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 16,n=28,26,22,19,18 | 3.9 Micromoles per liter | Standard Deviation 3.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 24,n=22,21,16,17,16 | 4.8 Micromoles per liter | Standard Deviation 3.6 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 16,n=28,26,22,19,18 | 1.27 Micromoles per liter | Standard Deviation 6.604 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 28,n=19,18,12,13,14 | 3.1 Micromoles per liter | Standard Deviation 3.18 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 32,n=19,15,10,12,13 | 2.7 Micromoles per liter | Standard Deviation 2.91 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 36,n=15,12,10,12,13 | 2.3 Micromoles per liter | Standard Deviation 2.91 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 40,n=15,11,6,10,10 | 2.6 Micromoles per liter | Standard Deviation 2.07 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 40,n=15,11,6,10,10 | -1.1 Micromoles per liter | Standard Deviation 2.02 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 28,n=19,18,12,13,14 | -0.5 Micromoles per liter | Standard Deviation 0.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 12,n=32,28,24,22,21 | -0.1 Micromoles per liter | Standard Deviation 0.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 40,n=15,11,6,10,10 | 1.67 Micromoles per liter | Standard Deviation 9.527 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 2,n=38,39,26,24,26 | -1.1 Micromoles per liter | Standard Deviation 1.94 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 48,n=9,8,5,8,5 | -1.1 Micromoles per liter | Standard Deviation 1.96 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 52,n=9,5,5,5,4 | -1.0 Micromoles per liter | Standard Deviation 2 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 8,n=34,31,24,22,23 | -0.1 Micromoles per liter | Standard Deviation 0.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 44,n=11,11,6,8,9 | -0.1 Micromoles per liter | Standard Deviation 2.03 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 32,n=19,15,10,12,13 | -0.6 Micromoles per liter | Standard Deviation 2.35 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 32,n=19,15,10,12,13 | -0.2 Micromoles per liter | Standard Deviation 0.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 48,n=9,8,5,8,5 | 1.43 Micromoles per liter | Standard Deviation 5.646 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 44,n=11,11,6,8,9 | -0.1 Micromoles per liter | Standard Deviation 2.03 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 8,n=34,31,24,22,23 | -2.3 Micromoles per liter | Standard Deviation 2.5 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 48,n=9,8,5,8,5 | -1.1 Micromoles per liter | Standard Deviation 1.96 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 12,n=32,28,24,22,21 | -3.09 Micromoles per liter | Standard Deviation 7.615 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 4,n=37,38,25,23,27 | -0.2 Micromoles per liter | Standard Deviation 0.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 36,n=15,12,10,12,13 | -0.9 Micromoles per liter | Standard Deviation 1.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 12,n=32,28,24,22,21 | -1.0 Micromoles per liter | Standard Deviation 2.4 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 24,n=22,21,16,17,16 | -0.8 Micromoles per liter | Standard Deviation 1.64 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 28,n=19,18,12,13,14 | -0.8 Micromoles per liter | Standard Deviation 1.92 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 48,n=9,8,5,8,5 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 20,n=25,23,19,18,16 | -0.2 Micromoles per liter | Standard Deviation 0.65 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 24,n=22,21,16,17,16 | -1.1 Micromoles per liter | Standard Deviation 1.8 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 52,n=9,5,5,5,4 | -0.6 Micromoles per liter | Standard Deviation 1.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 36,n=15,12,10,12,13 | -0.8 Micromoles per liter | Standard Deviation 1.66 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 52,n=9,5,5,5,4 | -0.4 Micromoles per liter | Standard Deviation 0.89 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 24,n=22,21,16,17,16 | -1.14 Micromoles per liter | Standard Deviation 8.093 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 28,n=19,18,12,13,14 | -0.3 Micromoles per liter | Standard Deviation 1.8 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 44,n=11,11,6,8,9 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 16,n=28,26,22,19,18 | -0.9 Micromoles per liter | Standard Deviation 1.85 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 2,n=38,39,26,24,26 | -1.1 Micromoles per liter | Standard Deviation 1.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 16,n=28,26,22,19,18 | -0.14 Micromoles per liter | Standard Deviation 9.654 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 32,n=19,15,10,12,13 | 0.59 Micromoles per liter | Standard Deviation 7.911 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 2,n=38,39,26,24,26 | -1.65 Micromoles per liter | Standard Deviation 6.165 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 36,n=15,12,10,12,13 | 4.56 Micromoles per liter | Standard Deviation 9.011 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 4,n=37,38,25,23,27 | -1.6 Micromoles per liter | Standard Deviation 2.19 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 20,n=25,23,19,18,16 | -0.18 Micromoles per liter | Standard Deviation 6.991 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 16,n=28,26,22,19,18 | -0.1 Micromoles per liter | Standard Deviation 0.46 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 40,n=15,11,6,10,10 | -1.1 Micromoles per liter | Standard Deviation 2.02 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 52,n=9,5,5,5,4 | 1.78 Micromoles per liter | Standard Deviation 9.836 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 8,n=34,31,24,22,23 | -2.2 Micromoles per liter | Standard Deviation 2.47 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 4,n=37,38,25,23,27 | -0.64 Micromoles per liter | Standard Deviation 5.781 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 24,n=22,21,16,17,16 | -0.4 Micromoles per liter | Standard Deviation 0.79 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 40,n=15,11,6,10,10 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 44,n=11,11,6,8,9 | 0.23 Micromoles per liter | Standard Deviation 7.876 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 12,n=32,28,24,22,21 | -1.0 Micromoles per liter | Standard Deviation 2.63 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 4,n=37,38,25,23,27 | -1.8 Micromoles per liter | Standard Deviation 2.52 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 28,n=19,18,12,13,14 | -0.28 Micromoles per liter | Standard Deviation 4.97 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 32,n=19,15,10,12,13 | -0.8 Micromoles per liter | Standard Deviation 2.53 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 2,n=38,39,26,24,26 | 0.0 Micromoles per liter | Standard Deviation 0.59 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 16,n=28,26,22,19,18 | -0.8 Micromoles per liter | Standard Deviation 1.84 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 8,n=34,31,24,22,23 | -2.93 Micromoles per liter | Standard Deviation 7.703 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 20,n=25,23,19,18,16 | -1.4 Micromoles per liter | Standard Deviation 2.2 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 36,n=15,12,10,12,13 | -0.2 Micromoles per liter | Standard Deviation 0.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 20,n=25,23,19,18,16 | -1.2 Micromoles per liter | Standard Deviation 2.23 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 20,n=25,23,19,18,16 | -3.1 Micromoles per liter | Standard Deviation 4.67 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 20,n=25,23,19,18,16 | -2.2 Micromoles per liter | Standard Deviation 3.47 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 32,n=19,15,10,12,13 | -1.2 Micromoles per liter | Standard Deviation 1.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 24,n=22,21,16,17,16 | -0.9 Micromoles per liter | Standard Deviation 2.62 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 36,n=15,12,10,12,13 | 3.62 Micromoles per liter | Standard Deviation 11.433 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 52,n=9,5,5,5,4 | 1.8 Micromoles per liter | Standard Deviation 6.85 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 28,n=19,18,12,13,14 | -2.2 Micromoles per liter | Standard Deviation 2.55 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 28,n=19,18,12,13,14 | -1.0 Micromoles per liter | Standard Deviation 1.52 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 32,n=19,15,10,12,13 | -1.8 Micromoles per liter | Standard Deviation 2.52 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 24,n=22,21,16,17,16 | -0.8 Micromoles per liter | Standard Deviation 1.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 36,n=15,12,10,12,13 | -0.8 Micromoles per liter | Standard Deviation 3.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 24,n=22,21,16,17,16 | -1.7 Micromoles per liter | Standard Deviation 3.34 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 44,n=11,11,6,8,9 | -1.2 Micromoles per liter | Standard Deviation 3.23 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 40,n=15,11,6,10,10 | -0.5 Micromoles per liter | Standard Deviation 2.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 24,n=22,21,16,17,16 | 2.63 Micromoles per liter | Standard Deviation 7.834 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 44,n=11,11,6,8,9 | -0.6 Micromoles per liter | Standard Deviation 2.88 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 40,n=15,11,6,10,10 | 1.55 Micromoles per liter | Standard Deviation 10.63 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 20,n=25,23,19,18,16 | -0.9 Micromoles per liter | Standard Deviation 1.45 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 48,n=9,8,5,8,5 | -0.6 Micromoles per liter | Standard Deviation 2.19 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 28,n=19,18,12,13,14 | -3.2 Micromoles per liter | Standard Deviation 3.72 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 52,n=9,5,5,5,4 | 2.3 Micromoles per liter | Standard Deviation 6.13 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 16,n=28,26,22,19,18 | -0.8 Micromoles per liter | Standard Deviation 1.4 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 2,n=38,39,26,24,26 | 0.28 Micromoles per liter | Standard Deviation 7.485 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 4,n=37,38,25,23,27 | 0.48 Micromoles per liter | Standard Deviation 7.222 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 12,n=32,28,24,22,21 | -0.6 Micromoles per liter | Standard Deviation 1.29 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,Week 8,n=34,31,24,22,23 | 2.43 Micromoles per liter | Standard Deviation 8.688 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 44,n=11,11,6,8,9 | 3.96 Micromoles per liter | Standard Deviation 14.656 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 32,n=19,15,10,12,13 | -3.0 Micromoles per liter | Standard Deviation 3.74 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 2,n=38,39,26,24,26 | -1.0 Micromoles per liter | Standard Deviation 3.45 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 8,n=34,31,24,22,23 | -0.8 Micromoles per liter | Standard Deviation 1.31 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 16,n=28,26,22,19,18 | 3.37 Micromoles per liter | Standard Deviation 15.068 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 4,n=37,38,25,23,27 | -1.5 Micromoles per liter | Standard Deviation 5.22 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 48,n=9,8,5,8,5 | -1.8 Micromoles per liter | Standard Deviation 2.49 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 4,n=37,38,25,23,27 | -0.6 Micromoles per liter | Standard Deviation 1.31 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 40,n=15,11,6,10,10 | -1.9 Micromoles per liter | Standard Deviation 4.18 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 8,n=34,31,24,22,23 | -3.2 Micromoles per liter | Standard Deviation 5.31 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 12,n=32,28,24,22,21 | -2.9 Micromoles per liter | Standard Deviation 4.52 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 12,n=32,28,24,22,21 | 1.46 Micromoles per liter | Standard Deviation 6.093 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 48,n=9,8,5,8,5 | -1.2 Micromoles per liter | Standard Deviation 1.1 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 48,n=9,8,5,8,5 | 5.72 Micromoles per liter | Standard Deviation 18.804 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 44,n=11,11,6,8,9 | -0.7 Micromoles per liter | Standard Deviation 1 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 20,n=25,23,19,18,16 | 4.73 Micromoles per liter | Standard Deviation 12.179 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 52,n=9,5,5,5,4 | -0.5 Micromoles per liter | Standard Deviation 1 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 36,n=15,12,10,12,13 | -2.1 Micromoles per liter | Standard Deviation 4.91 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 2,n=38,39,26,24,26 | -0.7 Micromoles per liter | Standard Deviation 3.19 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 28,n=19,18,12,13,14 | 4.07 Micromoles per liter | Standard Deviation 7.431 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Bilirubin,Week 16,n=28,26,22,19,18 | -3.3 Micromoles per liter | Standard Deviation 4.25 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 4,n=37,38,25,23,27 | -0.9 Micromoles per liter | Standard Deviation 4.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine, Week 32,n=19,15,10,12,13 | 4.10 Micromoles per liter | Standard Deviation 7.264 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 40,n=15,11,6,10,10 | -1.4 Micromoles per liter | Standard Deviation 1.35 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 8,n=34,31,24,22,23 | -2.4 Micromoles per liter | Standard Deviation 4.34 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Creatinine,,Week 52,n=9,5,5,5,4 | 12.23 Micromoles per liter | Standard Deviation 16.814 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 2,n=38,39,26,24,26 | -0.3 Micromoles per liter | Standard Deviation 0.75 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 12,n=32,28,24,22,21 | -2.3 Micromoles per liter | Standard Deviation 3.79 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Direct Bilirubin,Week 36,n=15,12,10,12,13 | -1.2 Micromoles per liter | Standard Deviation 1.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin | Indirect Bilirubin,Week 16,n=28,26,22,19,18 | -2.5 Micromoles per liter | Standard Deviation 3 |
Secondary
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 32,n=19,15,10,12,13 | 0.16 Millimoles per liter | Standard Deviation 0.437 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 32,n=19,15,10,12,13 | -0.74 Millimoles per liter | Standard Deviation 3.492 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 20,n=25,23,19,18,16 | 3.3 Millimoles per liter | Standard Deviation 2.88 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 44,n=11,11,6,8,9 | 0.042 Millimoles per liter | Standard Deviation 0.148 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 24,n=22,21,16,17,16 | 0.9 Millimoles per liter | Standard Deviation 2.31 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 4,n=37,38,25,23,27 | 0.071 Millimoles per liter | Standard Deviation 0.1944 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 16,n=28,26,22,19,18 | -0.71 Millimoles per liter | Standard Deviation 2.485 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 24,n=22,21,16,17,16 | -0.72 Millimoles per liter | Standard Deviation 2.701 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 16,n=28,26,22,19,18 | 3.0 Millimoles per liter | Standard Deviation 2.27 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 28,n=19,18,12,13,14 | 0.9 Millimoles per liter | Standard Deviation 2.27 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 36,n=15,12,10,12,13 | 0.16 Millimoles per liter | Standard Deviation 0.429 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 52,n=9,5,5,5,4 | 4.8 Millimoles per liter | Standard Deviation 1.09 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 4,n=37,38,25,23,27 | 0.009 Millimoles per liter | Standard Deviation 0.0974 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 44,n=11,11,6,8,9 | 0.142 Millimoles per liter | Standard Deviation 0.2117 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 32,n=19,15,10,12,13 | 0.7 Millimoles per liter | Standard Deviation 2.31 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 48,n=9,8,5,8,5 | -0.007 Millimoles per liter | Standard Deviation 0.1126 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 8,n=34,31,24,22,23 | 1.1 Millimoles per liter | Standard Deviation 2.1 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 28,n=19,18,12,13,14 | 0.12 Millimoles per liter | Standard Deviation 0.288 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 8,n=34,31,24,22,23 | 0.01 Millimoles per liter | Standard Deviation 0.364 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 36,n=15,12,10,12,13 | 0.5 Millimoles per liter | Standard Deviation 1.96 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 36,n=15,12,10,12,13 | 3.8 Millimoles per liter | Standard Deviation 1.74 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 36,n=15,12,10,12,13 | -1.14 Millimoles per liter | Standard Deviation 3.268 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 12,n=32,28,24,22,21 | 2.9 Millimoles per liter | Standard Deviation 2.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 24,n=22,21,16,17,16 | 0.008 Millimoles per liter | Standard Deviation 0.1029 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 40,n=15,11,9,10,10 | 0.1 Millimoles per liter | Standard Deviation 2.17 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 2,n=38,39,26,24,26 | 0.002 Millimoles per liter | Standard Deviation 0.1056 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 52,n=9,5,5,5,4 | 0.013 Millimoles per liter | Standard Deviation 0.0907 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 48,n=9,8,5,8,5 | 0.21 Millimoles per liter | Standard Deviation 0.352 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 12,n=32,28,24,22,21 | 0.019 Millimoles per liter | Standard Deviation 0.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 44,n=11,11,6,8,9 | 0.5 Millimoles per liter | Standard Deviation 1.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 12,n=32,28,24,22,21 | 0.122 Millimoles per liter | Standard Deviation 0.2404 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 2,n=38,39,26,24,26 | 0.3 Millimoles per liter | Standard Deviation 2.11 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 4,n=37,38,25,23,27 | 0.1 Millimoles per liter | Standard Deviation 2.03 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 8,n=34,31,24,22,23 | 2.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 48,n=9,8,5,8,5 | -0.3 Millimoles per liter | Standard Deviation 1.87 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 16,n=28,26,22,19,18 | 0.1 Millimoles per liter | Standard Deviation 2.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 2,n=38,39,26,24,26 | 0.7 Millimoles per liter | Standard Deviation 2.42 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 2,n=38,39,26,24,26 | 0.056 Millimoles per liter | Standard Deviation 0.2249 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 48,n=9,8,5,8,5 | 0.029 Millimoles per liter | Standard Deviation 0.2136 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 52,n=9,5,5,5,4 | 0.7 Millimoles per liter | Standard Deviation 1.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 28,n=19,18,12,13,14 | 0.006 Millimoles per liter | Standard Deviation 0.1102 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 40,n=15,11,9,10,10 | -0.99 Millimoles per liter | Standard Deviation 3.465 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 4,n=37,38,25,23,27 | 1.8 Millimoles per liter | Standard Deviation 2.34 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 12,n=32,28,24,22,21 | -0.12 Millimoles per liter | Standard Deviation 0.333 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 2,n=38,39,26,24,26 | 0.05 Millimoles per liter | Standard Deviation 1.21 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 40,n=15,11,9,10,10 | 3.3 Millimoles per liter | Standard Deviation 2.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 4,n=37,38,25,23,27 | -0.10 Millimoles per liter | Standard Deviation 2.676 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 4,n=37,38,25,23,27 | -0.13 Millimoles per liter | Standard Deviation 0.319 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 16,n=28,26,22,19,18 | 0.113 Millimoles per liter | Standard Deviation 0.1976 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 4,n=37,38,25,23,27 | -0.09 Millimoles per liter | Standard Deviation 1.592 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 24,n=22,21,16,17,16 | 0.4 Millimoles per liter | Standard Deviation 3.1 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 12,n=32,28,24,22,21 | -0.64 Millimoles per liter | Standard Deviation 2.219 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 2,n=38,39,26,24,26 | 1.1 Millimoles per liter | Standard Deviation 2.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 8,n=34,31,24,22,23 | -0.29 Millimoles per liter | Standard Deviation 2.507 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 8,n=34,31,24,22,23 | -0.36 Millimoles per liter | Standard Deviation 1.938 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 32,n=19,15,10,12,13 | 3.4 Millimoles per liter | Standard Deviation 2.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 16,n=28,26,22,19,18 | 1.0 Millimoles per liter | Standard Deviation 2.28 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 20,n=25,23,19,18,16 | 0.070 Millimoles per liter | Standard Deviation 0.186 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 52,n=9,5,5,5,4 | -1.1 Millimoles per liter | Standard Deviation 1.76 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 12,n=32,28,24,22,21 | -0.65 Millimoles per liter | Standard Deviation 1.617 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 40,n=15,11,9,10,10 | 0.24 Millimoles per liter | Standard Deviation 0.534 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 44,n=11,11,6,8,9 | -1.39 Millimoles per liter | Standard Deviation 3.789 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 32,n=19,15,10,12,13 | 0.029 Millimoles per liter | Standard Deviation 0.1119 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 52,n=9,5,5,5,4 | 0.22 Millimoles per liter | Standard Deviation 0.186 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 16,n=28,26,22,19,18 | -0.56 Millimoles per liter | Standard Deviation 2.009 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 16,n=28,26,22,19,18 | 0.009 Millimoles per liter | Standard Deviation 0.0974 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 24,n=22,21,16,17,16 | 0.132 Millimoles per liter | Standard Deviation 0.2066 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 12,n=32,28,24,22,21 | 1.8 Millimoles per liter | Standard Deviation 2.46 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 16,n=28,26,22,19,18 | 0.01 Millimoles per liter | Standard Deviation 0.376 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 20,n=25,23,19,18,16 | -0.30 Millimoles per liter | Standard Deviation 1.675 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 2,n=38,39,26,24,26 | -0.03 Millimoles per liter | Standard Deviation 2.568 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 12,n=32,28,24,22,21 | 0.1 Millimoles per liter | Standard Deviation 2.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 48,n=9,8,5,8,5 | -2.6 Millimoles per liter | Standard Deviation 2.7 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 28,n=19,18,12,13,14 | -0.91 Millimoles per liter | Standard Deviation 2.99 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 24,n=22,21,16,17,16 | -0.48 Millimoles per liter | Standard Deviation 1.901 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 28,n=19,18,12,13,14 | 0.156 Millimoles per liter | Standard Deviation 0.1873 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 48,n=9,8,5,8,5 | 4.6 Millimoles per liter | Standard Deviation 1.88 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 44,n=11,11,6,8,9 | 0.16 Millimoles per liter | Standard Deviation 0.287 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 8,n=34,31,24,22,23 | 0.032 Millimoles per liter | Standard Deviation 0.1114 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 28,n=19,18,12,13,14 | -0.45 Millimoles per liter | Standard Deviation 1.745 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 52,n=9,5,5,5,4 | 0.049 Millimoles per liter | Standard Deviation 0.2235 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 48,n=9,8,5,8,5 | -1.39 Millimoles per liter | Standard Deviation 4.249 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 28,n=19,18,12,13,14 | 3.9 Millimoles per liter | Standard Deviation 3.13 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 44,n=11,11,6,8,9 | -1.7 Millimoles per liter | Standard Deviation 2.72 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 32,n=19,15,10,12,13 | -0.16 Millimoles per liter | Standard Deviation 2.086 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 2,n=38,39,26,24,26 | 0.03 Millimoles per liter | Standard Deviation 0.372 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 32,n=19,15,10,12,13 | 0.164 Millimoles per liter | Standard Deviation 0.1166 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 36,n=15,12,10,12,13 | 0.016 Millimoles per liter | Standard Deviation 0.0789 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 20,n=25,23,19,18,16 | -0.66 Millimoles per liter | Standard Deviation 2.701 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 36,n=15,12,10,12,13 | 0.06 Millimoles per liter | Standard Deviation 1.967 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 4,n=37,38,25,23,27 | 0.7 Millimoles per liter | Standard Deviation 2.15 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 20,n=25,23,19,18,16 | 0.1 Millimoles per liter | Standard Deviation 2.98 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 40,n=15,11,6,10,10 | -1.5 Millimoles per liter | Standard Deviation 3.16 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 20,n=25,23,19,18,16 | 0.04 Millimoles per liter | Standard Deviation 0.394 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 40,n=15,11,9,10,10 | -0.17 Millimoles per liter | Standard Deviation 1.775 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 8,n=34,31,24,22,23 | 0.088 Millimoles per liter | Standard Deviation 0.1786 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 44,n=11,11,6,8,9 | 3.8 Millimoles per liter | Standard Deviation 2.23 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 36,n=15,12,10,12,13 | 0.111 Millimoles per liter | Standard Deviation 0.1786 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 28,n=19,18,12,13,14 | -1.6 Millimoles per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 44,n=11,11,6,8,9 | -0.46 Millimoles per liter | Standard Deviation 3.119 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 40,n=15,11,9,10,10 | 0.077 Millimoles per liter | Standard Deviation 0.1012 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 52,n=9,5,5,5,4 | -1.51 Millimoles per liter | Standard Deviation 4.466 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 36,n=15,12,10,12,13 | -1.1 Millimoles per liter | Standard Deviation 2.28 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 24,n=22,21,16,17,16 | 3.4 Millimoles per liter | Standard Deviation 3.42 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 48,n=9,8,5,8,5 | -0.18 Millimoles per liter | Standard Deviation 3.535 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 20,n=25,23,19,18,16 | 1.0 Millimoles per liter | Standard Deviation 2.23 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 40,n=15,11,6,10,10 | 0.221 Millimoles per liter | Standard Deviation 0.1902 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 20,n=25,23,19,18,16 | 0.018 Millimoles per liter | Standard Deviation 0.108 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 32,n=19,15,10,12,13 | -1.0 Millimoles per liter | Standard Deviation 3.65 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 52,n=9,5,5,5,4 | -0.26 Millimoles per liter | Standard Deviation 2.508 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 24,n=22,21,16,17,16 | 0.05 Millimoles per liter | Standard Deviation 0.447 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 8,n=34,31,24,22,23 | 0.1 Millimoles per liter | Standard Deviation 3.39 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 40,n=15,11,9,10,10 | 3.6 Millimoles per liter | Standard Deviation 1.12 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 28,n=19,18,12,13,14 | 0.4 Millimoles per liter | Standard Deviation 3.63 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 2,n=38,39,26,24,26 | 0.006 Millimoles per liter | Standard Deviation 0.0853 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 4,n=37,38,25,23,27 | 0.008 Millimoles per liter | Standard Deviation 0.0968 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 24,n=22,21,16,17,16 | -0.01 Millimoles per liter | Standard Deviation 0.403 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 8,n=34,31,24,22,23 | 0.049 Millimoles per liter | Standard Deviation 0.0879 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 2,n=38,39,26,24,26 | -0.004 Millimoles per liter | Standard Deviation 0.193 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 24,n=22,21,16,17,16 | 0.4 Millimoles per liter | Standard Deviation 3.11 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 12,n=32,28,24,22,21 | -0.63 Millimoles per liter | Standard Deviation 2.134 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 12,n=32,28,24,22,21 | 0.072 Millimoles per liter | Standard Deviation 0.0789 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 20,n=25,23,19,18,16 | -0.1 Millimoles per liter | Standard Deviation 3.17 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 16,n=28,26,22,19,18 | 0.050 Millimoles per liter | Standard Deviation 0.0808 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 12,n=32,28,24,22,21 | 0.5 Millimoles per liter | Standard Deviation 3.9 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 44,n=11,11,6,8,9 | 0.025 Millimoles per liter | Standard Deviation 0.1874 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 20,n=25,23,19,18,16 | 0.070 Millimoles per liter | Standard Deviation 0.0987 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 16,n=28,26,22,19,18 | 0.5 Millimoles per liter | Standard Deviation 2.47 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 24,n=22,21,16,17,16 | 0.064 Millimoles per liter | Standard Deviation 0.0927 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 4,n=37,38,25,23,27 | -0.011 Millimoles per liter | Standard Deviation 0.2501 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 28,n=19,18,12,13,14 | 0.07 Millimoles per liter | Standard Deviation 0.47 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 28,n=19,18,12,13,14 | 0.066 Millimoles per liter | Standard Deviation 0.1106 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 12,n=32,28,24,22,21 | 0.6 Millimoles per liter | Standard Deviation 2.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 36,n=15,12,10,12,13 | 2.4 Millimoles per liter | Standard Deviation 2.78 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 32,n=19,15,10,12,13 | 0.044 Millimoles per liter | Standard Deviation 0.0923 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 8,n=34,31,24,22,23 | -0.58 Millimoles per liter | Standard Deviation 2.606 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 36,n=15,12,10,12,13 | -0.07 Millimoles per liter | Standard Deviation 0.475 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 36,n=15,12,10,12,13 | 0.055 Millimoles per liter | Standard Deviation 0.0773 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 8,n=34,31,24,22,23 | 0.3 Millimoles per liter | Standard Deviation 2.89 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 40,n=15,11,9,10,10 | 0.016 Millimoles per liter | Standard Deviation 0.0662 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 8,n=34,31,24,22,23 | 0.091 Millimoles per liter | Standard Deviation 0.2098 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 44,n=11,11,6,8,9 | 0.025 Millimoles per liter | Standard Deviation 0.0908 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 32,n=19,15,10,12,13 | 0.01 Millimoles per liter | Standard Deviation 0.448 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 48,n=9,8,5,8,5 | 0.028 Millimoles per liter | Standard Deviation 0.0956 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 4,n=37,38,25,23,27 | 0.2 Millimoles per liter | Standard Deviation 2.68 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 52,n=9,5,5,5,4 | -0.16 Millimoles per liter | Standard Deviation 0.434 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 52,n=9,5,5,5,4 | 0.076 Millimoles per liter | Standard Deviation 0.1108 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 52,n=9,5,5,5,4 | -0.036 Millimoles per liter | Standard Deviation 0.2779 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 2,n=38,39,26,24,26 | 0.6 Millimoles per liter | Standard Deviation 2.55 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 12,n=32,28,24,22,21 | 0.154 Millimoles per liter | Standard Deviation 0.2377 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 24,n=22,21,16,17,16 | -0.44 Millimoles per liter | Standard Deviation 1.632 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 32,n=19,15,10,12,13 | 1.9 Millimoles per liter | Standard Deviation 2.59 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 16,n=28,26,22,19,18 | 0.139 Millimoles per liter | Standard Deviation 0.2315 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 20,n=25,23,19,18,16 | 0.160 Millimoles per liter | Standard Deviation 0.2436 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 2,n=38,39,26,24,26 | -0.46 Millimoles per liter | Standard Deviation 1.671 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 16,n=28,26,22,19,18 | 0.6 Millimoles per liter | Standard Deviation 3.09 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 24,n=22,21,16,17,16 | 0.163 Millimoles per liter | Standard Deviation 0.2383 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 28,n=19,18,12,13,14 | 2.8 Millimoles per liter | Standard Deviation 2.8 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 28,n=19,18,12,13,14 | 0.090 Millimoles per liter | Standard Deviation 0.2543 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 28,n=19,18,12,13,14 | -0.32 Millimoles per liter | Standard Deviation 1.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 32,n=19,15,10,12,13 | 0.101 Millimoles per liter | Standard Deviation 0.216 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 24,n=22,21,16,17,16 | 2.7 Millimoles per liter | Standard Deviation 2.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 4,n=37,38,25,23,27 | -0.04 Millimoles per liter | Standard Deviation 0.412 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 36,n=15,12,10,12,13 | 0.068 Millimoles per liter | Standard Deviation 0.2204 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 2,n=38,39,26,24,26 | 0.0 Millimoles per liter | Standard Deviation 2.33 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 40,n=15,11,6,10,10 | -0.007 Millimoles per liter | Standard Deviation 0.2007 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 52,n=9,5,5,5,4 | 2.2 Millimoles per liter | Standard Deviation 1.64 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 20,n=25,23,19,18,16 | 2.0 Millimoles per liter | Standard Deviation 2.11 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 20,n=25,23,19,18,16 | 0.6 Millimoles per liter | Standard Deviation 2.79 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 32,n=19,15,10,12,13 | -0.48 Millimoles per liter | Standard Deviation 1.533 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 24,n=22,21,16,17,16 | 1.0 Millimoles per liter | Standard Deviation 1.83 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 16,n=28,26,22,19,18 | 2.3 Millimoles per liter | Standard Deviation 2.54 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 28,n=19,18,12,13,14 | 1.2 Millimoles per liter | Standard Deviation 2.75 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 48,n=9,8,5,8,5 | 0.06 Millimoles per liter | Standard Deviation 0.644 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 32,n=19,15,10,12,13 | -0.3 Millimoles per liter | Standard Deviation 2.63 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 12,n=32,28,24,22,21 | 1.8 Millimoles per liter | Standard Deviation 3.03 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 36,n=15,12,10,12,13 | 0.6 Millimoles per liter | Standard Deviation 2.43 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 8,n=34,31,24,22,23 | 0.05 Millimoles per liter | Standard Deviation 0.437 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 40,n=15,11,9,10,10 | 1.2 Millimoles per liter | Standard Deviation 2.23 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 36,n=15,12,10,12,13 | -0.35 Millimoles per liter | Standard Deviation 1.861 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 16,n=28,26,22,19,18 | 0.33 Millimoles per liter | Standard Deviation 1.941 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 44,n=11,11,6,8,9 | 0.4 Millimoles per liter | Standard Deviation 2.58 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 8,n=34,31,24,22,23 | 2.4 Millimoles per liter | Standard Deviation 2.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 48,n=9,8,5,8,5 | 0.8 Millimoles per liter | Standard Deviation 2.76 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 8,n=34,31,24,22,23 | 0.9 Millimoles per liter | Standard Deviation 3.12 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 4,n=37,38,25,23,27 | 1.6 Millimoles per liter | Standard Deviation 2.1 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 52,n=9,5,5,5,4 | 0.4 Millimoles per liter | Standard Deviation 2.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 2,n=38,39,26,24,26 | -0.16 Millimoles per liter | Standard Deviation 1.776 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 40,n=15,11,9,10,10 | -0.33 Millimoles per liter | Standard Deviation 2.376 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 2,n=38,39,26,24,26 | 0.6 Millimoles per liter | Standard Deviation 1.79 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 12,n=32,28,24,22,21 | 0.15 Millimoles per liter | Standard Deviation 0.81 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 4,n=37,38,25,23,27 | -0.61 Millimoles per liter | Standard Deviation 1.514 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 48,n=9,8,5,8,5 | 2.1 Millimoles per liter | Standard Deviation 2.23 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 8,n=34,31,24,22,23 | -0.99 Millimoles per liter | Standard Deviation 1.826 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 4,n=37,38,25,23,27 | -0.35 Millimoles per liter | Standard Deviation 1.929 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 52,n=9,5,5,5,4 | 1.2 Millimoles per liter | Standard Deviation 2.68 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 12,n=32,28,24,22,21 | -1.20 Millimoles per liter | Standard Deviation 1.778 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 44,n=11,11,6,8,9 | -0.13 Millimoles per liter | Standard Deviation 0.478 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 48,n=9,8,5,8,5 | -0.054 Millimoles per liter | Standard Deviation 0.2203 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 16,n=28,26,22,19,18 | -0.52 Millimoles per liter | Standard Deviation 1.612 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 44,n=11,11,6,8,9 | -0.05 Millimoles per liter | Standard Deviation 1.954 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 48,n=9,8,5,8,5 | 0.5 Millimoles per liter | Standard Deviation 3.59 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 20,n=25,23,19,18,16 | -0.70 Millimoles per liter | Standard Deviation 1.379 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 4,n=37,38,25,23,27 | 0.4 Millimoles per liter | Standard Deviation 2.11 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 16,n=28,26,22,19,18 | 0.03 Millimoles per liter | Standard Deviation 0.439 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 24,n=22,21,16,17,16 | -0.22 Millimoles per liter | Standard Deviation 2.044 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 2,n=38,39,26,24,26 | -0.03 Millimoles per liter | Standard Deviation 0.437 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 28,n=19,18,12,13,14 | -0.42 Millimoles per liter | Standard Deviation 1.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 44,n=11,11,6,8,9 | 1.6 Millimoles per liter | Standard Deviation 3.5 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 32,n=19,15,10,12,13 | -0.64 Millimoles per liter | Standard Deviation 1.479 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 48,n=9,8,5,8,5 | -0.93 Millimoles per liter | Standard Deviation 2.077 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 40,n=15,11,6,10,10 | 0.9 Millimoles per liter | Standard Deviation 3.75 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 36,n=15,12,10,12,13 | -1.43 Millimoles per liter | Standard Deviation 1.828 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 44,n=11,11,6,8,9 | 3.4 Millimoles per liter | Standard Deviation 1.91 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 40,n=15,11,9,10,10 | -0.78 Millimoles per liter | Standard Deviation 0.603 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 36,n=15,12,10,12,13 | 0.3 Millimoles per liter | Standard Deviation 3.72 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 20,n=25,23,19,18,16 | 0.07 Millimoles per liter | Standard Deviation 0.556 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 44,n=11,11,6,8,9 | -1.05 Millimoles per liter | Standard Deviation 1.234 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 52,n=9,5,5,5,4 | -0.94 Millimoles per liter | Standard Deviation 2.707 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 48,n=9,8,5,8,5 | -1.58 Millimoles per liter | Standard Deviation 1.45 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 20,n=25,23,19,18,16 | -0.46 Millimoles per liter | Standard Deviation 1.55 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 32,n=19,15,10,12,13 | 0.8 Millimoles per liter | Standard Deviation 2.08 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 52,n=9,5,5,5,4 | -1.22 Millimoles per liter | Standard Deviation 1.671 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 40,n=15,11,9,10,10 | -0.03 Millimoles per liter | Standard Deviation 0.476 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 8,n=34,31,24,22,23 | -0.40 Millimoles per liter | Standard Deviation 1.574 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 2,n=38,39,26,24,26 | -0.02 Millimoles per liter | Standard Deviation 0.401 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 12,n=32,28,24,22,21 | -0.33 Millimoles per liter | Standard Deviation 1.163 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 16,n=28,26,22,19,18 | -0.29 Millimoles per liter | Standard Deviation 1.113 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 20,n=25,23,19,18,16 | 0.46 Millimoles per liter | Standard Deviation 1.714 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 4,n=37,38,25,23,27 | 0.2 Millimoles per liter | Standard Deviation 2.29 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 24,n=22,21,16,17,16 | -0.23 Millimoles per liter | Standard Deviation 1.217 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 28,n=19,18,12,13,14 | 0.58 Millimoles per liter | Standard Deviation 1.627 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 32,n=19,15,10,12,13 | 0.72 Millimoles per liter | Standard Deviation 1.795 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 36,n=15,12,10,12,13 | 0.05 Millimoles per liter | Standard Deviation 1.019 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 40,n=15,11,9,10,10 | 0.22 Millimoles per liter | Standard Deviation 1.203 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 8,n=34,31,24,22,23 | 0.1 Millimoles per liter | Standard Deviation 2.32 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 44,n=11,11,6,8,9 | -0.27 Millimoles per liter | Standard Deviation 0.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 48,n=9,8,5,8,5 | -0.62 Millimoles per liter | Standard Deviation 1.441 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 52,n=9,5,5,5,4 | -0.26 Millimoles per liter | Standard Deviation 1.316 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 2,n=38,39,26,24,26 | 0.017 Millimoles per liter | Standard Deviation 0.1886 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 4,n=37,38,25,23,27 | 0.093 Millimoles per liter | Standard Deviation 0.1848 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 12,n=32,28,24,22,21 | 0.6 Millimoles per liter | Standard Deviation 1.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 8,n=34,31,24,22,23 | 0.112 Millimoles per liter | Standard Deviation 0.1588 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 12,n=32,28,24,22,21 | 0.190 Millimoles per liter | Standard Deviation 0.1725 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 16,n=28,26,22,19,18 | 0.146 Millimoles per liter | Standard Deviation 0.1612 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 20,n=25,23,19,18,16 | 0.141 Millimoles per liter | Standard Deviation 0.2257 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 24,n=22,21,16,17,16 | 0.181 Millimoles per liter | Standard Deviation 0.1778 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 16,n=28,26,22,19,18 | -0.2 Millimoles per liter | Standard Deviation 2.25 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 28,n=19,18,12,13,14 | 0.191 Millimoles per liter | Standard Deviation 0.198 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 32,n=19,15,10,12,13 | 0.214 Millimoles per liter | Standard Deviation 0.2086 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 36,n=15,12,10,12,13 | 0.304 Millimoles per liter | Standard Deviation 0.2112 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 40,n=15,11,6,10,10 | 0.104 Millimoles per liter | Standard Deviation 0.1948 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 20,n=25,23,19,18,16 | -0.3 Millimoles per liter | Standard Deviation 2.6 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 4,n=37,38,25,23,27 | -0.10 Millimoles per liter | Standard Deviation 0.453 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 24,n=22,21,16,17,16 | -0.4 Millimoles per liter | Standard Deviation 2 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 28,n=19,18,12,13,14 | 0.5 Millimoles per liter | Standard Deviation 1.93 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 32,n=19,15,10,12,13 | -0.2 Millimoles per liter | Standard Deviation 2.04 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 36,n=15,12,10,12,13 | -0.4 Millimoles per liter | Standard Deviation 2.07 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 40,n=15,11,9,10,10 | -1.2 Millimoles per liter | Standard Deviation 2.49 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 8,n=34,31,24,22,23 | -0.11 Millimoles per liter | Standard Deviation 0.422 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 44,n=11,11,6,8,9 | -2.0 Millimoles per liter | Standard Deviation 2.53 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 48,n=9,8,5,8,5 | -0.6 Millimoles per liter | Standard Deviation 2.07 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 52,n=9,5,5,5,4 | -0.8 Millimoles per liter | Standard Deviation 3.11 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 2,n=38,39,26,24,26 | 0.28 Millimoles per liter | Standard Deviation 1.439 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 4,n=37,38,25,23,27 | -0.06 Millimoles per liter | Standard Deviation 1.277 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 12,n=32,28,24,22,21 | -0.10 Millimoles per liter | Standard Deviation 0.346 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 8,n=34,31,24,22,23 | -0.12 Millimoles per liter | Standard Deviation 1.265 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 12,n=32,28,24,22,21 | -0.62 Millimoles per liter | Standard Deviation 1.501 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 16,n=28,26,22,19,18 | -0.72 Millimoles per liter | Standard Deviation 1.232 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 20,n=25,23,19,18,16 | -0.70 Millimoles per liter | Standard Deviation 1.197 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 24,n=22,21,16,17,16 | -0.80 Millimoles per liter | Standard Deviation 1.717 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 16,n=28,26,22,19,18 | -0.02 Millimoles per liter | Standard Deviation 0.358 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 28,n=19,18,12,13,14 | -0.73 Millimoles per liter | Standard Deviation 1.317 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 32,n=19,15,10,12,13 | -0.83 Millimoles per liter | Standard Deviation 1.382 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 48,n=9,8,5,8,5 | 0.028 Millimoles per liter | Standard Deviation 0.2611 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 36,n=15,12,10,12,13 | -0.93 Millimoles per liter | Standard Deviation 1.113 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 40,n=15,11,9,10,10 | -0.98 Millimoles per liter | Standard Deviation 1.237 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 44,n=11,11,6,8,9 | -0.63 Millimoles per liter | Standard Deviation 1.359 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 20,n=25,23,19,18,16 | 0.02 Millimoles per liter | Standard Deviation 0.417 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 48,n=9,8,5,8,5 | -0.06 Millimoles per liter | Standard Deviation 1.311 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 52,n=9,5,5,5,4 | -0.76 Millimoles per liter | Standard Deviation 1.647 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 2,n=38,39,26,24,26 | -0.008 Millimoles per liter | Standard Deviation 0.0817 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 4,n=37,38,25,23,27 | 0.013 Millimoles per liter | Standard Deviation 0.0649 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 8,n=34,31,24,22,23 | 0.005 Millimoles per liter | Standard Deviation 0.0764 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 24,n=22,21,16,17,16 | -0.13 Millimoles per liter | Standard Deviation 0.368 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 12,n=32,28,24,22,21 | -0.001 Millimoles per liter | Standard Deviation 0.075 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 16,n=28,26,22,19,18 | 0.018 Millimoles per liter | Standard Deviation 0.0954 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 20,n=25,23,19,18,16 | 0.032 Millimoles per liter | Standard Deviation 0.0933 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 24,n=22,21,16,17,16 | 0.032 Millimoles per liter | Standard Deviation 0.1077 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 28,n=19,18,12,13,14 | 0.054 Millimoles per liter | Standard Deviation 0.1232 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 28,n=19,18,12,13,14 | 0.17 Millimoles per liter | Standard Deviation 0.414 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 32,n=19,15,10,12,13 | 0.059 Millimoles per liter | Standard Deviation 0.0737 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 36,n=15,12,10,12,13 | 0.075 Millimoles per liter | Standard Deviation 0.0738 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 40,n=15,11,9,10,10 | 0.008 Millimoles per liter | Standard Deviation 0.093 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 44,n=11,11,6,8,9 | -0.002 Millimoles per liter | Standard Deviation 0.0475 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 48,n=9,8,5,8,5 | -0.018 Millimoles per liter | Standard Deviation 0.0769 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 32,n=19,15,10,12,13 | 0.17 Millimoles per liter | Standard Deviation 0.333 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 52,n=9,5,5,5,4 | 0.026 Millimoles per liter | Standard Deviation 0.0747 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 2,n=38,39,26,24,26 | 0.5 Millimoles per liter | Standard Deviation 2.53 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 4,n=37,38,25,23,27 | 0.4 Millimoles per liter | Standard Deviation 2.69 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 8,n=34,31,24,22,23 | 0.0 Millimoles per liter | Standard Deviation 2.69 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 12,n=32,28,24,22,21 | -0.4 Millimoles per liter | Standard Deviation 2.28 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 36,n=15,12,10,12,13 | 0.18 Millimoles per liter | Standard Deviation 0.408 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 16,n=28,26,22,19,18 | 0.8 Millimoles per liter | Standard Deviation 2.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 20,n=25,23,19,18,16 | -0.1 Millimoles per liter | Standard Deviation 2.7 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 52,n=9,5,5,5,4 | 0.208 Millimoles per liter | Standard Deviation 0.1583 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 24,n=22,21,16,17,16 | -0.8 Millimoles per liter | Standard Deviation 2.65 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 28,n=19,18,12,13,14 | -1.0 Millimoles per liter | Standard Deviation 2.04 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 32,n=19,15,10,12,13 | -1.4 Millimoles per liter | Standard Deviation 2.17 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 40,n=15,11,9,10,10 | 0.01 Millimoles per liter | Standard Deviation 0.276 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 36,n=15,12,10,12,13 | -0.9 Millimoles per liter | Standard Deviation 1.97 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 40,n=15,11,6,10,10 | -1.7 Millimoles per liter | Standard Deviation 2.35 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 44,n=11,11,6,8,9 | 0.0 Millimoles per liter | Standard Deviation 3.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 48,n=9,8,5,8,5 | -1.0 Millimoles per liter | Standard Deviation 2.65 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 52,n=9,5,5,5,4 | -1.2 Millimoles per liter | Standard Deviation 1.48 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 44,n=11,11,6,8,9 | -0.13 Millimoles per liter | Standard Deviation 0.288 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 2,n=38,39,26,24,26 | 0.7 Millimoles per liter | Standard Deviation 1.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 4,n=37,38,25,23,27 | 1.4 Millimoles per liter | Standard Deviation 1.87 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 44,n=11,11,6,8,9 | 0.090 Millimoles per liter | Standard Deviation 0.2131 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 8,n=34,31,24,22,23 | 2.0 Millimoles per liter | Standard Deviation 2.65 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 12,n=32,28,24,22,21 | 2.4 Millimoles per liter | Standard Deviation 2.3 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 16,n=28,26,22,19,18 | 2.2 Millimoles per liter | Standard Deviation 2.46 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 48,n=9,8,5,8,5 | -0.04 Millimoles per liter | Standard Deviation 0.182 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 20,n=25,23,19,18,16 | 2.1 Millimoles per liter | Standard Deviation 2.49 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 24,n=22,21,16,17,16 | 1.6 Millimoles per liter | Standard Deviation 3.16 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 28,n=19,18,12,13,14 | 2.8 Millimoles per liter | Standard Deviation 2.49 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 32,n=19,15,10,12,13 | 2.0 Millimoles per liter | Standard Deviation 2.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 36,n=15,12,10,12,13 | 1.9 Millimoles per liter | Standard Deviation 2.47 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 52,n=9,5,5,5,4 | -0.10 Millimoles per liter | Standard Deviation 0.418 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 40,n=15,11,9,10,10 | 1.4 Millimoles per liter | Standard Deviation 1.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 44,n=11,11,6,8,9 | 0.2 Millimoles per liter | Standard Deviation 2.14 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 48,n=9,8,5,8,5 | 2.0 Millimoles per liter | Standard Deviation 1.58 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 52,n=9,5,5,5,4 | 0.2 Millimoles per liter | Standard Deviation 3.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 2,n=38,39,26,24,26 | 0.01 Millimoles per liter | Standard Deviation 1.237 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 2,n=38,39,26,24,26 | -0.8 Millimoles per liter | Standard Deviation 2.37 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 4,n=37,38,25,23,27 | 0.38 Millimoles per liter | Standard Deviation 1.601 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 20,n=25,23,19,18,16 | 0.10 Millimoles per liter | Standard Deviation 0.287 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 48,n=9,8,5,8,5 | -0.51 Millimoles per liter | Standard Deviation 1.225 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 52,n=9,5,5,5,4 | 0.06 Millimoles per liter | Standard Deviation 0.445 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 32,n=19,15,10,12,13 | -0.6 Millimoles per liter | Standard Deviation 2.43 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 44,n=11,11,6,8,9 | -0.065 Millimoles per liter | Standard Deviation 0.2267 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 44,n=11,11,6,8,9 | -0.76 Millimoles per liter | Standard Deviation 1.274 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 40,n=15,11,9,10,10 | -0.76 Millimoles per liter | Standard Deviation 1.552 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 48,n=9,8,5,8,5 | -0.88 Millimoles per liter | Standard Deviation 1.369 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 36,n=15,12,10,12,13 | -0.3 Millimoles per liter | Standard Deviation 3.63 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 40,n=15,11,9,10,10 | 0.03 Millimoles per liter | Standard Deviation 0.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 36,n=15,12,10,12,13 | -0.01 Millimoles per liter | Standard Deviation 0.973 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 32,n=19,15,10,12,13 | -0.76 Millimoles per liter | Standard Deviation 1.071 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 16,n=28,26,22,19,18 | -0.12 Millimoles per liter | Standard Deviation 1.414 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 40,n=15,11,6,10,10 | -0.8 Millimoles per liter | Standard Deviation 2.7 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 52,n=9,5,5,5,4 | 0.036 Millimoles per liter | Standard Deviation 0.0865 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 16,n=28,26,22,19,18 | 0.15 Millimoles per liter | Standard Deviation 0.345 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 28,n=19,18,12,13,14 | 0.23 Millimoles per liter | Standard Deviation 1.111 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 44,n=11,11,6,8,9 | 1.1 Millimoles per liter | Standard Deviation 2.03 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 44,n=11,11,6,8,9 | -1.6 Millimoles per liter | Standard Deviation 1.6 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 24,n=22,21,16,17,16 | -0.65 Millimoles per liter | Standard Deviation 1.457 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 20,n=25,23,19,18,16 | -0.31 Millimoles per liter | Standard Deviation 1.47 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 16,n=28,26,22,19,18 | -0.40 Millimoles per liter | Standard Deviation 1.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 8,n=34,31,24,22,23 | 0.5 Millimoles per liter | Standard Deviation 1.5 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 48,n=9,8,5,8,5 | 0.0 Millimoles per liter | Standard Deviation 1.77 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 12,n=32,28,24,22,21 | -1.12 Millimoles per liter | Standard Deviation 1.457 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 12,n=32,28,24,22,21 | 0.06 Millimoles per liter | Standard Deviation 0.336 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 8,n=34,31,24,22,23 | -0.91 Millimoles per liter | Standard Deviation 0.97 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 44,n=11,11,6,8,9 | 0.30 Millimoles per liter | Standard Deviation 0.739 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 52,n=9,5,5,5,4 | -0.4 Millimoles per liter | Standard Deviation 1.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 40,n=15,11,9,10,10 | -0.22 Millimoles per liter | Standard Deviation 1.192 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 4,n=37,38,25,23,27 | -0.22 Millimoles per liter | Standard Deviation 1.022 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 2,n=38,39,26,24,26 | -0.31 Millimoles per liter | Standard Deviation 1.458 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 8,n=34,31,24,22,23 | 0.10 Millimoles per liter | Standard Deviation 1.579 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 2,n=38,39,26,24,26 | 1.0 Millimoles per liter | Standard Deviation 2.16 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 44,n=11,11,6,8,9 | 0.15 Millimoles per liter | Standard Deviation 0.385 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 52,n=9,5,5,5,4 | 1.6 Millimoles per liter | Standard Deviation 1.14 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 48,n=9,8,5,8,5 | 0.3 Millimoles per liter | Standard Deviation 1.91 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 48,n=9,8,5,8,5 | 1.8 Millimoles per liter | Standard Deviation 1.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 4,n=37,38,25,23,27 | 0.7 Millimoles per liter | Standard Deviation 2.14 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 36,n=15,12,10,12,13 | -0.50 Millimoles per liter | Standard Deviation 1.261 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 8,n=34,31,24,22,23 | 0.10 Millimoles per liter | Standard Deviation 0.333 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 44,n=11,11,6,8,9 | -0.8 Millimoles per liter | Standard Deviation 1.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 32,n=19,15,10,12,13 | -0.05 Millimoles per liter | Standard Deviation 1.363 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 8,n=34,31,24,22,23 | 1.0 Millimoles per liter | Standard Deviation 2.18 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 40,n=15,11,9,10,10 | 0.5 Millimoles per liter | Standard Deviation 1.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 36,n=15,12,10,12,13 | -0.2 Millimoles per liter | Standard Deviation 1.85 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 32,n=19,15,10,12,13 | -0.8 Millimoles per liter | Standard Deviation 3.16 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 2,n=38,39,26,24,26 | 0.18 Millimoles per liter | Standard Deviation 0.336 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 12,n=32,28,24,22,21 | 0.6 Millimoles per liter | Standard Deviation 2.06 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 28,n=19,18,12,13,14 | -0.8 Millimoles per liter | Standard Deviation 3.22 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 4,n=37,38,25,23,27 | 0.06 Millimoles per liter | Standard Deviation 0.329 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 24,n=22,21,16,17,16 | 0.4 Millimoles per liter | Standard Deviation 1.5 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 4,n=37,38,25,23,27 | 0.31 Millimoles per liter | Standard Deviation 1.466 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 16,n=28,26,22,19,18 | 1.1 Millimoles per liter | Standard Deviation 2.04 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 52,n=9,5,5,5,4 | 3.6 Millimoles per liter | Standard Deviation 1.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 20,n=25,23,19,18,16 | -0.6 Millimoles per liter | Standard Deviation 0.92 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 40,n=15,11,6,10,10 | 0.073 Millimoles per liter | Standard Deviation 0.1849 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 28,n=19,18,12,13,14 | -0.25 Millimoles per liter | Standard Deviation 1.278 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 20,n=25,23,19,18,16 | 1.3 Millimoles per liter | Standard Deviation 2.22 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 48,n=9,8,5,8,5 | 0.16 Millimoles per liter | Standard Deviation 0.283 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 36,n=15,12,10,12,13 | 0.098 Millimoles per liter | Standard Deviation 0.1939 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 32,n=19,15,10,12,13 | 0.048 Millimoles per liter | Standard Deviation 0.1677 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 4,n=37,38,25,23,27 | 0.0 Millimoles per liter | Standard Deviation 1.43 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 24,n=22,21,16,17,16 | 1.0 Millimoles per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 16,n=28,26,22,19,18 | -0.3 Millimoles per liter | Standard Deviation 1.37 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 28,n=19,18,12,13,14 | 0.073 Millimoles per liter | Standard Deviation 0.2017 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 24,n=22,21,16,17,16 | 0.055 Millimoles per liter | Standard Deviation 0.1728 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 24,n=22,21,16,17,16 | -0.38 Millimoles per liter | Standard Deviation 1.29 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 28,n=19,18,12,13,14 | 0.2 Millimoles per liter | Standard Deviation 3.49 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 20,n=25,23,19,18,16 | 0.043 Millimoles per liter | Standard Deviation 0.1854 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 16,n=28,26,22,19,18 | 0.025 Millimoles per liter | Standard Deviation 0.1589 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 12,n=32,28,24,22,21 | 0.067 Millimoles per liter | Standard Deviation 0.1873 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 2,n=38,39,26,24,26 | -0.2 Millimoles per liter | Standard Deviation 1.52 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 32,n=19,15,10,12,13 | -0.1 Millimoles per liter | Standard Deviation 4.17 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 12,n=32,28,24,22,21 | 0.5 Millimoles per liter | Standard Deviation 1.79 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 2,n=38,39,26,24,26 | -0.3 Millimoles per liter | Standard Deviation 2.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 32,n=19,15,10,12,13 | 0.19 Millimoles per liter | Standard Deviation 0.365 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 52,n=9,5,5,5,4 | -0.056 Millimoles per liter | Standard Deviation 0.1161 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 48,n=9,8,5,8,5 | -0.035 Millimoles per liter | Standard Deviation 0.0769 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 8,n=34,31,24,22,23 | 0.045 Millimoles per liter | Standard Deviation 0.1971 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 4,n=37,38,25,23,27 | 0.2 Millimoles per liter | Standard Deviation 1.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 44,n=11,11,6,8,9 | -0.035 Millimoles per liter | Standard Deviation 0.1638 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 40,n=15,11,9,10,10 | -0.042 Millimoles per liter | Standard Deviation 0.0561 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 36,n=15,12,10,12,13 | -0.038 Millimoles per liter | Standard Deviation 0.1025 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 4,n=37,38,25,23,27 | 0.006 Millimoles per liter | Standard Deviation 0.1883 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 8,n=34,31,24,22,23 | 0.0 Millimoles per liter | Standard Deviation 2.01 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 32,n=19,15,10,12,13 | -0.008 Millimoles per liter | Standard Deviation 0.0978 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 28,n=19,18,12,13,14 | 0.08 Millimoles per liter | Standard Deviation 0.297 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 28,n=19,18,12,13,14 | 0.018 Millimoles per liter | Standard Deviation 0.0838 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 2,n=38,39,26,24,26 | 0.29 Millimoles per liter | Standard Deviation 1.358 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 12,n=32,28,24,22,21 | 0.0 Millimoles per liter | Standard Deviation 1.94 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 36,n=15,12,10,12,13 | 1.1 Millimoles per liter | Standard Deviation 1.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 24,n=22,21,16,17,16 | -0.002 Millimoles per liter | Standard Deviation 0.0748 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 20,n=25,23,19,18,16 | 0.000 Millimoles per liter | Standard Deviation 0.0884 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 12,n=32,28,24,22,21 | -0.25 Millimoles per liter | Standard Deviation 1.164 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 16,n=28,26,22,19,18 | -0.1 Millimoles per liter | Standard Deviation 1.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 36,n=15,12,10,12,13 | 0.18 Millimoles per liter | Standard Deviation 0.341 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 16,n=28,26,22,19,18 | -0.008 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 24,n=22,21,16,17,16 | 0.15 Millimoles per liter | Standard Deviation 0.371 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 2,n=38,39,26,24,26 | -0.025 Millimoles per liter | Standard Deviation 0.1622 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 20,n=25,23,19,18,16 | -0.3 Millimoles per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 52,n=9,5,5,5,4 | -0.72 Millimoles per liter | Standard Deviation 1.308 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 12,n=32,28,24,22,21 | 0.011 Millimoles per liter | Standard Deviation 0.0913 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 8,n=34,31,24,22,23 | 0.020 Millimoles per liter | Standard Deviation 0.0918 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 20,n=25,23,19,18,16 | -0.33 Millimoles per liter | Standard Deviation 1.435 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 24,n=22,21,16,17,16 | 0.5 Millimoles per liter | Standard Deviation 2.29 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 4,n=37,38,25,23,27 | -0.016 Millimoles per liter | Standard Deviation 0.0922 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 2,n=38,39,26,24,26 | 0.008 Millimoles per liter | Standard Deviation 0.105 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 48,n=9,8,5,8,5 | -0.015 Millimoles per liter | Standard Deviation 0.1561 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 40,n=15,11,9,10,10 | 1.9 Millimoles per liter | Standard Deviation 1.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 28,n=19,18,12,13,14 | -0.4 Millimoles per liter | Standard Deviation 2.36 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 52,n=9,5,5,5,4 | -0.82 Millimoles per liter | Standard Deviation 0.782 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 40,n=15,11,6,10,10 | 0.4 Millimoles per liter | Standard Deviation 1.43 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 44,n=11,11,6,8,9 | 0.218 Millimoles per liter | Standard Deviation 0.2184 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 48,n=9,8,5,8,5 | 0.132 Millimoles per liter | Standard Deviation 0.1972 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 52,n=9,5,5,5,4 | 0.115 Millimoles per liter | Standard Deviation 0.1434 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 2,n=38,39,26,24,26 | 0.08 Millimoles per liter | Standard Deviation 0.375 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 4,n=37,38,25,23,27 | -0.03 Millimoles per liter | Standard Deviation 0.343 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 8,n=34,31,24,22,23 | 0.06 Millimoles per liter | Standard Deviation 0.399 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 12,n=32,28,24,22,21 | 0.04 Millimoles per liter | Standard Deviation 0.446 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 16,n=28,26,22,19,18 | 0.15 Millimoles per liter | Standard Deviation 0.279 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 20,n=25,23,19,18,16 | 0.16 Millimoles per liter | Standard Deviation 0.39 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 24,n=22,21,16,17,16 | 0.16 Millimoles per liter | Standard Deviation 0.411 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 28,n=19,18,12,13,14 | 0.23 Millimoles per liter | Standard Deviation 0.418 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 32,n=19,15,10,12,13 | 0.25 Millimoles per liter | Standard Deviation 0.443 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 36,n=15,12,10,12,13 | 0.21 Millimoles per liter | Standard Deviation 0.403 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 40,n=15,11,9,10,10 | 0.28 Millimoles per liter | Standard Deviation 0.355 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 44,n=11,11,6,8,9 | 0.16 Millimoles per liter | Standard Deviation 0.488 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 48,n=9,8,5,8,5 | 0.52 Millimoles per liter | Standard Deviation 0.432 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Potassium,Week 52,n=9,5,5,5,4 | 0.20 Millimoles per liter | Standard Deviation 0.365 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 2,n=38,39,26,24,26 | 0.9 Millimoles per liter | Standard Deviation 2.92 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 4,n=37,38,25,23,27 | 0.6 Millimoles per liter | Standard Deviation 2.65 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 8,n=34,31,24,22,23 | 1.7 Millimoles per liter | Standard Deviation 2.91 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 12,n=32,28,24,22,21 | 2.1 Millimoles per liter | Standard Deviation 2.37 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 16,n=28,26,22,19,18 | 2.3 Millimoles per liter | Standard Deviation 3.59 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 20,n=25,23,19,18,16 | 2.3 Millimoles per liter | Standard Deviation 3.52 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 24,n=22,21,16,17,16 | 1.9 Millimoles per liter | Standard Deviation 2.96 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 28,n=19,18,12,13,14 | 2.4 Millimoles per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 32,n=19,15,10,12,13 | 3.2 Millimoles per liter | Standard Deviation 4.13 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 36,n=15,12,10,12,13 | 2.8 Millimoles per liter | Standard Deviation 3.6 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 40,n=15,11,9,10,10 | 2.9 Millimoles per liter | Standard Deviation 3.07 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 44,n=11,11,6,8,9 | 1.8 Millimoles per liter | Standard Deviation 3.77 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 48,n=9,8,5,8,5 | 1.6 Millimoles per liter | Standard Deviation 2.7 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Sodium,Week 52,n=9,5,5,5,4 | 3.5 Millimoles per liter | Standard Deviation 3.32 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 2,n=38,39,26,24,26 | -0.32 Millimoles per liter | Standard Deviation 1.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 4,n=37,38,25,23,27 | -0.27 Millimoles per liter | Standard Deviation 1.7 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 8,n=34,31,24,22,23 | -0.34 Millimoles per liter | Standard Deviation 0.965 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 12,n=32,28,24,22,21 | -0.35 Millimoles per liter | Standard Deviation 1.316 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 16,n=28,26,22,19,18 | -0.07 Millimoles per liter | Standard Deviation 1.701 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 20,n=25,23,19,18,16 | -0.77 Millimoles per liter | Standard Deviation 1.9 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 24,n=22,21,16,17,16 | -0.64 Millimoles per liter | Standard Deviation 2.019 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 28,n=19,18,12,13,14 | -0.31 Millimoles per liter | Standard Deviation 1.495 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 32,n=19,15,10,12,13 | 0.17 Millimoles per liter | Standard Deviation 2.609 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 36,n=15,12,10,12,13 | -0.22 Millimoles per liter | Standard Deviation 2.297 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 40,n=15,11,9,10,10 | 0.32 Millimoles per liter | Standard Deviation 1.886 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 44,n=11,11,6,8,9 | -1.09 Millimoles per liter | Standard Deviation 1.727 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 48,n=9,8,5,8,5 | 0.44 Millimoles per liter | Standard Deviation 1.282 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Urea,Week 52,n=9,5,5,5,4 | -0.45 Millimoles per liter | Standard Deviation 1.475 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 2,n=38,39,26,24,26 | 0.013 Millimoles per liter | Standard Deviation 0.0812 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 4,n=37,38,25,23,27 | -0.001 Millimoles per liter | Standard Deviation 0.0899 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 8,n=34,31,24,22,23 | 0.013 Millimoles per liter | Standard Deviation 0.0615 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 12,n=32,28,24,22,21 | 0.016 Millimoles per liter | Standard Deviation 0.0851 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 16,n=28,26,22,19,18 | 0.044 Millimoles per liter | Standard Deviation 0.0768 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 20,n=25,23,19,18,16 | 0.012 Millimoles per liter | Standard Deviation 0.0932 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 24,n=22,21,16,17,16 | 0.009 Millimoles per liter | Standard Deviation 0.0702 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 28,n=19,18,12,13,14 | 0.076 Millimoles per liter | Standard Deviation 0.1108 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 36,n=15,12,10,12,13 | 0.053 Millimoles per liter | Standard Deviation 0.0957 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 32,n=19,15,10,12,13 | 0.075 Millimoles per liter | Standard Deviation 0.1271 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 40,n=15,11,9,10,10 | 0.037 Millimoles per liter | Standard Deviation 0.0589 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 44,n=11,11,6,8,9 | 0.054 Millimoles per liter | Standard Deviation 0.1146 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 48,n=9,8,5,8,5 | 0.142 Millimoles per liter | Standard Deviation 0.0782 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | calcium,Week 52,n=9,5,5,5,4 | 0.083 Millimoles per liter | Standard Deviation 0.0624 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 2,n=38,39,26,24,26 | 0.7 Millimoles per liter | Standard Deviation 2.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 4,n=37,38,25,23,27 | 0.1 Millimoles per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 8,n=34,31,24,22,23 | 1.1 Millimoles per liter | Standard Deviation 2.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 12,n=32,28,24,22,21 | 1.2 Millimoles per liter | Standard Deviation 1.73 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 16,n=28,26,22,19,18 | 0.5 Millimoles per liter | Standard Deviation 2.55 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 20,n=25,23,19,18,16 | 0.5 Millimoles per liter | Standard Deviation 2.68 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 24,n=22,21,16,17,16 | -0.2 Millimoles per liter | Standard Deviation 2.61 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 28,n=19,18,12,13,14 | 0.4 Millimoles per liter | Standard Deviation 3.08 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 32,n=19,15,10,12,13 | 0.2 Millimoles per liter | Standard Deviation 2.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 36,n=15,12,10,12,13 | 1.0 Millimoles per liter | Standard Deviation 2.16 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 40,n=15,11,6,10,10 | 0.206 Millimoles per liter | Standard Deviation 0.2151 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 44,n=11,11,6,8,9 | -0.1 Millimoles per liter | Standard Deviation 2.47 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 48,n=9,8,5,8,5 | -0.2 Millimoles per liter | Standard Deviation 2.17 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Carbon Dioxide,Week 52,n=9,5,5,5,4 | 1.8 Millimoles per liter | Standard Deviation 2.87 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 2,n=38,39,26,24,26 | 0.8 Millimoles per liter | Standard Deviation 2.77 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 4,n=37,38,25,23,27 | 1.4 Millimoles per liter | Standard Deviation 2.79 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 8,n=34,31,24,22,23 | 2.1 Millimoles per liter | Standard Deviation 3.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 12,n=32,28,24,22,21 | 2.0 Millimoles per liter | Standard Deviation 2.36 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 16,n=28,26,22,19,18 | 2.4 Millimoles per liter | Standard Deviation 3.4 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 20,n=25,23,19,18,16 | 2.5 Millimoles per liter | Standard Deviation 3.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 24,n=22,21,16,17,16 | 2.3 Millimoles per liter | Standard Deviation 3.55 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 28,n=19,18,12,13,14 | 2.9 Millimoles per liter | Standard Deviation 3.63 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 32,n=19,15,10,12,13 | 3.4 Millimoles per liter | Standard Deviation 3.43 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 36,n=15,12,10,12,13 | 2.8 Millimoles per liter | Standard Deviation 3.37 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 40,n=15,11,9,10,10 | 3.9 Millimoles per liter | Standard Deviation 3.03 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 44,n=11,11,6,8,9 | 2.2 Millimoles per liter | Standard Deviation 4.52 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 48,n=9,8,5,8,5 | 2.8 Millimoles per liter | Standard Deviation 3.11 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Chloride,Week 52,n=9,5,5,5,4 | 3.8 Millimoles per liter | Standard Deviation 4.11 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 2,n=38,39,26,24,26 | -0.44 Millimoles per liter | Standard Deviation 3.578 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 4,n=37,38,25,23,27 | -0.03 Millimoles per liter | Standard Deviation 4.387 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 8,n=34,31,24,22,23 | -1.15 Millimoles per liter | Standard Deviation 5.685 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 12,n=32,28,24,22,21 | -1.76 Millimoles per liter | Standard Deviation 5.919 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 16,n=28,26,22,19,18 | -1.15 Millimoles per liter | Standard Deviation 6.411 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 20,n=25,23,19,18,16 | -1.96 Millimoles per liter | Standard Deviation 7.018 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 24,n=22,21,16,17,16 | -2.08 Millimoles per liter | Standard Deviation 6.953 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 28,n=19,18,12,13,14 | -2.05 Millimoles per liter | Standard Deviation 7.699 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 32,n=19,15,10,12,13 | -3.12 Millimoles per liter | Standard Deviation 7.818 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 36,n=15,12,10,12,13 | -2.98 Millimoles per liter | Standard Deviation 7.786 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 40,n=15,11,9,10,10 | -0.94 Millimoles per liter | Standard Deviation 3.589 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 44,n=11,11,6,8,9 | -0.23 Millimoles per liter | Standard Deviation 2.001 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 48,n=9,8,5,8,5 | -0.36 Millimoles per liter | Standard Deviation 2.196 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Glucose,Week 52,n=9,5,5,5,4 | 0.45 Millimoles per liter | Standard Deviation 2.353 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 2,n=38,39,26,24,26 | 0.005 Millimoles per liter | Standard Deviation 0.1601 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 4,n=37,38,25,23,27 | 0.008 Millimoles per liter | Standard Deviation 0.2087 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 8,n=34,31,24,22,23 | 0.055 Millimoles per liter | Standard Deviation 0.1746 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 12,n=32,28,24,22,21 | 0.079 Millimoles per liter | Standard Deviation 0.1946 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 16,n=28,26,22,19,18 | 0.039 Millimoles per liter | Standard Deviation 0.2238 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 20,n=25,23,19,18,16 | 0.060 Millimoles per liter | Standard Deviation 0.2183 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 24,n=22,21,16,17,16 | 0.101 Millimoles per liter | Standard Deviation 0.1811 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 28,n=19,18,12,13,14 | 0.190 Millimoles per liter | Standard Deviation 0.3143 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 32,n=19,15,10,12,13 | 0.155 Millimoles per liter | Standard Deviation 0.2713 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea | Phosphate,Week 36,n=15,12,10,12,13 | 0.151 Millimoles per liter | Standard Deviation 0.2114 |
Secondary
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 2,n=37,39,26,24,26 | -13.05 Millimeters per hour | Standard Deviation 9.885 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 32,n=19,15,10,12,13 | -13.26 Millimeters per hour | Standard Deviation 17.486 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 24,n=23,19,16,17,16 | -13.63 Millimeters per hour | Standard Deviation 11.209 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 28,n=19,18,11,14,14 | -15.26 Millimeters per hour | Standard Deviation 12.274 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 48,n=9,8,5,8,5 | -15.33 Millimeters per hour | Standard Deviation 11.822 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 8,n=33,31,24,22,23 | -14.21 Millimeters per hour | Standard Deviation 9.927 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 44,n=11,11,6,8,8 | -12.64 Millimeters per hour | Standard Deviation 10.347 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 12,n=32,28,24,22,22 | -14.97 Millimeters per hour | Standard Deviation 11.361 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 52,n=9,5,5,5,4 | -14.78 Millimeters per hour | Standard Deviation 11.692 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 40,n=15,11,9,10,10 | -14.40 Millimeters per hour | Standard Deviation 12.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 16,n=28,26,22,19,19 | -12.50 Millimeters per hour | Standard Deviation 10.469 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 4,n=36,38,25,22,27 | -12.83 Millimeters per hour | Standard Deviation 9.346 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 36,n=15,12,10,12, 13 | -14.47 Millimeters per hour | Standard Deviation 11.673 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 20,n=26,23,18,18,16 | -13.19 Millimeters per hour | Standard Deviation 9.6 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 20,n=26,23,18,18,16 | -17.07 Millimeters per hour | Standard Deviation 18.498 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 16,n=28,26,22,19,19 | -17.17 Millimeters per hour | Standard Deviation 17.693 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 12,n=32,28,24,22,22 | -17.89 Millimeters per hour | Standard Deviation 17.846 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 24,n=23,19,16,17,16 | -16.84 Millimeters per hour | Standard Deviation 15.378 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 4,n=36,38,25,22,27 | -17.41 Millimeters per hour | Standard Deviation 15.867 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 28,n=19,18,11,14,14 | -19.94 Millimeters per hour | Standard Deviation 20.069 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 32,n=19,15,10,12,13 | -19.80 Millimeters per hour | Standard Deviation 19.266 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 2,n=37,39,26,24,26 | -12.78 Millimeters per hour | Standard Deviation 15.56 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 48,n=9,8,5,8,5 | -25.63 Millimeters per hour | Standard Deviation 24.372 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 40,n=15,11,9,10,10 | -22.27 Millimeters per hour | Standard Deviation 21.873 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 36,n=15,12,10,12, 13 | -21.25 Millimeters per hour | Standard Deviation 20.855 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 8,n=33,31,24,22,23 | -18.76 Millimeters per hour | Standard Deviation 17.727 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 52,n=9,5,5,5,4 | -24.60 Millimeters per hour | Standard Deviation 17.7 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 44,n=11,11,6,8,8 | -22.18 Millimeters per hour | Standard Deviation 21.409 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 20,n=26,23,18,18,16 | -14.33 Millimeters per hour | Standard Deviation 15.442 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 2,n=37,39,26,24,26 | -14.62 Millimeters per hour | Standard Deviation 16.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 4,n=36,38,25,22,27 | -14.13 Millimeters per hour | Standard Deviation 12.419 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 8,n=33,31,24,22,23 | -15.05 Millimeters per hour | Standard Deviation 14.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 12,n=32,28,24,22,22 | -14.30 Millimeters per hour | Standard Deviation 13.271 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 16,n=28,26,22,19,19 | -15.37 Millimeters per hour | Standard Deviation 13.956 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 24,n=23,19,16,17,16 | -14.89 Millimeters per hour | Standard Deviation 14.504 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 28,n=19,18,11,14,14 | -16.84 Millimeters per hour | Standard Deviation 16.856 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 32,n=19,15,10,12,13 | -14.52 Millimeters per hour | Standard Deviation 13.63 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 36,n=15,12,10,12, 13 | -14.42 Millimeters per hour | Standard Deviation 13.482 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 40,n=15,11,9,10,10 | -11.24 Millimeters per hour | Standard Deviation 13.277 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 44,n=11,11,6,8,8 | -12.00 Millimeters per hour | Standard Deviation 13.52 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 48,n=9,8,5,8,5 | -14.00 Millimeters per hour | Standard Deviation 14.335 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 52,n=9,5,5,5,4 | -12.80 Millimeters per hour | Standard Deviation 15.385 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 20,n=26,23,18,18,16 | 10.00 Millimeters per hour | Standard Deviation 22.141 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 32,n=19,15,10,12,13 | -2.42 Millimeters per hour | Standard Deviation 20.129 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 16,n=28,26,22,19,19 | 14.21 Millimeters per hour | Standard Deviation 25.189 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 36,n=15,12,10,12, 13 | 0.67 Millimeters per hour | Standard Deviation 19.009 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 12,n=32,28,24,22,22 | 20.36 Millimeters per hour | Standard Deviation 18.017 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 2,n=37,39,26,24,26 | -1.33 Millimeters per hour | Standard Deviation 9.323 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 40,n=15,11,9,10,10 | 9.80 Millimeters per hour | Standard Deviation 28.84 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 8,n=33,31,24,22,23 | 6.41 Millimeters per hour | Standard Deviation 12.105 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 44,n=11,11,6,8,8 | 4.88 Millimeters per hour | Standard Deviation 18.256 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 4,n=36,38,25,22,27 | 7.59 Millimeters per hour | Standard Deviation 15.308 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 52,n=9,5,5,5,4 | -4.60 Millimeters per hour | Standard Deviation 10.431 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 24,n=23,19,16,17,16 | 7.59 Millimeters per hour | Standard Deviation 21.567 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 48,n=9,8,5,8,5 | 4.50 Millimeters per hour | Standard Deviation 24.308 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 28,n=19,18,11,14,14 | 1.50 Millimeters per hour | Standard Deviation 15.854 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 24,n=23,19,16,17,16 | -3.06 Millimeters per hour | Standard Deviation 22.389 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 52,n=9,5,5,5,4 | 1.25 Millimeters per hour | Standard Deviation 15.042 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 32,n=19,15,10,12,13 | -2.85 Millimeters per hour | Standard Deviation 29.493 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 16,n=28,26,22,19,19 | -2.53 Millimeters per hour | Standard Deviation 20.839 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 28,n=19,18,11,14,14 | -1.71 Millimeters per hour | Standard Deviation 29.148 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 2,n=37,39,26,24,26 | -9.96 Millimeters per hour | Standard Deviation 20.142 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 44,n=11,11,6,8,8 | 2.88 Millimeters per hour | Standard Deviation 21.86 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 36,n=15,12,10,12, 13 | 0.92 Millimeters per hour | Standard Deviation 28.324 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 12,n=32,28,24,22,22 | -2.55 Millimeters per hour | Standard Deviation 21.498 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 4,n=36,38,25,22,27 | -5.30 Millimeters per hour | Standard Deviation 22.25 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 20,n=26,23,18,18,16 | -5.81 Millimeters per hour | Standard Deviation 23.063 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 48,n=9,8,5,8,5 | 8.60 Millimeters per hour | Standard Deviation 25.205 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 40,n=15,11,9,10,10 | -2.60 Millimeters per hour | Standard Deviation 27.818 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time | Week 8,n=33,31,24,22,23 | 1.78 Millimeters per hour | Standard Deviation 27.361 |
Secondary
Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time
Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.
Time frame: Baseline (Week 0) and up to 52 weeks
Population: Safety Population. Data was not collected due to early termination of the study
Secondary
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 24,n=22,21,16,16,16 | -0.09 trillion cells per liter | Standard Deviation 0.27 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 44,n=11,10,6,7,9 | -0.18 trillion cells per liter | Standard Deviation 0.286 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 12,n=31,28,23,22,22 | 0.03 trillion cells per liter | Standard Deviation 0.255 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 32,n=19,15,10,12,13 | -0.13 trillion cells per liter | Standard Deviation 0.292 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 48,n=9,8,4,8,5 | -0.14 trillion cells per liter | Standard Deviation 0.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 8,n=34,29,23,22,21 | 0.04 trillion cells per liter | Standard Deviation 0.249 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 40,n=14,11,8,10,10 | -0.16 trillion cells per liter | Standard Deviation 0.234 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 16,n=27,26,21,19,19 | -0.09 trillion cells per liter | Standard Deviation 0.238 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 28,n=18,18,12,14,13 | -0.14 trillion cells per liter | Standard Deviation 0.295 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 52,n=8,5,5,5,4 | -0.16 trillion cells per liter | Standard Deviation 0.283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 2,n=38,39,24,24,25 | 0.01 trillion cells per liter | Standard Deviation 0.232 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 36,n=15,12,10,12,12 | -0.08 trillion cells per liter | Standard Deviation 0.262 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 20,n=25,23,18,18,16 | -0.13 trillion cells per liter | Standard Deviation 0.263 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 4,n=36,37,24,22,27 | 0.01 trillion cells per liter | Standard Deviation 0.208 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 20,n=25,23,18,18,16 | -0.03 trillion cells per liter | Standard Deviation 0.305 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 32,n=19,15,10,12,13 | -0.09 trillion cells per liter | Standard Deviation 0.259 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 24,n=22,21,16,16,16 | -0.06 trillion cells per liter | Standard Deviation 0.282 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 4,n=36,37,24,22,27 | -0.01 trillion cells per liter | Standard Deviation 0.311 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 28,n=18,18,12,14,13 | -0.04 trillion cells per liter | Standard Deviation 0.327 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 2,n=38,39,24,24,25 | 0.02 trillion cells per liter | Standard Deviation 0.265 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 48,n=9,8,4,8,5 | -0.23 trillion cells per liter | Standard Deviation 0.266 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 8,n=34,29,23,22,21 | -0.04 trillion cells per liter | Standard Deviation 0.406 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 44,n=11,10,6,7,9 | -0.10 trillion cells per liter | Standard Deviation 0.333 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 12,n=31,28,23,22,22 | 0.05 trillion cells per liter | Standard Deviation 0.417 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 52,n=8,5,5,5,4 | -0.18 trillion cells per liter | Standard Deviation 0.37 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 40,n=14,11,8,10,10 | -0.16 trillion cells per liter | Standard Deviation 0.38 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 16,n=27,26,21,19,19 | -0.07 trillion cells per liter | Standard Deviation 0.312 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 36,n=15,12,10,12,12 | -0.04 trillion cells per liter | Standard Deviation 0.378 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 40,n=14,11,8,10,10 | -0.09 trillion cells per liter | Standard Deviation 0.189 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 2,n=38,39,24,24,25 | -0.01 trillion cells per liter | Standard Deviation 0.303 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 4,n=36,37,24,22,27 | -0.01 trillion cells per liter | Standard Deviation 0.202 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 8,n=34,29,23,22,21 | -0.08 trillion cells per liter | Standard Deviation 0.3 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 12,n=31,28,23,22,22 | -0.07 trillion cells per liter | Standard Deviation 0.265 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 16,n=27,26,21,19,19 | -0.14 trillion cells per liter | Standard Deviation 0.282 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 20,n=25,23,18,18,16 | -0.12 trillion cells per liter | Standard Deviation 0.183 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 24,n=22,21,16,16,16 | -0.04 trillion cells per liter | Standard Deviation 0.234 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 28,n=18,18,12,14,13 | -0.16 trillion cells per liter | Standard Deviation 0.231 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 32,n=19,15,10,12,13 | -0.13 trillion cells per liter | Standard Deviation 0.33 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 36,n=15,12,10,12,12 | -0.10 trillion cells per liter | Standard Deviation 0.183 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 44,n=11,10,6,7,9 | -0.17 trillion cells per liter | Standard Deviation 0.32 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 48,n=9,8,4,8,5 | -0.18 trillion cells per liter | Standard Deviation 0.457 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 52,n=8,5,5,5,4 | -0.02 trillion cells per liter | Standard Deviation 0.531 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 36,n=15,12,10,12,12 | -0.21 trillion cells per liter | Standard Deviation 0.358 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 8,n=34,29,23,22,21 | -0.16 trillion cells per liter | Standard Deviation 0.372 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 32,n=19,15,10,12,13 | -0.22 trillion cells per liter | Standard Deviation 0.321 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 16,n=27,26,21,19,19 | -0.19 trillion cells per liter | Standard Deviation 0.399 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 12,n=31,28,23,22,22 | -0.20 trillion cells per liter | Standard Deviation 0.379 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 4,n=36,37,24,22,27 | -0.09 trillion cells per liter | Standard Deviation 0.268 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 52,n=8,5,5,5,4 | -0.18 trillion cells per liter | Standard Deviation 0.192 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 48,n=9,8,4,8,5 | -0.20 trillion cells per liter | Standard Deviation 0.251 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 44,n=11,10,6,7,9 | -0.10 trillion cells per liter | Standard Deviation 0.216 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 24,n=22,21,16,16,16 | -0.11 trillion cells per liter | Standard Deviation 0.464 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 40,n=14,11,8,10,10 | -0.22 trillion cells per liter | Standard Deviation 0.301 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 28,n=18,18,12,14,13 | -0.18 trillion cells per liter | Standard Deviation 0.377 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 2,n=38,39,24,24,25 | -0.10 trillion cells per liter | Standard Deviation 0.254 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 20,n=25,23,18,18,16 | -0.20 trillion cells per liter | Standard Deviation 0.461 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 20,n=25,23,18,18,16 | -0.08 trillion cells per liter | Standard Deviation 0.286 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 2,n=38,39,24,24,25 | -0.07 trillion cells per liter | Standard Deviation 0.221 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 32,n=19,15,10,12,13 | 0.04 trillion cells per liter | Standard Deviation 0.362 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 16,n=27,26,21,19,19 | -0.11 trillion cells per liter | Standard Deviation 0.303 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 36,n=15,12,10,12,12 | 0.03 trillion cells per liter | Standard Deviation 0.391 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 12,n=31,28,23,22,22 | -0.11 trillion cells per liter | Standard Deviation 0.237 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 40,n=14,11,8,10,10 | -0.10 trillion cells per liter | Standard Deviation 0.33 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 8,n=34,29,23,22,21 | -0.17 trillion cells per liter | Standard Deviation 0.219 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 52,n=8,5,5,5,4 | -0.05 trillion cells per liter | Standard Deviation 0.332 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 44,n=11,10,6,7,9 | -0.03 trillion cells per liter | Standard Deviation 0.367 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 4,n=36,37,24,22,27 | -0.14 trillion cells per liter | Standard Deviation 0.248 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 24,n=22,21,16,16,16 | -0.01 trillion cells per liter | Standard Deviation 0.289 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 48,n=9,8,4,8,5 | 0.04 trillion cells per liter | Standard Deviation 0.434 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter- Erythrocytes | Week 28,n=18,18,12,14,13 | -0.02 trillion cells per liter | Standard Deviation 0.387 |
Secondary
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 2,n=38,39,24,24,25 | 0.13 Picograms | Standard Deviation 0.571 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 32,n=19,15,10,12,13 | 1.01 Picograms | Standard Deviation 1.498 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 24,n=22,21,16,16,16 | 0.97 Picograms | Standard Deviation 1.491 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 28,n=18,18,12,14,13 | 0.91 Picograms | Standard Deviation 1.659 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 48,n=9,8,4,8,5 | 1.36 Picograms | Standard Deviation 0.633 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 8,n=34,29,23,22,21 | 0.96 Picograms | Standard Deviation 1.041 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 44,n=11,10,6,8,9 | 1.16 Picograms | Standard Deviation 0.727 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 12,n=31,28,23,22,22 | 0.94 Picograms | Standard Deviation 1.341 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 52,n=8,5,5,5,4 | 1.44 Picograms | Standard Deviation 0.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 40,n=14,11,8,10,10 | 1.30 Picograms | Standard Deviation 0.818 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 16,n=27,26,21,19,19 | 1.16 Picograms | Standard Deviation 1.345 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 4,n=36,37,24,22,27 | 0.53 Picograms | Standard Deviation 0.786 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 36,n=15,12,10,12,12 | 1.42 Picograms | Standard Deviation 0.944 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 20,n=25,23,18,18,16 | 1.24 Picograms | Standard Deviation 1.529 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 36,n=15,12,10,12,12 | 1.29 Picograms | Standard Deviation 1.905 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 20,n=25,23,18,18,16 | 1.69 Picograms | Standard Deviation 1.605 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 16,n=27,26,21,19,19 | 1.59 Picograms | Standard Deviation 1.617 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 24,n=22,21,16,16,16 | 1.80 Picograms | Standard Deviation 1.663 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 4,n=36,37,24,22,27 | 0.58 Picograms | Standard Deviation 0.877 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 28,n=18,18,12,14,13 | 1.48 Picograms | Standard Deviation 1.618 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 12,n=31,28,23,22,22 | 1.43 Picograms | Standard Deviation 1.372 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 2,n=38,39,24,24,25 | 0.29 Picograms | Standard Deviation 0.73 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 48,n=9,8,4,8,5 | 2.25 Picograms | Standard Deviation 2.194 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 32,n=19,15,10,12,13 | 1.57 Picograms | Standard Deviation 1.694 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 40,n=14,11,8,10,10 | 1.75 Picograms | Standard Deviation 1.914 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 8,n=34,29,23,22,21 | 1.20 Picograms | Standard Deviation 1.056 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 52,n=8,5,5,5,4 | 2.70 Picograms | Standard Deviation 1.744 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 44,n=11,10,6,8,9 | 1.83 Picograms | Standard Deviation 2.214 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 20,n=25,23,18,18,16 | 1.48 Picograms | Standard Deviation 1.256 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 2,n=38,39,24,24,25 | 0.42 Picograms | Standard Deviation 0.512 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 4,n=36,37,24,22,27 | 0.55 Picograms | Standard Deviation 0.672 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 8,n=34,29,23,22,21 | 1.16 Picograms | Standard Deviation 1.178 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 12,n=31,28,23,22,22 | 1.38 Picograms | Standard Deviation 1.63 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 16,n=27,26,21,19,19 | 1.83 Picograms | Standard Deviation 1.424 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 24,n=22,21,16,16,16 | 1.34 Picograms | Standard Deviation 1.23 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 28,n=18,18,12,14,13 | 1.47 Picograms | Standard Deviation 1.409 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 32,n=19,15,10,12,13 | 1.27 Picograms | Standard Deviation 1.111 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 36,n=15,12,10,12,12 | 1.39 Picograms | Standard Deviation 1.005 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 40,n=14,11,8,10,10 | 1.91 Picograms | Standard Deviation 1.373 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 44,n=11,10,6,8,9 | 1.63 Picograms | Standard Deviation 1.178 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 48,n=9,8,4,8,5 | 1.73 Picograms | Standard Deviation 1.389 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 52,n=8,5,5,5,4 | 2.24 Picograms | Standard Deviation 1.484 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 20,n=25,23,18,18,16 | 0.14 Picograms | Standard Deviation 1.666 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 32,n=19,15,10,12,13 | 0.68 Picograms | Standard Deviation 2.103 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 16,n=27,26,21,19,19 | 0.24 Picograms | Standard Deviation 1.508 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 36,n=15,12,10,12,12 | 0.68 Picograms | Standard Deviation 2.327 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 12,n=31,28,23,22,22 | 0.44 Picograms | Standard Deviation 1.11 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 2,n=38,39,24,24,25 | 0.12 Picograms | Standard Deviation 0.494 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 40,n=14,11,8,10,10 | 0.71 Picograms | Standard Deviation 2.617 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 8,n=34,29,23,22,21 | 0.60 Picograms | Standard Deviation 0.751 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 44,n=11,10,6,8,9 | 0.30 Picograms | Standard Deviation 2.46 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 4,n=36,37,24,22,27 | 0.25 Picograms | Standard Deviation 0.458 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 52,n=8,5,5,5,4 | 1.84 Picograms | Standard Deviation 1.889 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 24,n=22,21,16,16,16 | -0.04 Picograms | Standard Deviation 1.727 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 48,n=9,8,4,8,5 | 0.14 Picograms | Standard Deviation 2.934 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 28,n=18,18,12,14,13 | 0.21 Picograms | Standard Deviation 2 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 24,n=22,21,16,16,16 | -0.08 Picograms | Standard Deviation 2.041 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 52,n=8,5,5,5,4 | 0.80 Picograms | Standard Deviation 1.068 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 32,n=19,15,10,12,13 | -0.14 Picograms | Standard Deviation 1.413 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 16,n=27,26,21,19,19 | 0.22 Picograms | Standard Deviation 1.927 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 28,n=18,18,12,14,13 | -0.20 Picograms | Standard Deviation 1.493 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 2,n=38,39,24,24,25 | 0.22 Picograms | Standard Deviation 0.678 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 44,n=11,10,6,8,9 | 0.77 Picograms | Standard Deviation 1.261 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 36,n=15,12,10,12,12 | 0.15 Picograms | Standard Deviation 0.971 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 12,n=31,28,23,22,22 | 0.47 Picograms | Standard Deviation 1.48 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 4,n=36,37,24,22,27 | 0.36 Picograms | Standard Deviation 0.892 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 20,n=25,23,18,18,16 | 0.39 Picograms | Standard Deviation 1.696 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 48,n=9,8,4,8,5 | 1.32 Picograms | Standard Deviation 1.119 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 40,n=14,11,8,10,10 | 0.44 Picograms | Standard Deviation 1.492 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin | Week 8,n=34,29,23,22,21 | 0.49 Picograms | Standard Deviation 1.022 |
Secondary
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 48,n=9,8,4,8,5 | -0.4 Femtoliter | Standard Deviation 3.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 12,n=31,28,23,22,22 | 0.8 Femtoliter | Standard Deviation 3.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 32,n=19,15,10,12,13 | 0.9 Femtoliter | Standard Deviation 4.42 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 52,n=8,5,5,5,4 | -0.6 Femtoliter | Standard Deviation 3.02 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 40,n=14,11,8,10,10 | 0.6 Femtoliter | Standard Deviation 3.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 8,n=34,29,23,22,21 | 1.2 Femtoliter | Standard Deviation 2.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 16,n=27,26,21,19,19 | 1.0 Femtoliter | Standard Deviation 4.14 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 28,n=18,18,12,14,13 | 0.6 Femtoliter | Standard Deviation 4.02 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 4,n=36,37,24,22,27 | 0.9 Femtoliter | Standard Deviation 1.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 36,n=15,12,10,12,12 | 1.8 Femtoliter | Standard Deviation 3.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 24,n=22,21,16,16,16 | 1.1 Femtoliter | Standard Deviation 4.2 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 20,n=25,23,18,18,16 | 1.2 Femtoliter | Standard Deviation 4.42 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 44,n=11,10,6,8,9 | -0.5 Femtoliter | Standard Deviation 3.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 2,n=38,39,24,24,25 | 0.5 Femtoliter | Standard Deviation 1.35 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 40,n=14,11,8,10,10 | 1.8 Femtoliter | Standard Deviation 5.25 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 24,n=22,21,16,16,16 | 1.1 Femtoliter | Standard Deviation 3.91 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 4,n=36,37,24,22,27 | 1.1 Femtoliter | Standard Deviation 2.15 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 28,n=18,18,12,14,13 | 1.4 Femtoliter | Standard Deviation 4.19 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 2,n=38,39,24,24,25 | 0.5 Femtoliter | Standard Deviation 1.64 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 44,n=11,10,6,8,9 | 2.5 Femtoliter | Standard Deviation 5.08 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 8,n=34,29,23,22,21 | 1.8 Femtoliter | Standard Deviation 3.27 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 52,n=8,5,5,5,4 | 3.2 Femtoliter | Standard Deviation 5.12 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 32,n=19,15,10,12,13 | 2.0 Femtoliter | Standard Deviation 4.44 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 12,n=31,28,23,22,22 | 2.0 Femtoliter | Standard Deviation 4.29 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 36,n=15,12,10,12,12 | 1.6 Femtoliter | Standard Deviation 4.76 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 16,n=27,26,21,19,19 | 2.2 Femtoliter | Standard Deviation 4.36 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 48,n=9,8,4,8,5 | 3.3 Femtoliter | Standard Deviation 4.95 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 20,n=25,23,18,18,16 | 1.8 Femtoliter | Standard Deviation 4.35 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 20,n=25,23,18,18,16 | 2.1 Femtoliter | Standard Deviation 3.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 2,n=38,39,24,24,25 | 0.5 Femtoliter | Standard Deviation 1.38 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 4,n=36,37,24,22,27 | 1.0 Femtoliter | Standard Deviation 1.69 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 8,n=34,29,23,22,21 | 1.9 Femtoliter | Standard Deviation 2.72 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 12,n=31,28,23,22,22 | 2.6 Femtoliter | Standard Deviation 3.14 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 16,n=27,26,21,19,19 | 3.1 Femtoliter | Standard Deviation 3.37 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 24,n=22,21,16,16,16 | 2.6 Femtoliter | Standard Deviation 3.36 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 28,n=18,18,12,14,13 | 2.0 Femtoliter | Standard Deviation 2.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 32,n=19,15,10,12,13 | 1.3 Femtoliter | Standard Deviation 3.13 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 36,n=15,12,10,12,12 | 0.9 Femtoliter | Standard Deviation 2.47 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 48,n=9,8,4,8,5 | 2.3 Femtoliter | Standard Deviation 4.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 40,n=14,11,8,10,10 | 2.0 Femtoliter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 44,n=11,10,6,8,9 | 1.7 Femtoliter | Standard Deviation 3.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 52,n=8,5,5,5,4 | 1.4 Femtoliter | Standard Deviation 4.16 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 36,n=15,12,10,12,12 | -0.5 Femtoliter | Standard Deviation 4.93 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 8,n=34,29,23,22,21 | 1.7 Femtoliter | Standard Deviation 2.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 32,n=19,15,10,12,13 | 0.3 Femtoliter | Standard Deviation 4.89 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 52,n=8,5,5,5,4 | 3.2 Femtoliter | Standard Deviation 5.72 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 44,n=11,10,6,8,9 | -0.7 Femtoliter | Standard Deviation 6.87 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 48,n=9,8,4,8,5 | -1.1 Femtoliter | Standard Deviation 6.92 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 12,n=31,28,23,22,22 | 0.9 Femtoliter | Standard Deviation 3.16 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 16,n=27,26,21,19,19 | 0.4 Femtoliter | Standard Deviation 4.03 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 24,n=22,21,16,16,16 | -1.0 Femtoliter | Standard Deviation 4.44 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 4,n=36,37,24,22,27 | 0.6 Femtoliter | Standard Deviation 1.68 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 28,n=18,18,12,14,13 | -0.4 Femtoliter | Standard Deviation 4.43 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 2,n=38,39,24,24,25 | 0.6 Femtoliter | Standard Deviation 1.38 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 40,n=14,11,8,10,10 | 0.4 Femtoliter | Standard Deviation 4.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 20,n=25,23,18,18,16 | -0.5 Femtoliter | Standard Deviation 4.72 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 40,n=14,11,8,10,10 | -2.1 Femtoliter | Standard Deviation 3 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 32,n=19,15,10,12,13 | -0.5 Femtoliter | Standard Deviation 3.64 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 16,n=27,26,21,19,19 | -0.3 Femtoliter | Standard Deviation 4.98 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 12,n=31,28,23,22,22 | 0.3 Femtoliter | Standard Deviation 4.07 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 2,n=38,39,24,24,25 | 0.4 Femtoliter | Standard Deviation 1.44 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 36,n=15,12,10,12,12 | -0.2 Femtoliter | Standard Deviation 2.55 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 8,n=34,29,23,22,21 | -0.2 Femtoliter | Standard Deviation 2.91 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 52,n=8,5,5,5,4 | 1.0 Femtoliter | Standard Deviation 2.58 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 48,n=9,8,4,8,5 | 2.0 Femtoliter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 4,n=36,37,24,22,27 | 0.6 Femtoliter | Standard Deviation 2.28 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 44,n=11,10,6,8,9 | -0.7 Femtoliter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 24,n=22,21,16,16,16 | -1.6 Femtoliter | Standard Deviation 4.84 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 28,n=18,18,12,14,13 | -0.5 Femtoliter | Standard Deviation 3.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume | Week 20,n=25,23,18,18,16 | 0.1 Femtoliter | Standard Deviation 3.54 |
Secondary
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 36,n=15,12,10,12,12 | 0.0012 Proportion of red blood cells in blood | Standard Deviation 0.02603 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 24,n=22,21,16,16,16 | -0.0017 Proportion of red blood cells in blood | Standard Deviation 0.02882 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 32,n=19,15,10,12,13 | -0.0076 Proportion of red blood cells in blood | Standard Deviation 0.02782 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 28,n=18,18,12,14,13 | -0.0089 Proportion of red blood cells in blood | Standard Deviation 0.02917 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 48,n=9,8,4,8,5 | -0.0136 Proportion of red blood cells in blood | Standard Deviation 0.02709 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 8,n=34,29,23,22,21 | 0.0101 Proportion of red blood cells in blood | Standard Deviation 0.02601 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 44,n=11,10,6,7,9 | -0.0185 Proportion of red blood cells in blood | Standard Deviation 0.03039 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 12,n=31,28,23,22,22 | 0.0087 Proportion of red blood cells in blood | Standard Deviation 0.02386 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 52,n=8,5,5,5,4 | -0.0135 Proportion of red blood cells in blood | Standard Deviation 0.02112 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 2,n=38,39,24,24,25 | 0.0040 Proportion of red blood cells in blood | Standard Deviation 0.01988 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 16,n=27,26,21,19,19 | -0.0037 Proportion of red blood cells in blood | Standard Deviation 0.02187 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 4,n=36,37,24,22,27 | 0.0059 Proportion of red blood cells in blood | Standard Deviation 0.01903 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 40,n=14,11,8,10,10 | -0.0115 Proportion of red blood cells in blood | Standard Deviation 0.03075 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 20,n=25,23,18,18,16 | -0.0063 Proportion of red blood cells in blood | Standard Deviation 0.02436 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 36,n=15,12,10,12,12 | 0.0036 Proportion of red blood cells in blood | Standard Deviation 0.03232 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 32,n=19,15,10,12,13 | 0.0027 Proportion of red blood cells in blood | Standard Deviation 0.02994 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 16,n=27,26,21,19,19 | 0.0049 Proportion of red blood cells in blood | Standard Deviation 0.02833 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 24,n=22,21,16,16,16 | 0.0010 Proportion of red blood cells in blood | Standard Deviation 0.02839 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 2,n=38,39,24,24,25 | 0.0060 Proportion of red blood cells in blood | Standard Deviation 0.02186 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 12,n=31,28,23,22,22 | 0.0148 Proportion of red blood cells in blood | Standard Deviation 0.03272 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 28,n=18,18,12,14,13 | 0.0039 Proportion of red blood cells in blood | Standard Deviation 0.03455 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 4,n=36,37,24,22,27 | 0.0048 Proportion of red blood cells in blood | Standard Deviation 0.02635 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 48,n=9,8,4,8,5 | -0.0025 Proportion of red blood cells in blood | Standard Deviation 0.03217 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 20,n=25,23,18,18,16 | 0.0066 Proportion of red blood cells in blood | Standard Deviation 0.03019 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 40,n=14,11,8,10,10 | -0.0052 Proportion of red blood cells in blood | Standard Deviation 0.03398 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 8,n=34,29,23,22,21 | 0.0054 Proportion of red blood cells in blood | Standard Deviation 0.03213 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 52,n=8,5,5,5,4 | 0.0016 Proportion of red blood cells in blood | Standard Deviation 0.04082 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 44,n=11,10,6,7,9 | 0.0054 Proportion of red blood cells in blood | Standard Deviation 0.03463 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 40,n=14,11,8,10,10 | -0.0009 Proportion of red blood cells in blood | Standard Deviation 0.01086 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 2,n=38,39,24,24,25 | 0.0008 Proportion of red blood cells in blood | Standard Deviation 0.02909 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 4,n=36,37,24,22,27 | 0.0040 Proportion of red blood cells in blood | Standard Deviation 0.01531 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 8,n=34,29,23,22,21 | 0.0019 Proportion of red blood cells in blood | Standard Deviation 0.0211 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 12,n=31,28,23,22,22 | 0.0059 Proportion of red blood cells in blood | Standard Deviation 0.0197 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 16,n=27,26,21,19,19 | 0.0008 Proportion of red blood cells in blood | Standard Deviation 0.01961 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 20,n=25,23,18,18,16 | -0.0015 Proportion of red blood cells in blood | Standard Deviation 0.01398 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 24,n=22,21,16,16,16 | 0.0089 Proportion of red blood cells in blood | Standard Deviation 0.01973 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 28,n=18,18,12,14,13 | -0.0046 Proportion of red blood cells in blood | Standard Deviation 0.01858 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 32,n=19,15,10,12,13 | -0.0060 Proportion of red blood cells in blood | Standard Deviation 0.03161 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 36,n=15,12,10,12,12 | -0.0054 Proportion of red blood cells in blood | Standard Deviation 0.01811 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 44,n=11,10,6,7,9 | -0.0097 Proportion of red blood cells in blood | Standard Deviation 0.02548 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 48,n=9,8,4,8,5 | -0.0053 Proportion of red blood cells in blood | Standard Deviation 0.04366 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 52,n=8,5,5,5,4 | 0.0058 Proportion of red blood cells in blood | Standard Deviation 0.0437 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 36,n=15,12,10,12,12 | -0.0198 Proportion of red blood cells in blood | Standard Deviation 0.0257 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 8,n=34,29,23,22,21 | -0.0054 Proportion of red blood cells in blood | Standard Deviation 0.03286 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 20,n=25,23,18,18,16 | -0.0184 Proportion of red blood cells in blood | Standard Deviation 0.02972 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 44,n=11,10,6,7,9 | -0.0126 Proportion of red blood cells in blood | Standard Deviation 0.03225 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 16,n=27,26,21,19,19 | -0.0135 Proportion of red blood cells in blood | Standard Deviation 0.02976 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 32,n=19,15,10,12,13 | -0.0176 Proportion of red blood cells in blood | Standard Deviation 0.02473 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 4,n=36,37,24,22,27 | -0.0035 Proportion of red blood cells in blood | Standard Deviation 0.02676 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 52,n=8,5,5,5,4 | -0.0006 Proportion of red blood cells in blood | Standard Deviation 0.01558 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 12,n=31,28,23,22,22 | -0.0118 Proportion of red blood cells in blood | Standard Deviation 0.03281 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 40,n=14,11,8,10,10 | -0.0193 Proportion of red blood cells in blood | Standard Deviation 0.02157 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 48,n=9,8,4,8,5 | -0.0216 Proportion of red blood cells in blood | Standard Deviation 0.03428 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 28,n=18,18,12,14,13 | -0.0186 Proportion of red blood cells in blood | Standard Deviation 0.02814 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 2,n=38,39,24,24,25 | -0.0063 Proportion of red blood cells in blood | Standard Deviation 0.02491 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 24,n=22,21,16,16,16 | -0.0133 Proportion of red blood cells in blood | Standard Deviation 0.03478 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 8,n=34,29,23,22,21 | -0.0159 Proportion of red blood cells in blood | Standard Deviation 0.01918 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 2,n=38,39,24,24,25 | -0.0030 Proportion of red blood cells in blood | Standard Deviation 0.01813 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 32,n=19,15,10,12,13 | 0.0025 Proportion of red blood cells in blood | Standard Deviation 0.02741 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 16,n=27,26,21,19,19 | -0.0095 Proportion of red blood cells in blood | Standard Deviation 0.02347 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 36,n=15,12,10,12,12 | 0.0018 Proportion of red blood cells in blood | Standard Deviation 0.0309 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 12,n=31,28,23,22,22 | -0.0095 Proportion of red blood cells in blood | Standard Deviation 0.02108 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 40,n=14,11,8,10,10 | -0.0160 Proportion of red blood cells in blood | Standard Deviation 0.02099 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 20,n=25,23,18,18,16 | -0.0062 Proportion of red blood cells in blood | Standard Deviation 0.02076 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 52,n=8,5,5,5,4 | 0.0025 Proportion of red blood cells in blood | Standard Deviation 0.03288 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 44,n=11,10,6,7,9 | -0.0037 Proportion of red blood cells in blood | Standard Deviation 0.03048 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 4,n=36,37,24,22,27 | -0.0087 Proportion of red blood cells in blood | Standard Deviation 0.02004 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 24,n=22,21,16,16,16 | -0.0077 Proportion of red blood cells in blood | Standard Deviation 0.01599 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 48,n=9,8,4,8,5 | 0.0144 Proportion of red blood cells in blood | Standard Deviation 0.04123 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameter-Hematocrit | Week 28,n=18,18,12,14,13 | -0.0035 Proportion of red blood cells in blood | Standard Deviation 0.02785 |
Secondary
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 2,n=37,36,24,23,25 | 0.015 Giga cells per liter | Standard Deviation 1.1645 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 52,n=8,5,5,5,4 | -1.253 Giga cells per liter | Standard Deviation 1.2857 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 4,n=36,37,24,22,26 | 0.027 Giga cells per liter | Standard Deviation 1.246 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 32,n=19,15,10,12,13 | -57.6 Giga cells per liter | Standard Deviation 66.52 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 48,n=9,8,4,8,5 | -1.258 Giga cells per liter | Standard Deviation 1.2063 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 8,n=34,29,22,22,21 | -0.191 Giga cells per liter | Standard Deviation 1.3361 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 24,n=22,21,16,16,16 | 0.210 Giga cells per liter | Standard Deviation 0.4418 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 44,n=11,10,6,7,9 | -0.915 Giga cells per liter | Standard Deviation 1.2235 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 12,n=31,28,23,22,22 | -0.215 Giga cells per liter | Standard Deviation 1.3052 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 40,n=14,11,8,10,10 | -0.929 Giga cells per liter | Standard Deviation 1.5351 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 16,n=27,26,20,19,19 | -0.450 Giga cells per liter | Standard Deviation 1.345 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 36,n=15,12,10,12,12 | -0.625 Giga cells per liter | Standard Deviation 1.5738 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 20,n=25,22,18,17,16 | -0.616 Giga cells per liter | Standard Deviation 1.2793 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 32,n=19,15,10,12,13 | -0.602 Giga cells per liter | Standard Deviation 1.3438 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 24,n=22,21,16,16,16 | -0.399 Giga cells per liter | Standard Deviation 1.4276 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 28,n=18,18,11,14,13 | -70.2 Giga cells per liter | Standard Deviation 45.09 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 28,n=18,18,11,14,13 | -0.614 Giga cells per liter | Standard Deviation 1.545 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 28,n=18,18,11,14,13 | 0.163 Giga cells per liter | Standard Deviation 0.2562 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 24,n=22,21,16,16,16 | -58.0 Giga cells per liter | Standard Deviation 39.58 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 32,n=19,15,10,12,13 | 0.244 Giga cells per liter | Standard Deviation 0.3707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 48,n=9,8,4,8,5 | -68.3 Giga cells per liter | Standard Deviation 41.94 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 20,n=25,22,18,17,16 | -52.2 Giga cells per liter | Standard Deviation 54.64 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 36,n=15,12,10,12,12 | 0.282 Giga cells per liter | Standard Deviation 0.3117 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 8,n=34,29,22,22,21 | 0.056 Giga cells per liter | Standard Deviation 0.0959 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 16,n=27,26,20,19,19 | -53.8 Giga cells per liter | Standard Deviation 33.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 40,n=14,11,8,10,10 | 0.191 Giga cells per liter | Standard Deviation 0.2175 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 12,n=31,28,23,22,22 | -51.2 Giga cells per liter | Standard Deviation 33.25 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 44,n=11,10,6,7,9 | 0.144 Giga cells per liter | Standard Deviation 0.1952 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 8,n=34,29,22,22,21 | -37.3 Giga cells per liter | Standard Deviation 31.22 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 48,n=9,8,4,8,5 | 0.091 Giga cells per liter | Standard Deviation 0.0664 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 4,n=36,37,24,22,26 | -45.9 Giga cells per liter | Standard Deviation 41.7 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 52,n=8,5,5,5,4 | 0.151 Giga cells per liter | Standard Deviation 0.1865 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 44,n=11,10,6,7,9 | -69.5 Giga cells per liter | Standard Deviation 36.62 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 2,n=37,38,24,23,25 | -39.0 Giga cells per liter | Standard Deviation 39.46 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 2,n=37,38,24,24,25 | -3.12 Giga cells per liter | Standard Deviation 2.268 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 12,n=31,28,23,22,22 | 0.077 Giga cells per liter | Standard Deviation 0.1128 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 52,n=8,5,5,5,4 | -5.520 Giga cells per liter | Standard Deviation 2.7316 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 4,n=36,37,24,22,26 | -3.66 Giga cells per liter | Standard Deviation 2.621 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 48,n=9,8,4,8,5 | -5.628 Giga cells per liter | Standard Deviation 2.3471 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 8,n=34,29,23,22,21 | -4.04 Giga cells per liter | Standard Deviation 2.481 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 52,n=8,5,5,5,4 | -81.9 Giga cells per liter | Standard Deviation 38.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 44,n=11,10,6,7,9 | -5.432 Giga cells per liter | Standard Deviation 2.5555 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 12,n=31,28,23,22,22 | -4.68 Giga cells per liter | Standard Deviation 2.666 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 40,n=14,11,8,10,10 | -5.416 Giga cells per liter | Standard Deviation 2.4371 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 16,n=27,26,20,19,19 | -5.21 Giga cells per liter | Standard Deviation 2.244 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 40,n=14,11,8,10,10 | -77.4 Giga cells per liter | Standard Deviation 41.72 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 36,n=15,12,10,12,12 | -5.444 Giga cells per liter | Standard Deviation 2.1894 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 20,n=25,23,18,18,16 | -5.24 Giga cells per liter | Standard Deviation 1.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 16,n=27,26,20,19,19 | 0.097 Giga cells per liter | Standard Deviation 0.1307 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 32,n=19,15,10,12,13 | -5.357 Giga cells per liter | Standard Deviation 2.5525 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 24,n=22,21,16,16,16 | -5.14 Giga cells per liter | Standard Deviation 3.559 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 28,n=18,18,11,14,13 | -5.076 Giga cells per liter | Standard Deviation 2.3415 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 28,n=18,18,12,14,13 | -5.46 Giga cells per liter | Standard Deviation 2.619 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 4,n=36,37,24,22,26 | 0.043 Giga cells per liter | Standard Deviation 0.0934 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 24,n=22,21,16,16,16 | -4.985 Giga cells per liter | Standard Deviation 3.5051 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 32,n=19,15,10,12,13 | -5.71 Giga cells per liter | Standard Deviation 2.419 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 20,n=25,22,18,17,16 | -4.867 Giga cells per liter | Standard Deviation 2.311 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 36,n=15,12,10,12,12 | -5.76 Giga cells per liter | Standard Deviation 2.106 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 36,n=15,12,10,12,12 | -74.1 Giga cells per liter | Standard Deviation 32.84 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 16,n=27,26,20,19,19 | -4.933 Giga cells per liter | Standard Deviation 2.443 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 40,n=14,11,8,10,10 | -6.14 Giga cells per liter | Standard Deviation 1.987 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 20,n=25,22,18,17,16 | 0.166 Giga cells per liter | Standard Deviation 0.2073 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 12,n=31,28,23,22,22 | -4.590 Giga cells per liter | Standard Deviation 2.6603 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 44,n=11,10,6,7,9 | -6.25 Giga cells per liter | Standard Deviation 2.3 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 8,n=34,29,22,22,21 | -3.949 Giga cells per liter | Standard Deviation 2.5477 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 48,n=9,8,4,8,5 | -6.88 Giga cells per liter | Standard Deviation 2.436 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 2,n=37,36,24,23,25 | 0.019 Giga cells per liter | Standard Deviation 0.0543 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 4,n=36,37,24,22,26 | -3.791 Giga cells per liter | Standard Deviation 2.5242 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 52,n=8,5,5,5,4 | -6.66 Giga cells per liter | Standard Deviation 2.654 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 2,n=37,36,24,23,25 | -3.208 Giga cells per liter | Standard Deviation 2.5761 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 40,n=14,11,8,10,10 | -7.10 Giga cells per liter | Standard Deviation 2.534 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 2,n=37,36,24,23,25 | 0.002 Giga cells per liter | Standard Deviation 1.262 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 32,n=19,15,10,12,13 | -65.5 Giga cells per liter | Standard Deviation 51.2 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 52,n=8,5,5,5,4 | -0.754 Giga cells per liter | Standard Deviation 1.0291 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 2,n=37,38,24,24,25 | -3.63 Giga cells per liter | Standard Deviation 1.971 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 48,n=9,8,4,8,5 | -7.35 Giga cells per liter | Standard Deviation 2.853 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 4,n=36,37,24,22,26 | -0.255 Giga cells per liter | Standard Deviation 1.2225 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 52,n=8,5,5,5,4 | -6.774 Giga cells per liter | Standard Deviation 2.6817 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 48,n=9,8,4,8,5 | -0.923 Giga cells per liter | Standard Deviation 1.4811 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 28,n=18,18,12,14,13 | -6.04 Giga cells per liter | Standard Deviation 3.274 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 12,n=31,28,23,22,22 | -5.340 Giga cells per liter | Standard Deviation 2.6437 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 8,n=34,29,22,22,21 | -0.411 Giga cells per liter | Standard Deviation 1.2086 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 4,n=36,37,24,22,26 | -4.76 Giga cells per liter | Standard Deviation 2.411 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 44,n=11,10,6,7,9 | -1.047 Giga cells per liter | Standard Deviation 1.3375 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 12,n=31,28,23,22,22 | 0.155 Giga cells per liter | Standard Deviation 0.1971 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 48,n=9,8,4,8,5 | -6.396 Giga cells per liter | Standard Deviation 3.4832 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 12,n=31,28,23,22,22 | -0.437 Giga cells per liter | Standard Deviation 1.2479 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 24,n=22,21,16,16,16 | 0.109 Giga cells per liter | Standard Deviation 0.159 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 40,n=14,11,8,10,10 | -0.845 Giga cells per liter | Standard Deviation 1.3603 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 24,n=22,21,16,16,16 | -6.257 Giga cells per liter | Standard Deviation 2.7551 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 52,n=8,5,5,5,4 | -7.36 Giga cells per liter | Standard Deviation 2.92 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 16,n=27,26,20,19,19 | -0.704 Giga cells per liter | Standard Deviation 1.2994 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 2,n=37,36,24,23,25 | 0.001 Giga cells per liter | Standard Deviation 0.069 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 36,n=15,12,10,12,12 | -0.672 Giga cells per liter | Standard Deviation 1.2263 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 8,n=34,29,23,22,21 | -5.65 Giga cells per liter | Standard Deviation 3.672 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 4,n=36,37,24,22,26 | -4.476 Giga cells per liter | Standard Deviation 2.3632 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 20,n=25,22,18,17,16 | -0.313 Giga cells per liter | Standard Deviation 1.3011 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 28,n=18,18,11,14,13 | -61.3 Giga cells per liter | Standard Deviation 54.34 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 32,n=19,15,10,12,13 | -0.407 Giga cells per liter | Standard Deviation 1.4002 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 44,n=11,10,6,7,9 | -5.799 Giga cells per liter | Standard Deviation 3.1785 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 32,n=19,15,10,12,13 | -5.61 Giga cells per liter | Standard Deviation 3.25 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 24,n=22,21,16,16,16 | -0.179 Giga cells per liter | Standard Deviation 1.8386 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 36,n=15,12,10,12,12 | -70.6 Giga cells per liter | Standard Deviation 58.49 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 28,n=18,18,11,14,13 | -0.273 Giga cells per liter | Standard Deviation 1.3296 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 12,n=31,28,23,22,22 | -5.67 Giga cells per liter | Standard Deviation 2.551 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 40,n=14,11,8,10,10 | -66.9 Giga cells per liter | Standard Deviation 62.21 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 28,n=18,18,11,14,13 | 0.068 Giga cells per liter | Standard Deviation 0.134 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 48,n=9,8,4,8,5 | -71.4 Giga cells per liter | Standard Deviation 57.71 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 24,n=22,21,16,16,16 | -72.4 Giga cells per liter | Standard Deviation 64.56 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 40,n=14,11,8,10,10 | -6.179 Giga cells per liter | Standard Deviation 2.8859 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 20,n=25,22,18,17,16 | -4.997 Giga cells per liter | Standard Deviation 3.0763 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 32,n=19,15,10,12,13 | 0.069 Giga cells per liter | Standard Deviation 0.158 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 44,n=11,10,6,7,9 | -6.95 Giga cells per liter | Standard Deviation 2.441 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 20,n=25,22,18,17,16 | -69.5 Giga cells per liter | Standard Deviation 58.27 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 16,n=27,26,20,19,19 | -5.61 Giga cells per liter | Standard Deviation 3.502 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 20,n=25,22,18,17,16 | 0.114 Giga cells per liter | Standard Deviation 0.2085 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 36,n=15,12,10,12,12 | 0.076 Giga cells per liter | Standard Deviation 0.1753 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 36,n=15,12,10,12,12 | -6.079 Giga cells per liter | Standard Deviation 3.0406 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 16,n=27,26,20,19,19 | -69.9 Giga cells per liter | Standard Deviation 53.79 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 36,n=15,12,10,12,12 | -6.82 Giga cells per liter | Standard Deviation 2.814 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 8,n=34,29,22,22,21 | -5.271 Giga cells per liter | Standard Deviation 3.2214 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 40,n=14,11,8,10,10 | 0.075 Giga cells per liter | Standard Deviation 0.1924 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 8,n=34,29,22,22,21 | 0.102 Giga cells per liter | Standard Deviation 0.1634 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 12,n=31,28,23,22,22 | -74.0 Giga cells per liter | Standard Deviation 52.17 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 20,n=25,23,18,18,16 | -5.20 Giga cells per liter | Standard Deviation 3.104 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 16,n=27,26,20,19,19 | -4.929 Giga cells per liter | Standard Deviation 3.7907 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 44,n=11,10,6,7,9 | 0.045 Giga cells per liter | Standard Deviation 0.1329 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 52,n=8,5,5,5,4 | -51.6 Giga cells per liter | Standard Deviation 43.9 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 8,n=34,29,22,22,21 | -72.2 Giga cells per liter | Standard Deviation 75.77 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 32,n=19,15,10,12,13 | -5.153 Giga cells per liter | Standard Deviation 3.1939 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 4,n=36,37,24,22,26 | 0.035 Giga cells per liter | Standard Deviation 0.1238 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 48,n=9,8,4,8,5 | 0.059 Giga cells per liter | Standard Deviation 0.1561 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 44,n=11,10,6,7,9 | -76.7 Giga cells per liter | Standard Deviation 64.91 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 4,n=36,37,24,22,26 | -64.3 Giga cells per liter | Standard Deviation 56.21 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 2,n=37,36,24,23,25 | -3.454 Giga cells per liter | Standard Deviation 2.2265 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 24,n=22,21,16,16,16 | -6.39 Giga cells per liter | Standard Deviation 2.952 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 52,n=8,5,5,5,4 | 0.192 Giga cells per liter | Standard Deviation 0.1839 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 16,n=27,26,20,19,19 | 0.162 Giga cells per liter | Standard Deviation 0.217 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 2,n=37,38,24,23,25 | -49.2 Giga cells per liter | Standard Deviation 52.77 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 28,n=18,18,11,14,13 | -5.729 Giga cells per liter | Standard Deviation 3.1699 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 48,n=9,8,4,8,5 | -6.48 Giga cells per liter | Standard Deviation 2.887 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 2,n=37,36,24,23,25 | 0.010 Giga cells per liter | Standard Deviation 0.0433 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 4,n=36,37,24,22,26 | 0.012 Giga cells per liter | Standard Deviation 0.0719 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 8,n=34,29,22,22,21 | 0.054 Giga cells per liter | Standard Deviation 0.1036 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 12,n=31,28,23,22,22 | 0.090 Giga cells per liter | Standard Deviation 0.086 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 16,n=27,26,20,19,19 | 0.117 Giga cells per liter | Standard Deviation 0.1772 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 20,n=25,22,18,17,16 | 0.136 Giga cells per liter | Standard Deviation 0.1518 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 24,n=22,21,16,16,16 | 0.109 Giga cells per liter | Standard Deviation 0.1094 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 28,n=18,18,11,14,13 | 0.120 Giga cells per liter | Standard Deviation 0.134 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 32,n=19,15,10,12,13 | 0.092 Giga cells per liter | Standard Deviation 0.1253 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 36,n=15,12,10,12,12 | 0.153 Giga cells per liter | Standard Deviation 0.1166 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 40,n=14,11,8,10,10 | 0.104 Giga cells per liter | Standard Deviation 0.1161 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 44,n=11,10,6,7,9 | 0.165 Giga cells per liter | Standard Deviation 0.1564 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 48,n=9,8,4,8,5 | 0.233 Giga cells per liter | Standard Deviation 0.2387 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 52,n=8,5,5,5,4 | 0.172 Giga cells per liter | Standard Deviation 0.1207 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 2,n=37,38,24,24,25 | -3.32 Giga cells per liter | Standard Deviation 2.816 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 4,n=36,37,24,22,26 | -4.07 Giga cells per liter | Standard Deviation 2.157 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 8,n=34,29,23,22,21 | -4.42 Giga cells per liter | Standard Deviation 2.469 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 12,n=31,28,23,22,22 | -5.23 Giga cells per liter | Standard Deviation 2.581 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 16,n=27,26,20,19,19 | -5.36 Giga cells per liter | Standard Deviation 2.309 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 20,n=25,23,18,18,16 | -5.40 Giga cells per liter | Standard Deviation 2.414 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 24,n=22,21,16,16,16 | -5.01 Giga cells per liter | Standard Deviation 1.884 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 28,n=18,18,12,14,13 | -4.58 Giga cells per liter | Standard Deviation 2.143 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 32,n=19,15,10,12,13 | -5.27 Giga cells per liter | Standard Deviation 1.696 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 36,n=15,12,10,12,12 | -5.58 Giga cells per liter | Standard Deviation 1.757 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 40,n=14,11,8,10,10 | -6.46 Giga cells per liter | Standard Deviation 2.13 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 44,n=11,10,6,7,9 | -6.17 Giga cells per liter | Standard Deviation 1.726 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 52,n=8,5,5,5,4 | -6.38 Giga cells per liter | Standard Deviation 2.262 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 2,n=37,36,24,23,25 | -0.041 Giga cells per liter | Standard Deviation 1.3241 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 4,n=36,37,24,22,26 | 0.057 Giga cells per liter | Standard Deviation 1.2338 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 8,n=34,29,22,22,21 | -0.067 Giga cells per liter | Standard Deviation 1.2814 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 12,n=31,28,23,22,22 | -0.081 Giga cells per liter | Standard Deviation 1.2018 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 16,n=27,26,20,19,19 | -0.153 Giga cells per liter | Standard Deviation 0.7804 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 20,n=25,22,18,17,16 | -0.439 Giga cells per liter | Standard Deviation 1.4363 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 24,n=22,21,16,16,16 | -0.073 Giga cells per liter | Standard Deviation 0.789 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 28,n=18,18,11,14,13 | -0.192 Giga cells per liter | Standard Deviation 0.7271 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 32,n=19,15,10,12,13 | -0.476 Giga cells per liter | Standard Deviation 0.7997 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 36,n=15,12,10,12,12 | -0.430 Giga cells per liter | Standard Deviation 0.769 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 40,n=14,11,8,10,10 | -0.570 Giga cells per liter | Standard Deviation 0.8261 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 44,n=11,10,6,7,9 | -0.198 Giga cells per liter | Standard Deviation 0.9783 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 48,n=9,8,4,8,5 | 0.118 Giga cells per liter | Standard Deviation 1.0588 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 52,n=8,5,5,5,4 | -0.286 Giga cells per liter | Standard Deviation 1.0455 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 2,n=37,36,24,23,25 | -3.367 Giga cells per liter | Standard Deviation 2.5781 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 4,n=36,37,24,22,26 | -4.106 Giga cells per liter | Standard Deviation 2.4354 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 8,n=34,29,22,22,21 | -4.354 Giga cells per liter | Standard Deviation 2.4128 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 12,n=31,28,23,22,22 | -5.250 Giga cells per liter | Standard Deviation 2.1872 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 16,n=27,26,20,19,19 | -5.358 Giga cells per liter | Standard Deviation 2.2367 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 20,n=25,22,18,17,16 | -5.168 Giga cells per liter | Standard Deviation 2.4898 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 24,n=22,21,16,16,16 | -5.030 Giga cells per liter | Standard Deviation 1.9579 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 28,n=18,18,11,14,13 | -4.469 Giga cells per liter | Standard Deviation 2.1333 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 32,n=19,15,10,12,13 | -4.840 Giga cells per liter | Standard Deviation 1.9387 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 36,n=15,12,10,12,12 | -5.265 Giga cells per liter | Standard Deviation 1.8375 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 40,n=14,11,8,10,10 | -5.916 Giga cells per liter | Standard Deviation 1.7172 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 44,n=11,10,6,7,9 | -6.185 Giga cells per liter | Standard Deviation 1.3944 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 48,n=9,8,4,8,5 | -6.790 Giga cells per liter | Standard Deviation 1.606 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 52,n=8,5,5,5,4 | -6.256 Giga cells per liter | Standard Deviation 1.8929 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 2,n=37,38,24,23,25 | -41.1 Giga cells per liter | Standard Deviation 40.29 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 4,n=36,37,24,22,26 | -49.0 Giga cells per liter | Standard Deviation 35.74 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 8,n=34,29,22,22,21 | -53.3 Giga cells per liter | Standard Deviation 37.1 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 12,n=31,28,23,22,22 | -55.4 Giga cells per liter | Standard Deviation 38.89 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 16,n=27,26,20,19,19 | -54.8 Giga cells per liter | Standard Deviation 39.71 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 20,n=25,22,18,17,16 | -53.5 Giga cells per liter | Standard Deviation 38 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 24,n=22,21,16,16,16 | -57.5 Giga cells per liter | Standard Deviation 44.46 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 28,n=18,18,11,14,13 | -50.6 Giga cells per liter | Standard Deviation 27.71 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 32,n=19,15,10,12,13 | -50.8 Giga cells per liter | Standard Deviation 33.7 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 36,n=15,12,10,12,12 | -48.6 Giga cells per liter | Standard Deviation 23.64 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 40,n=14,11,8,10,10 | -42.0 Giga cells per liter | Standard Deviation 21.33 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 44,n=11,10,6,7,9 | -58.2 Giga cells per liter | Standard Deviation 19.28 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 48,n=9,8,4,8,5 | -80.8 Giga cells per liter | Standard Deviation 22.98 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 52,n=8,5,5,5,4 | -58.6 Giga cells per liter | Standard Deviation 40.79 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 24,n=22,21,16,16,16 | -2.89 Giga cells per liter | Standard Deviation 3.892 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 52,n=8,5,5,5,4 | 0.108 Giga cells per liter | Standard Deviation 0.1139 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 8,n=34,29,22,22,21 | 0.048 Giga cells per liter | Standard Deviation 0.1498 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 2,n=37,38,24,23,25 | -1.9 Giga cells per liter | Standard Deviation 37.57 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 2,n=37,36,24,23,25 | -0.748 Giga cells per liter | Standard Deviation 2.2688 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 28,n=18,18,11,14,13 | -2.764 Giga cells per liter | Standard Deviation 3.5787 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 48,n=9,8,4,8,5 | 0.028 Giga cells per liter | Standard Deviation 0.0489 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 44,n=11,10,6,7,9 | -2.83 Giga cells per liter | Standard Deviation 3.875 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 4,n=36,37,24,22,26 | 2.1 Giga cells per liter | Standard Deviation 41.23 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 36,n=15,12,10,12,12 | -3.36 Giga cells per liter | Standard Deviation 3.612 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 20,n=25,23,18,18,16 | -3.24 Giga cells per liter | Standard Deviation 3.592 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 44,n=11,10,6,7,9 | 0.024 Giga cells per liter | Standard Deviation 0.0541 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 44,n=11,10,6,7,9 | 11.1 Giga cells per liter | Standard Deviation 48.18 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 8,n=34,29,22,22,21 | 14.2 Giga cells per liter | Standard Deviation 45.62 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 16,n=27,26,20,19,19 | 0.067 Giga cells per liter | Standard Deviation 0.1148 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 32,n=19,15,10,12,13 | -3.006 Giga cells per liter | Standard Deviation 3.7915 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 40,n=14,11,8,10,10 | 0.065 Giga cells per liter | Standard Deviation 0.0737 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 16,n=27,26,20,19,19 | -2.766 Giga cells per liter | Standard Deviation 3.3212 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 12,n=31,28,23,22,22 | 17.8 Giga cells per liter | Standard Deviation 50.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 48,n=9,8,4,8,5 | -2.69 Giga cells per liter | Standard Deviation 2.979 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 16,n=27,26,20,19,19 | -2.98 Giga cells per liter | Standard Deviation 3.018 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 36,n=15,12,10,12,12 | 0.049 Giga cells per liter | Standard Deviation 0.072 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 12,n=31,28,23,22,22 | 0.090 Giga cells per liter | Standard Deviation 0.1684 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 16,n=27,26,20,19,19 | 12.4 Giga cells per liter | Standard Deviation 52.98 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 36,n=15,12,10,12,12 | -3.023 Giga cells per liter | Standard Deviation 3.9443 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 8,n=34,29,22,22,21 | -1.869 Giga cells per liter | Standard Deviation 3.2525 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 32,n=19,15,10,12,13 | 0.038 Giga cells per liter | Standard Deviation 0.0597 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 4,n=36,37,24,22,26 | 0.023 Giga cells per liter | Standard Deviation 0.0617 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 20,n=25,22,18,17,16 | 14.8 Giga cells per liter | Standard Deviation 44.55 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 32,n=19,15,10,12,13 | -3.43 Giga cells per liter | Standard Deviation 3.342 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 12,n=31,28,23,22,22 | -2.66 Giga cells per liter | Standard Deviation 2.883 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 28,n=18,18,11,14,13 | 0.046 Giga cells per liter | Standard Deviation 0.0714 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 52,n=8,5,5,5,4 | -18.6 Giga cells per liter | Standard Deviation 55.44 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 24,n=22,21,16,16,16 | 6.3 Giga cells per liter | Standard Deviation 46.94 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 2,n=37,36,24,23,25 | 0.015 Giga cells per liter | Standard Deviation 0.0557 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 40,n=14,11,8,10,10 | -2.705 Giga cells per liter | Standard Deviation 3.4469 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 24,n=22,21,16,16,16 | -0.401 Giga cells per liter | Standard Deviation 1.203 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 32,n=19,15,10,12,13 | -1.5 Giga cells per liter | Standard Deviation 45.26 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 28,n=18,18,11,14,13 | -0.258 Giga cells per liter | Standard Deviation 1.0211 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 20,n=25,22,18,17,16 | -2.856 Giga cells per liter | Standard Deviation 4.0311 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 8,n=34,29,23,22,21 | -1.79 Giga cells per liter | Standard Deviation 2.682 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 20,n=25,22,18,17,16 | -0.385 Giga cells per liter | Standard Deviation 0.8819 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 24,n=22,21,16,16,16 | 0.089 Giga cells per liter | Standard Deviation 0.2392 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 32,n=19,15,10,12,13 | -0.402 Giga cells per liter | Standard Deviation 1.2625 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 40,n=14,11,8,10,10 | 5.6 Giga cells per liter | Standard Deviation 45.38 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 44,n=11,10,6,7,9 | -1.807 Giga cells per liter | Standard Deviation 4.5472 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 16,n=27,26,20,19,19 | -0.327 Giga cells per liter | Standard Deviation 1.4269 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 48,n=9,8,4,8,5 | 14.4 Giga cells per liter | Standard Deviation 53.59 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 36,n=15,12,10,12,12 | -0.417 Giga cells per liter | Standard Deviation 1.0538 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 4,n=36,37,24,22,26 | -1.673 Giga cells per liter | Standard Deviation 1.9745 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 40,n=14,11,8,10,10 | -3.18 Giga cells per liter | Standard Deviation 3.662 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 12,n=31,28,23,22,22 | -0.128 Giga cells per liter | Standard Deviation 1.0505 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 28,n=18,18,11,14,13 | 15.4 Giga cells per liter | Standard Deviation 31.84 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 40,n=14,11,8,10,10 | -0.519 Giga cells per liter | Standard Deviation 1.1491 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 4,n=36,37,24,22,26 | -1.64 Giga cells per liter | Standard Deviation 2.247 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 28,n=18,18,12,14,13 | -3.01 Giga cells per liter | Standard Deviation 3.368 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 8,n=34,29,22,22,21 | -0.049 Giga cells per liter | Standard Deviation 1.0832 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 48,n=9,8,4,8,5 | -2.160 Giga cells per liter | Standard Deviation 3.3843 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 44,n=11,10,6,7,9 | -1.029 Giga cells per liter | Standard Deviation 1.0293 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 36,n=15,12,10,12,12 | 13.4 Giga cells per liter | Standard Deviation 32.69 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 24,n=22,21,16,16,16 | -2.570 Giga cells per liter | Standard Deviation 4.2089 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 4,n=36,37,24,22,26 | -0.002 Giga cells per liter | Standard Deviation 0.734 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 2,n=37,38,24,24,25 | -0.76 Giga cells per liter | Standard Deviation 2.145 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 48,n=9,8,4,8,5 | -0.576 Giga cells per liter | Standard Deviation 1.1994 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 52,n=8,5,5,5,4 | -3.84 Giga cells per liter | Standard Deviation 3.467 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 52,n=8,5,5,5,4 | -4.214 Giga cells per liter | Standard Deviation 3.6948 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 2,n=37,36,24,23,25 | -0.159 Giga cells per liter | Standard Deviation 0.9064 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 20,n=25,22,18,17,16 | 0.094 Giga cells per liter | Standard Deviation 0.1743 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 52,n=8,5,5,5,4 | 0.194 Giga cells per liter | Standard Deviation 0.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 12,n=31,28,23,22,22 | -2.678 Giga cells per liter | Standard Deviation 3.1106 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 52,n=8,5,5,5,4 | -0.128 Giga cells per liter | Standard Deviation 1.2618 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 48,n=9,8,4,8,5 | 0.4 Giga cells per liter | Standard Deviation 61.59 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 2,n=37,36,24,23,25 | 0.387 Giga cells per liter | Standard Deviation 2.6156 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 48,n=9,8,4,8,5 | -3.00 Giga cells per liter | Standard Deviation 3.045 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 4,n=36,37,24,22,26 | 0.089 Giga cells per liter | Standard Deviation 3.1611 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 44,n=11,10,6,7,9 | -3.08 Giga cells per liter | Standard Deviation 3.056 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 32,n=19,15,10,12,13 | 10.7 Giga cells per liter | Standard Deviation 53.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 8,n=34,29,22,22,21 | 0.192 Giga cells per liter | Standard Deviation 2.218 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 40,n=14,11,8,10,10 | -2.23 Giga cells per liter | Standard Deviation 3.142 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 16,n=27,26,20,19,19 | 0.067 Giga cells per liter | Standard Deviation 0.1746 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 12,n=31,28,23,22,22 | -1.019 Giga cells per liter | Standard Deviation 2.1306 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 36,n=15,12,10,12,12 | -2.95 Giga cells per liter | Standard Deviation 3.635 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 16,n=27,26,20,19,19 | -0.263 Giga cells per liter | Standard Deviation 3.361 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 32,n=19,15,10,12,13 | -2.33 Giga cells per liter | Standard Deviation 3.011 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 2,n=37,36,24,23,25 | 0.062 Giga cells per liter | Standard Deviation 0.2084 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 20,n=25,22,18,17,16 | -1.355 Giga cells per liter | Standard Deviation 3.3883 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 28,n=18,18,12,14,13 | -1.97 Giga cells per liter | Standard Deviation 3.461 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 24,n=22,21,16,16,16 | -1.342 Giga cells per liter | Standard Deviation 3.1038 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 24,n=22,21,16,16,16 | -1.52 Giga cells per liter | Standard Deviation 2.738 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 36,n=15,12,10,12,12 | 20.0 Giga cells per liter | Standard Deviation 85.28 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 28,n=18,18,11,14,13 | -1.503 Giga cells per liter | Standard Deviation 4.3502 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 20,n=25,23,18,18,16 | -1.71 Giga cells per liter | Standard Deviation 2.84 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 12,n=31,28,23,22,22 | 0.030 Giga cells per liter | Standard Deviation 0.0548 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 32,n=19,15,10,12,13 | -2.018 Giga cells per liter | Standard Deviation 3.5674 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 16,n=27,26,20,19,19 | -0.79 Giga cells per liter | Standard Deviation 3.018 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 36,n=15,12,10,12,12 | -3.018 Giga cells per liter | Standard Deviation 4.1223 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 12,n=31,28,23,22,22 | -1.28 Giga cells per liter | Standard Deviation 1.81 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 40,n=14,11,8,10,10 | -1.663 Giga cells per liter | Standard Deviation 3.409 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 8,n=34,29,23,22,21 | -0.26 Giga cells per liter | Standard Deviation 1.88 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 44,n=11,10,6,7,9 | -2.883 Giga cells per liter | Standard Deviation 3.869 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 4,n=36,37,24,22,26 | -0.16 Giga cells per liter | Standard Deviation 2.33 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 40,n=14,11,8,10,10 | 5.3 Giga cells per liter | Standard Deviation 54.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 48,n=9,8,4,8,5 | -2.650 Giga cells per liter | Standard Deviation 4.0017 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 2,n=37,38,24,24,25 | 0.34 Giga cells per liter | Standard Deviation 2.238 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 8,n=34,29,22,22,21 | 0.010 Giga cells per liter | Standard Deviation 0.0591 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Neutrophils,Week 52,n=8,5,5,5,4 | -2.990 Giga cells per liter | Standard Deviation 4.8629 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 52,n=8,5,5,5,4 | 0.013 Giga cells per liter | Standard Deviation 0.0802 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 2,n=37,38,24,23,25 | -4.3 Giga cells per liter | Standard Deviation 49.32 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 48,n=9,8,4,8,5 | 0.030 Giga cells per liter | Standard Deviation 0.0604 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 52,n=8,5,5,5,4 | -17.5 Giga cells per liter | Standard Deviation 38.04 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 4,n=36,37,24,22,26 | -5.7 Giga cells per liter | Standard Deviation 43.51 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 44,n=11,10,6,7,9 | 0.066 Giga cells per liter | Standard Deviation 0.06 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 8,n=34,29,22,22,21 | 15.7 Giga cells per liter | Standard Deviation 57.21 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 40,n=14,11,8,10,10 | 0.071 Giga cells per liter | Standard Deviation 0.114 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 44,n=11,10,6,7,9 | -3.3 Giga cells per liter | Standard Deviation 56.78 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 12,n=31,28,23,22,22 | 4.3 Giga cells per liter | Standard Deviation 55.14 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 36,n=15,12,10,12,12 | 0.059 Giga cells per liter | Standard Deviation 0.0585 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 4,n=36,37,24,22,26 | 0.030 Giga cells per liter | Standard Deviation 0.1164 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 16,n=27,26,20,19,19 | 13.8 Giga cells per liter | Standard Deviation 60.11 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 32,n=19,15,10,12,13 | 0.056 Giga cells per liter | Standard Deviation 0.0733 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 20,n=25,22,18,17,16 | -0.1 Giga cells per liter | Standard Deviation 56.21 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 28,n=18,18,11,14,13 | 0.051 Giga cells per liter | Standard Deviation 0.0538 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 24,n=22,21,16,16,16 | 20.1 Giga cells per liter | Standard Deviation 45.3 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 24,n=22,21,16,16,16 | -0.386 Giga cells per liter | Standard Deviation 0.7504 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 24,n=22,21,16,16,16 | 0.051 Giga cells per liter | Standard Deviation 0.0676 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 28,n=18,18,11,14,13 | -0.565 Giga cells per liter | Standard Deviation 1.0397 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 20,n=25,22,18,17,16 | -0.533 Giga cells per liter | Standard Deviation 0.7432 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 32,n=19,15,10,12,13 | -0.492 Giga cells per liter | Standard Deviation 0.7877 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 16,n=27,26,20,19,19 | -0.635 Giga cells per liter | Standard Deviation 0.8037 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 36,n=15,12,10,12,12 | -0.078 Giga cells per liter | Standard Deviation 0.7182 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 12,n=31,28,23,22,22 | -0.344 Giga cells per liter | Standard Deviation 0.7846 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 40,n=14,11,8,10,10 | -0.681 Giga cells per liter | Standard Deviation 0.7363 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 8,n=34,29,22,22,21 | -0.516 Giga cells per liter | Standard Deviation 0.8562 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Platelets,Week 28,n=18,18,11,14,13 | 13.1 Giga cells per liter | Standard Deviation 47.56 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 44,n=11,10,6,7,9 | -0.343 Giga cells per liter | Standard Deviation 0.8113 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 4,n=36,37,24,22,26 | -0.382 Giga cells per liter | Standard Deviation 1.0808 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Eosinophils,Week 20,n=25,22,18,17,16 | 0.057 Giga cells per liter | Standard Deviation 0.0637 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 48,n=9,8,4,8,5 | -0.510 Giga cells per liter | Standard Deviation 1.145 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Lymphocytes,Week 2,n=37,36,24,23,25 | -0.209 Giga cells per liter | Standard Deviation 0.9381 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets | Leukocytes,Week 52,n=8,5,5,5,4 | -3.10 Giga cells per liter | Standard Deviation 4.09 |
Secondary
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 44,n=8,8,4,5,8 | 12.5 Grams per liter | Standard Deviation 7.17 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 12,n=31,28,23,22,22 | 5.8 Grams per liter | Standard Deviation 7.85 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 48,n=6,7,2,6,4 | 13.3 Grams per liter | Standard Deviation 9.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 8,n=34,29,23,22,21 | 5.9 Grams per liter | Standard Deviation 9.57 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 52,n=6,4,3,4,3 | 16.5 Grams per liter | Standard Deviation 5.47 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 44,n=11,10,6,8,9 | 0.0 Grams per liter | Standard Deviation 8 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 4,n=36,37,24,22,27 | 3.0 Grams per liter | Standard Deviation 6.37 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 2,n=38,39,24,24,25 | 1.2 Grams per liter | Standard Deviation 6.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 12,n=25,23,18,20,20 | 6.5 Grams per liter | Standard Deviation 9.77 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 52,n=8,5,5,5,4 | 2.9 Grams per liter | Standard Deviation 5.33 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 2,n=32,33,18,22,23 | -0.5 Grams per liter | Standard Deviation 6.21 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 16,n=22,21,17,17,17 | 8.3 Grams per liter | Standard Deviation 9.8 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 4,n=31,31,19,20,25 | 1.6 Grams per liter | Standard Deviation 7.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 40,n=14,11,8,10,10 | 1.3 Grams per liter | Standard Deviation 8.03 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 20,n=19,18,14,16,14 | 7.7 Grams per liter | Standard Deviation 8.43 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 36,n=15,12,10,12,12 | 4.4 Grams per liter | Standard Deviation 7.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 24,n=16,16,13,15,14 | 4.7 Grams per liter | Standard Deviation 7.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 32,n=19,15,10,12,13 | 0.9 Grams per liter | Standard Deviation 9.04 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 28,n=13,14,10,12,11 | 4.5 Grams per liter | Standard Deviation 7.78 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 28,n=18,18,12,14,13 | 0.3 Grams per liter | Standard Deviation 9.68 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 32,n=13,11,8,10,11 | 6.9 Grams per liter | Standard Deviation 9.33 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 48,n=9,8,4,8,5 | 2.4 Grams per liter | Standard Deviation 7.57 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 24,n=22,21,16,16,16 | 2.2 Grams per liter | Standard Deviation 8.67 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 36,n=10,10,8,10,10 | 6.9 Grams per liter | Standard Deviation 5.11 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 8,n=28,24,18,20,20 | 6.1 Grams per liter | Standard Deviation 8.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 20,n=25,23,18,18,16 | 2.0 Grams per liter | Standard Deviation 7.89 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 40,n=10,9,7,8,9 | 11.5 Grams per liter | Standard Deviation 9.89 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 16,n=27,26,21,19,19 | 2.6 Grams per liter | Standard Deviation 6 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 12,n=31,28,23,22,22 | 8.4 Grams per liter | Standard Deviation 10.62 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 52,n=8,5,5,5,4 | 8.6 Grams per liter | Standard Deviation 12.84 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 32,n=19,15,10,12,13 | 5.1 Grams per liter | Standard Deviation 10.88 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 8,n=34,29,23,22,21 | 4.7 Grams per liter | Standard Deviation 9.59 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 20,n=25,23,18,18,16 | 7.4 Grams per liter | Standard Deviation 9.69 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 48,n=6,7,2,6,4 | 11.9 Grams per liter | Standard Deviation 9.84 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 44,n=11,10,6,8,9 | 6.7 Grams per liter | Standard Deviation 14.6 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 24,n=16,16,13,15,14 | 14.6 Grams per liter | Standard Deviation 11.04 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 4,n=36,37,24,22,27 | 2.8 Grams per liter | Standard Deviation 8.17 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 2,n=32,33,18,22,23 | 0.1 Grams per liter | Standard Deviation 9.47 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 52,n=6,4,3,4,3 | 18.8 Grams per liter | Standard Deviation 5.68 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 40,n=10,9,7,8,9 | 11.3 Grams per liter | Standard Deviation 7.75 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 28,n=18,18,12,14,13 | 5.8 Grams per liter | Standard Deviation 11.83 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 2,n=38,39,24,24,25 | 2.5 Grams per liter | Standard Deviation 6.85 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 36,n=10,10,8,10,10 | 6.7 Grams per liter | Standard Deviation 9.72 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 28,n=13,14,10,12,11 | 9.2 Grams per liter | Standard Deviation 11.52 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 12,n=25,23,18,20,20 | 6.7 Grams per liter | Standard Deviation 9.03 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 48,n=9,8,4,8,5 | 4.8 Grams per liter | Standard Deviation 12.62 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 8,n=28,24,18,20,20 | 6.7 Grams per liter | Standard Deviation 10.98 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 40,n=14,11,8,10,10 | 3.8 Grams per liter | Standard Deviation 12.4 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 24,n=22,21,16,16,16 | 7.0 Grams per liter | Standard Deviation 9.99 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 16,n=22,21,17,17,17 | 8.9 Grams per liter | Standard Deviation 12.41 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 44,n=8,8,4,5,8 | 9.9 Grams per liter | Standard Deviation 9.86 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 32,n=13,11,8,10,11 | 8.4 Grams per liter | Standard Deviation 10.45 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 36,n=15,12,10,12,12 | 4.8 Grams per liter | Standard Deviation 11.91 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 16,n=27,26,21,19,19 | 5.8 Grams per liter | Standard Deviation 8.87 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 20,n=19,18,14,16,14 | 10.8 Grams per liter | Standard Deviation 9.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 4,n=31,31,19,20,25 | 2.3 Grams per liter | Standard Deviation 11.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 40,n=14,11,8,10,10 | 6.3 Grams per liter | Standard Deviation 5.47 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 2,n=32,33,18,22,23 | 1.9 Grams per liter | Standard Deviation 5.11 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 4,n=31,31,19,20,25 | 2.6 Grams per liter | Standard Deviation 9.46 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 8,n=28,24,18,20,20 | 6.4 Grams per liter | Standard Deviation 9.09 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 12,n=25,23,18,20,20 | 5.9 Grams per liter | Standard Deviation 14.2 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 16,n=22,21,17,17,17 | 10.2 Grams per liter | Standard Deviation 8.5 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 20,n=19,18,14,16,14 | 9.0 Grams per liter | Standard Deviation 8.6 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 24,n=16,16,13,15,14 | 4.9 Grams per liter | Standard Deviation 9.97 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 28,n=13,14,10,12,11 | 8.9 Grams per liter | Standard Deviation 11.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 32,n=13,11,8,10,11 | 8.8 Grams per liter | Standard Deviation 9.05 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 36,n=10,10,8,10,10 | 13.5 Grams per liter | Standard Deviation 8.07 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 40,n=10,9,7,8,9 | 14.4 Grams per liter | Standard Deviation 12.45 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 44,n=8,8,4,5,8 | 13.5 Grams per liter | Standard Deviation 4.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 48,n=6,7,2,6,4 | 10.5 Grams per liter | Standard Deviation 13.44 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 52,n=6,4,3,4,3 | 24.0 Grams per liter | Standard Deviation 3.46 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 2,n=38,39,24,24,25 | 1.3 Grams per liter | Standard Deviation 8.72 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 4,n=36,37,24,22,27 | 2.5 Grams per liter | Standard Deviation 6.55 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 8,n=34,29,23,22,21 | 3.1 Grams per liter | Standard Deviation 7 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 12,n=31,28,23,22,22 | 4.7 Grams per liter | Standard Deviation 6.24 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 16,n=27,26,21,19,19 | 4.2 Grams per liter | Standard Deviation 7.03 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 20,n=25,23,18,18,16 | 3.3 Grams per liter | Standard Deviation 5.58 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 24,n=22,21,16,16,16 | 5.4 Grams per liter | Standard Deviation 6.38 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 28,n=18,18,12,14,13 | 2.8 Grams per liter | Standard Deviation 6.92 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 32,n=19,15,10,12,13 | 2.0 Grams per liter | Standard Deviation 9.42 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 36,n=15,12,10,12,12 | 4.0 Grams per liter | Standard Deviation 7.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 44,n=11,10,6,8,9 | 2.3 Grams per liter | Standard Deviation 7.84 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 48,n=9,8,4,8,5 | 2.8 Grams per liter | Standard Deviation 12.69 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 52,n=8,5,5,5,4 | 10.4 Grams per liter | Standard Deviation 13.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 20,n=25,23,18,18,16 | -4.6 Grams per liter | Standard Deviation 11.32 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 32,n=19,15,10,12,13 | -3.0 Grams per liter | Standard Deviation 10.05 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 12,n=31,28,23,22,22 | -3.2 Grams per liter | Standard Deviation 11.11 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 20,n=19,18,14,16,14 | 3.4 Grams per liter | Standard Deviation 10.38 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 32,n=13,11,8,10,11 | 6.7 Grams per liter | Standard Deviation 8.88 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 2,n=32,33,18,22,23 | -1.1 Grams per liter | Standard Deviation 6.56 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 36,n=15,12,10,12,12 | -2.6 Grams per liter | Standard Deviation 10.93 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 4,n=31,31,19,20,25 | 0.1 Grams per liter | Standard Deviation 5.17 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 16,n=22,21,17,17,17 | 0.9 Grams per liter | Standard Deviation 11.52 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 48,n=9,8,4,8,5 | -4.6 Grams per liter | Standard Deviation 14.66 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 12,n=25,23,18,20,20 | 1.3 Grams per liter | Standard Deviation 9.55 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 40,n=14,11,8,10,10 | -3.4 Grams per liter | Standard Deviation 11.24 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 24,n=22,21,16,16,16 | -3.1 Grams per liter | Standard Deviation 12.05 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 16,n=27,26,21,19,19 | -3.8 Grams per liter | Standard Deviation 10.55 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 8,n=28,24,18,20,20 | 0.6 Grams per liter | Standard Deviation 9.53 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 28,n=13,14,10,12,11 | 2.8 Grams per liter | Standard Deviation 13.57 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 44,n=8,8,4,5,8 | 5.2 Grams per liter | Standard Deviation 4.6 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 2,n=38,39,24,24,25 | -2.4 Grams per liter | Standard Deviation 7.08 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 36,n=10,10,8,10,10 | 7.9 Grams per liter | Standard Deviation 11.44 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 52,n=6,4,3,4,3 | 11.3 Grams per liter | Standard Deviation 5.06 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 28,n=18,18,12,14,13 | -4.4 Grams per liter | Standard Deviation 11.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 44,n=11,10,6,8,9 | -0.3 Grams per liter | Standard Deviation 11.7 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 4,n=36,37,24,22,27 | -1.0 Grams per liter | Standard Deviation 8.45 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 40,n=10,9,7,8,9 | 5.1 Grams per liter | Standard Deviation 15.3 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 48,n=6,7,2,6,4 | 3.8 Grams per liter | Standard Deviation 11.48 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 24,n=16,16,13,15,14 | 3.0 Grams per liter | Standard Deviation 7.46 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 52,n=8,5,5,5,4 | 4.4 Grams per liter | Standard Deviation 6.47 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 8,n=34,29,23,22,21 | -1.4 Grams per liter | Standard Deviation 10.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 48,n=6,7,2,6,4 | 9.3 Grams per liter | Standard Deviation 9.32 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 40,n=10,9,7,8,9 | 13.9 Grams per liter | Standard Deviation 12.39 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 4,n=31,31,19,20,25 | 2.4 Grams per liter | Standard Deviation 9.32 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 12,n=31,28,23,22,22 | -1.4 Grams per liter | Standard Deviation 7.1 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 36,n=10,10,8,10,10 | 4.2 Grams per liter | Standard Deviation 5.9 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 16,n=27,26,21,19,19 | -1.7 Grams per liter | Standard Deviation 7.47 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 32,n=13,11,8,10,11 | 1.4 Grams per liter | Standard Deviation 8.58 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 20,n=25,23,18,18,16 | -0.6 Grams per liter | Standard Deviation 6.22 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 28,n=13,14,10,12,11 | -0.4 Grams per liter | Standard Deviation 7.86 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 24,n=22,21,16,16,16 | -0.9 Grams per liter | Standard Deviation 6.43 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 24,n=16,16,13,15,14 | 4.9 Grams per liter | Standard Deviation 11.49 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 48,n=9,8,4,8,5 | 7.6 Grams per liter | Standard Deviation 15.57 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 28,n=18,18,12,14,13 | -1.5 Grams per liter | Standard Deviation 8.88 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 20,n=19,18,14,16,14 | 4.6 Grams per liter | Standard Deviation 12.48 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 2,n=32,33,18,22,23 | 1.2 Grams per liter | Standard Deviation 8.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 32,n=19,15,10,12,13 | 0.8 Grams per liter | Standard Deviation 9.64 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 16,n=22,21,17,17,17 | 4.5 Grams per liter | Standard Deviation 9.62 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 36,n=15,12,10,12,12 | 1.3 Grams per liter | Standard Deviation 9.68 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 12,n=25,23,18,20,20 | 4.9 Grams per liter | Standard Deviation 7.81 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 40,n=14,11,8,10,10 | -0.4 Grams per liter | Standard Deviation 7.86 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 8,n=28,24,18,20,20 | 6.7 Grams per liter | Standard Deviation 8.19 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 52,n=6,4,3,4,3 | 5.0 Grams per liter | Standard Deviation 9.85 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 52,n=8,5,5,5,4 | 2.8 Grams per liter | Standard Deviation 13.57 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 2,n=38,39,24,24,25 | -0.9 Grams per liter | Standard Deviation 5.44 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 8,n=34,29,23,22,21 | -2.8 Grams per liter | Standard Deviation 7.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 4,n=36,37,24,22,27 | -2.1 Grams per liter | Standard Deviation 6.86 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | MCHC,Week 44,n=8,8,4,5,8 | 12.1 Grams per liter | Standard Deviation 10.99 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin | Hemoglobin,Week 44,n=11,10,6,8,9 | 2.8 Grams per liter | Standard Deviation 12.85 |
Secondary
Part A: Change From Baseline in Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 48,n=9,8,5,8,5 | -8.2 Beats per minute | Standard Deviation 7.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 12,n=32,29,23,22,22 | -3.8 Beats per minute | Standard Deviation 8.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 36,n=15,13,10,12,13 | -5.9 Beats per minute | Standard Deviation 9.79 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 2, ,n=37,39,25,24,27 | -1.9 Beats per minute | Standard Deviation 8.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 16,n=28,26,22,19,19 | -3.4 Beats per minute | Standard Deviation 10.79 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 32,n=19,15,10,12,13 | -1.3 Beats per minute | Standard Deviation 8.2 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 8,n=34,32,24,22,23 | -1.1 Beats per minute | Standard Deviation 10.23 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 40,n=15,11,9,10,10 | -3.9 Beats per minute | Standard Deviation 5.64 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 52,n=9,5,5,5,4 | -5.0 Beats per minute | Standard Deviation 12.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 20,n=26,23,19,18,16 | -3.0 Beats per minute | Standard Deviation 9.75 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 24,n=23,21,16,17,16 | -2.1 Beats per minute | Standard Deviation 9.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 4,n=37,37,25,22,27 | 0.2 Beats per minute | Standard Deviation 8.82 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 44,n=11,11,6,8,9 | -7.1 Beats per minute | Standard Deviation 8.01 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 28,n=19,18,12,14,14 | -1.4 Beats per minute | Standard Deviation 10.33 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 44,n=11,11,6,8,9 | -3.4 Beats per minute | Standard Deviation 15.86 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 2, ,n=37,39,25,24,27 | -2.1 Beats per minute | Standard Deviation 8.93 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 48,n=9,8,5,8,5 | -9.3 Beats per minute | Standard Deviation 8.76 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 28,n=19,18,12,14,14 | -1.2 Beats per minute | Standard Deviation 9.21 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 52,n=9,5,5,5,4 | -11.0 Beats per minute | Standard Deviation 3.74 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 24,n=23,21,16,17,16 | -3.5 Beats per minute | Standard Deviation 11.18 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 16,n=28,26,22,19,19 | 0.3 Beats per minute | Standard Deviation 9.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 32,n=19,15,10,12,13 | -4.7 Beats per minute | Standard Deviation 8.5 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 12,n=32,29,23,22,22 | -1.2 Beats per minute | Standard Deviation 13.62 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 36,n=15,13,10,12,13 | -5.1 Beats per minute | Standard Deviation 9.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 20,n=26,23,19,18,16 | 0.2 Beats per minute | Standard Deviation 11.35 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 8,n=34,32,24,22,23 | -3.2 Beats per minute | Standard Deviation 11.42 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 40,n=15,11,9,10,10 | -3.0 Beats per minute | Standard Deviation 11.93 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 4,n=37,37,25,22,27 | -1.4 Beats per minute | Standard Deviation 8.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 8,n=34,32,24,22,23 | -3.1 Beats per minute | Standard Deviation 8.8 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 24,n=23,21,16,17,16 | 0.7 Beats per minute | Standard Deviation 14.13 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 28,n=19,18,12,14,14 | -3.5 Beats per minute | Standard Deviation 13.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 32,n=19,15,10,12,13 | -2.2 Beats per minute | Standard Deviation 10.78 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 36,n=15,13,10,12,13 | -4.5 Beats per minute | Standard Deviation 9.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 40,n=15,11,9,10,10 | -3.4 Beats per minute | Standard Deviation 10.57 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 44,n=11,11,6,8,9 | -8.3 Beats per minute | Standard Deviation 13.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 48,n=9,8,5,8,5 | -7.2 Beats per minute | Standard Deviation 10.47 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 52,n=9,5,5,5,4 | -4.0 Beats per minute | Standard Deviation 15.89 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 2, ,n=37,39,25,24,27 | 1.8 Beats per minute | Standard Deviation 10.4 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 4,n=37,37,25,22,27 | -2.4 Beats per minute | Standard Deviation 9.42 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 12,n=32,29,23,22,22 | -0.8 Beats per minute | Standard Deviation 8.35 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 16,n=28,26,22,19,19 | -5.3 Beats per minute | Standard Deviation 10.32 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 20,n=26,23,19,18,16 | -0.7 Beats per minute | Standard Deviation 12.62 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 2, ,n=37,39,25,24,27 | -0.4 Beats per minute | Standard Deviation 12.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 32,n=19,15,10,12,13 | -0.8 Beats per minute | Standard Deviation 16.1 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 24,n=23,21,16,17,16 | 0.1 Beats per minute | Standard Deviation 12.76 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 12,n=32,29,23,22,22 | 4.5 Beats per minute | Standard Deviation 14.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 36,n=15,13,10,12,13 | -0.5 Beats per minute | Standard Deviation 12.22 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 4,n=37,37,25,22,27 | 2.2 Beats per minute | Standard Deviation 13.39 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 28,n=19,18,12,14,14 | 0.1 Beats per minute | Standard Deviation 13.24 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 20,n=26,23,19,18,16 | 1.0 Beats per minute | Standard Deviation 13.76 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 8,n=34,32,24,22,23 | 4.3 Beats per minute | Standard Deviation 12.36 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 48,n=9,8,5,8,5 | -1.9 Beats per minute | Standard Deviation 11.47 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 16,n=28,26,22,19,19 | 0.3 Beats per minute | Standard Deviation 15.04 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 52,n=9,5,5,5,4 | 6.8 Beats per minute | Standard Deviation 6.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 40,n=15,11,9,10,10 | 3.3 Beats per minute | Standard Deviation 12.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 44,n=11,11,6,8,9 | 4.3 Beats per minute | Standard Deviation 15.34 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 44,n=11,11,6,8,9 | -3.4 Beats per minute | Standard Deviation 8.57 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 16,n=28,26,22,19,19 | -2.2 Beats per minute | Standard Deviation 10.76 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 2, ,n=37,39,25,24,27 | -1.6 Beats per minute | Standard Deviation 9.79 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 40,n=15,11,9,10,10 | -3.8 Beats per minute | Standard Deviation 14.09 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 24,n=23,21,16,17,16 | 2.7 Beats per minute | Standard Deviation 8.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 4,n=37,37,25,22,27 | -1.9 Beats per minute | Standard Deviation 10.33 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 36,n=15,13,10,12,13 | -3.2 Beats per minute | Standard Deviation 9.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 20,n=26,23,19,18,16 | -4.0 Beats per minute | Standard Deviation 12.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 8,n=34,32,24,22,23 | 0.5 Beats per minute | Standard Deviation 11.06 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 32,n=19,15,10,12,13 | -0.6 Beats per minute | Standard Deviation 12.58 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 12,n=32,29,23,22,22 | -2.7 Beats per minute | Standard Deviation 10.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 28,n=19,18,12,14,14 | 0.5 Beats per minute | Standard Deviation 10.6 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 48,n=9,8,5,8,5 | 0.0 Beats per minute | Standard Deviation 16.72 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Pulse Rate | Week 52,n=9,5,5,5,4 | -5.3 Beats per minute | Standard Deviation 12.04 |
Secondary
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 2,n=38,39,26,24,26 | -5.07 Milligrams per liter | Standard Deviation 6.616 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 32,n=19,15,10,12,13 | -4.85 Milligrams per liter | Standard Deviation 7.259 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 24,n=23,20,16,17,16 | -4.38 Milligrams per liter | Standard Deviation 4.64 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 28,n=19,18,12,14,14 | -5.28 Milligrams per liter | Standard Deviation 6.498 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 48,n=9,7,5,8,5 | -5.91 Milligrams per liter | Standard Deviation 4.993 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 8,n=34,31,24,22,23 | -4.98 Milligrams per liter | Standard Deviation 6.583 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 44,n=11,11,6,8,9 | -5.35 Milligrams per liter | Standard Deviation 4.523 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 12,n=32,28,24,21,21 | -5.08 Milligrams per liter | Standard Deviation 6.69 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 52,n=9,5,5,5,4 | -6.00 Milligrams per liter | Standard Deviation 4.663 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 40,n=15,11,8,10,10 | -4.72 Milligrams per liter | Standard Deviation 4.374 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 16,n=28,26,22,19,18 | -4.35 Milligrams per liter | Standard Deviation 5.648 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 4,n=37,38,25,23,27 | -4.39 Milligrams per liter | Standard Deviation 6.384 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 36,n=15,12,10,12,13 | -4.72 Milligrams per liter | Standard Deviation 4.473 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 20,n=26,23,19,18,16 | -4.50 Milligrams per liter | Standard Deviation 5.876 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 20,n=26,23,19,18,16 | -11.67 Milligrams per liter | Standard Deviation 29.422 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 16,n=28,26,22,19,18 | -10.43 Milligrams per liter | Standard Deviation 27.765 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 12,n=32,28,24,21,21 | -9.96 Milligrams per liter | Standard Deviation 26.849 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 24,n=23,20,16,17,16 | -13.19 Milligrams per liter | Standard Deviation 31.269 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 4,n=37,38,25,23,27 | -9.01 Milligrams per liter | Standard Deviation 23.327 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 28,n=19,18,12,14,14 | -13.42 Milligrams per liter | Standard Deviation 33.182 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 32,n=19,15,10,12,13 | -14.47 Milligrams per liter | Standard Deviation 36.343 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 2,n=38,39,26,24,26 | -8.81 Milligrams per liter | Standard Deviation 22.954 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 48,n=9,7,5,8,5 | -23.39 Milligrams per liter | Standard Deviation 52.962 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 40,n=15,11,8,10,10 | -17.67 Milligrams per liter | Standard Deviation 42.24 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 36,n=15,12,10,12,13 | -16.28 Milligrams per liter | Standard Deviation 40.531 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 8,n=34,31,24,22,23 | -9.94 Milligrams per liter | Standard Deviation 25.685 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 52,n=9,5,5,5,4 | -7.26 Milligrams per liter | Standard Deviation 9.461 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 44,n=11,11,6,8,9 | -17.47 Milligrams per liter | Standard Deviation 42.35 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 20,n=26,23,19,18,16 | -4.78 Milligrams per liter | Standard Deviation 8.1 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 2,n=38,39,26,24,26 | -5.15 Milligrams per liter | Standard Deviation 8.436 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 4,n=37,38,25,23,27 | -4.09 Milligrams per liter | Standard Deviation 7.169 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 8,n=34,31,24,22,23 | -4.19 Milligrams per liter | Standard Deviation 7.197 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 12,n=32,28,24,21,21 | -4.22 Milligrams per liter | Standard Deviation 7.335 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 16,n=28,26,22,19,18 | -4.48 Milligrams per liter | Standard Deviation 7.621 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 24,n=23,20,16,17,16 | -5.14 Milligrams per liter | Standard Deviation 8.837 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 28,n=19,18,12,14,14 | -6.33 Milligrams per liter | Standard Deviation 10.022 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 32,n=19,15,10,12,13 | -7.15 Milligrams per liter | Standard Deviation 10.875 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 36,n=15,12,10,12,13 | -7.08 Milligrams per liter | Standard Deviation 10.874 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 40,n=15,11,8,10,10 | -4.69 Milligrams per liter | Standard Deviation 8.51 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 44,n=11,11,6,8,9 | -1.90 Milligrams per liter | Standard Deviation 1.456 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 48,n=9,7,5,8,5 | -2.20 Milligrams per liter | Standard Deviation 1.562 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 52,n=9,5,5,5,4 | -2.20 Milligrams per liter | Standard Deviation 1.575 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 20,n=26,23,19,18,16 | 5.32 Milligrams per liter | Standard Deviation 14.506 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 32,n=19,15,10,12,13 | 2.61 Milligrams per liter | Standard Deviation 9.835 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 16,n=28,26,22,19,18 | 10.53 Milligrams per liter | Standard Deviation 17.303 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 36,n=15,12,10,12,13 | 5.73 Milligrams per liter | Standard Deviation 19.04 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 12,n=32,28,24,21,21 | 14.81 Milligrams per liter | Standard Deviation 18.082 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 2,n=38,39,26,24,26 | 1.27 Milligrams per liter | Standard Deviation 13.155 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 40,n=15,11,8,10,10 | 6.27 Milligrams per liter | Standard Deviation 21.164 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 8,n=34,31,24,22,23 | 10.00 Milligrams per liter | Standard Deviation 14.652 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 44,n=11,11,6,8,9 | 2.80 Milligrams per liter | Standard Deviation 20.439 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 4,n=37,38,25,23,27 | 4.91 Milligrams per liter | Standard Deviation 10.503 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 52,n=9,5,5,5,4 | 0.64 Milligrams per liter | Standard Deviation 9.453 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 24,n=23,20,16,17,16 | 5.07 Milligrams per liter | Standard Deviation 13.815 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 48,n=9,7,5,8,5 | 6.31 Milligrams per liter | Standard Deviation 20.952 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 28,n=19,18,12,14,14 | 1.87 Milligrams per liter | Standard Deviation 10.926 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 24,n=23,20,16,17,16 | 6.54 Milligrams per liter | Standard Deviation 20.711 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 52,n=9,5,5,5,4 | -1.65 Milligrams per liter | Standard Deviation 4.561 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 32,n=19,15,10,12,13 | 4.37 Milligrams per liter | Standard Deviation 16.277 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 16,n=28,26,22,19,18 | 6.99 Milligrams per liter | Standard Deviation 15.503 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 28,n=19,18,12,14,14 | 0.22 Milligrams per liter | Standard Deviation 11.318 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 2,n=38,39,26,24,26 | 1.07 Milligrams per liter | Standard Deviation 6.794 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 44,n=11,11,6,8,9 | 5.13 Milligrams per liter | Standard Deviation 7.292 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 36,n=15,12,10,12,13 | 1.64 Milligrams per liter | Standard Deviation 10.418 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 12,n=32,28,24,21,21 | 4.04 Milligrams per liter | Standard Deviation 9.339 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 4,n=37,38,25,23,27 | 0.76 Milligrams per liter | Standard Deviation 5.511 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 20,n=26,23,19,18,16 | 2.35 Milligrams per liter | Standard Deviation 7.84 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 48,n=9,7,5,8,5 | 8.10 Milligrams per liter | Standard Deviation 18.084 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 40,n=15,11,8,10,10 | 2.77 Milligrams per liter | Standard Deviation 13.101 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time | Week 8,n=34,31,24,22,23 | 7.86 Milligrams per liter | Standard Deviation 25.894 |
Secondary
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)..
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 44,n=11,11,6,8,9 | -12.7 Millimeters of mercury | Standard Deviation 17.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 12,n=32,29,24,22,22 | 1.0 Millimeters of mercury | Standard Deviation 9.6 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 48,n=9,8,5,8,5 | -13.6 Millimeters of mercury | Standard Deviation 11.85 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 8,n=34,32,24,22,23 | 2.1 Millimeters of mercury | Standard Deviation 8.47 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 52,n=9,5,5,5,4 | -8.1 Millimeters of mercury | Standard Deviation 15.85 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 44,n=11,11,6,8,9 | -2.7 Millimeters of mercury | Standard Deviation 12.1 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 4,n=37,37,25,23,27 | 1.8 Millimeters of mercury | Standard Deviation 8.85 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 2,n=37,39,26,24,27 | 0.3 Millimeters of mercury | Standard Deviation 7.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 12,n=32,29,24,22,22 | -2.3 Millimeters of mercury | Standard Deviation 15.19 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 52,n=9,5,5,5,4 | 0.2 Millimeters of mercury | Standard Deviation 12.55 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 2,n=37,39,26,24,27 | -0.9 Millimeters of mercury | Standard Deviation 13.11 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 16,n=28,26,22,19,19 | -6.0 Millimeters of mercury | Standard Deviation 15.39 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 4,n=37,37,25,23,27 | -0.9 Millimeters of mercury | Standard Deviation 15.17 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 40,n=15,11,9,10,10 | -6.9 Millimeters of mercury | Standard Deviation 12.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 20,n=26,23,19,18,16 | -6.7 Millimeters of mercury | Standard Deviation 10.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 36,n=15,13,10,12,13 | -0.6 Millimeters of mercury | Standard Deviation 8.92 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 24,n=23,21,16,17,16 | -5.2 Millimeters of mercury | Standard Deviation 12.65 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 32,n=19,15,10,12,13 | -4.2 Millimeters of mercury | Standard Deviation 7.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 28,n=19,18,12,14,14 | -8.8 Millimeters of mercury | Standard Deviation 12.87 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 28,n=19,18,12,14,14 | -3.1 Millimeters of mercury | Standard Deviation 9.39 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 32,n=19,15,10,12,13 | -10.7 Millimeters of mercury | Standard Deviation 13.96 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 48,n=9,8,5,8,5 | -5.6 Millimeters of mercury | Standard Deviation 11.79 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 24,n=23,21,16,17,16 | 1.3 Millimeters of mercury | Standard Deviation 8.72 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 36,n=15,13,10,12,13 | -6.2 Millimeters of mercury | Standard Deviation 13.92 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 8,n=34,32,24,22,23 | 0.3 Millimeters of mercury | Standard Deviation 14.33 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 20,n=26,23,19,18,16 | -0.9 Millimeters of mercury | Standard Deviation 7.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 40,n=15,11,9,10,10 | -11.9 Millimeters of mercury | Standard Deviation 11.75 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 16,n=28,26,22,19,19 | 0.2 Millimeters of mercury | Standard Deviation 7.48 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 12,n=32,29,24,22,22 | 2.0 Millimeters of mercury | Standard Deviation 12.35 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 52,n=9,5,5,5,4 | 1.8 Millimeters of mercury | Standard Deviation 10.23 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 32,n=19,15,10,12,13 | -2.3 Millimeters of mercury | Standard Deviation 12.92 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 8,n=34,32,24,22,23 | -1.3 Millimeters of mercury | Standard Deviation 7.62 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 20,n=26,23,19,18,16 | 1.4 Millimeters of mercury | Standard Deviation 12.47 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 48,n=9,8,5,8,5 | -0.4 Millimeters of mercury | Standard Deviation 9.44 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 44,n=11,11,6,8,9 | -6.5 Millimeters of mercury | Standard Deviation 14.56 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 24,n=23,21,16,17,16 | -2.5 Millimeters of mercury | Standard Deviation 15.46 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 4,n=37,37,25,23,27 | 1.5 Millimeters of mercury | Standard Deviation 10.24 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 2,n=37,39,26,24,27 | 3.5 Millimeters of mercury | Standard Deviation 13.97 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 52,n=9,5,5,5,4 | 1.2 Millimeters of mercury | Standard Deviation 14.46 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 40,n=15,11,9,10,10 | 0.9 Millimeters of mercury | Standard Deviation 13.14 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 28,n=19,18,12,14,14 | -2.2 Millimeters of mercury | Standard Deviation 10.05 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 2,n=37,39,26,24,27 | 1.2 Millimeters of mercury | Standard Deviation 10.05 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 36,n=15,13,10,12,13 | -8.0 Millimeters of mercury | Standard Deviation 15.8 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 28,n=19,18,12,14,14 | -4.2 Millimeters of mercury | Standard Deviation 20.49 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 12,n=32,29,24,22,22 | -2.4 Millimeters of mercury | Standard Deviation 17.15 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 48,n=9,8,5,8,5 | -2.3 Millimeters of mercury | Standard Deviation 11.42 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 8,n=34,32,24,22,23 | -3.9 Millimeters of mercury | Standard Deviation 17.17 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 40,n=15,11,9,10,10 | 2.6 Millimeters of mercury | Standard Deviation 11.88 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 24,n=23,21,16,17,16 | -0.6 Millimeters of mercury | Standard Deviation 12.85 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 16,n=28,26,22,19,19 | -5.1 Millimeters of mercury | Standard Deviation 18.28 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 44,n=11,11,6,8,9 | -4.2 Millimeters of mercury | Standard Deviation 19.22 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 32,n=19,15,10,12,13 | -3.7 Millimeters of mercury | Standard Deviation 15.03 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 36,n=15,13,10,12,13 | -5.1 Millimeters of mercury | Standard Deviation 9.89 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 16,n=28,26,22,19,19 | -2.5 Millimeters of mercury | Standard Deviation 11.58 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 20,n=26,23,19,18,16 | -0.7 Millimeters of mercury | Standard Deviation 14.09 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 4,n=37,37,25,23,27 | 0.2 Millimeters of mercury | Standard Deviation 15.99 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 40,n=15,11,9,10,10 | -8.0 Millimeters of mercury | Standard Deviation 21.6 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 2,n=37,39,26,24,27 | -2.1 Millimeters of mercury | Standard Deviation 17.19 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 4,n=37,37,25,23,27 | -4.7 Millimeters of mercury | Standard Deviation 15 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 8,n=34,32,24,22,23 | -3.5 Millimeters of mercury | Standard Deviation 15.73 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 12,n=32,29,24,22,22 | -6.2 Millimeters of mercury | Standard Deviation 13.45 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 16,n=28,26,22,19,19 | -3.0 Millimeters of mercury | Standard Deviation 20.22 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 20,n=26,23,19,18,16 | -3.4 Millimeters of mercury | Standard Deviation 15.39 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 24,n=23,21,16,17,16 | -5.6 Millimeters of mercury | Standard Deviation 16.55 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 28,n=19,18,12,14,14 | -0.1 Millimeters of mercury | Standard Deviation 14.76 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 32,n=19,15,10,12,13 | -7.4 Millimeters of mercury | Standard Deviation 11.8 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 36,n=15,13,10,12,13 | -6.8 Millimeters of mercury | Standard Deviation 12.1 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 40,n=15,11,9,10,10 | -4.8 Millimeters of mercury | Standard Deviation 14.17 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 44,n=11,11,6,8,9 | 2.7 Millimeters of mercury | Standard Deviation 13.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 48,n=9,8,5,8,5 | -3.6 Millimeters of mercury | Standard Deviation 28.13 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 52,n=9,5,5,5,4 | 2.2 Millimeters of mercury | Standard Deviation 19.52 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 2,n=37,39,26,24,27 | -2.3 Millimeters of mercury | Standard Deviation 14 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 4,n=37,37,25,23,27 | -4.1 Millimeters of mercury | Standard Deviation 13.22 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 8,n=34,32,24,22,23 | -4.0 Millimeters of mercury | Standard Deviation 12.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 12,n=32,29,24,22,22 | -4.7 Millimeters of mercury | Standard Deviation 12.14 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 16,n=28,26,22,19,19 | -3.1 Millimeters of mercury | Standard Deviation 12.8 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 20,n=26,23,19,18,16 | -3.2 Millimeters of mercury | Standard Deviation 16.21 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 24,n=23,21,16,17,16 | -2.7 Millimeters of mercury | Standard Deviation 11.77 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 28,n=19,18,12,14,14 | -4.3 Millimeters of mercury | Standard Deviation 15.8 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 32,n=19,15,10,12,13 | -6.9 Millimeters of mercury | Standard Deviation 25.47 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 36,n=15,13,10,12,13 | -5.6 Millimeters of mercury | Standard Deviation 17.02 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 44,n=11,11,6,8,9 | -2.5 Millimeters of mercury | Standard Deviation 23.89 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 48,n=9,8,5,8,5 | -2.0 Millimeters of mercury | Standard Deviation 16 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 52,n=9,5,5,5,4 | 2.2 Millimeters of mercury | Standard Deviation 3.35 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 20,n=26,23,19,18,16 | -2.0 Millimeters of mercury | Standard Deviation 9.06 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 32,n=19,15,10,12,13 | -1.2 Millimeters of mercury | Standard Deviation 11.17 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 12,n=32,29,24,22,22 | 1.3 Millimeters of mercury | Standard Deviation 10.58 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 20,n=26,23,19,18,16 | -1.7 Millimeters of mercury | Standard Deviation 17.16 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 32,n=19,15,10,12,13 | 3.4 Millimeters of mercury | Standard Deviation 14.99 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 2,n=37,39,26,24,27 | 5.7 Millimeters of mercury | Standard Deviation 12.67 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 36,n=15,13,10,12,13 | -1.2 Millimeters of mercury | Standard Deviation 13.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 4,n=37,37,25,23,27 | -2.2 Millimeters of mercury | Standard Deviation 14.6 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 16,n=28,26,22,19,19 | 1.9 Millimeters of mercury | Standard Deviation 17.51 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 48,n=9,8,5,8,5 | -3.4 Millimeters of mercury | Standard Deviation 12.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 12,n=32,29,24,22,22 | 1.4 Millimeters of mercury | Standard Deviation 12.97 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 40,n=15,11,9,10,10 | -2.0 Millimeters of mercury | Standard Deviation 14.07 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 24,n=23,21,16,17,16 | -3.3 Millimeters of mercury | Standard Deviation 10.21 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 16,n=28,26,22,19,19 | -1.3 Millimeters of mercury | Standard Deviation 10.64 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 8,n=34,32,24,22,23 | -0.8 Millimeters of mercury | Standard Deviation 18.94 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 28,n=19,18,12,14,14 | 6.4 Millimeters of mercury | Standard Deviation 19.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 44,n=11,11,6,8,9 | 2.9 Millimeters of mercury | Standard Deviation 15.99 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 2,n=37,39,26,24,27 | 2.4 Millimeters of mercury | Standard Deviation 9.85 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 36,n=15,13,10,12,13 | -0.6 Millimeters of mercury | Standard Deviation 20.46 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 52,n=9,5,5,5,4 | 2.2 Millimeters of mercury | Standard Deviation 18.46 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 28,n=19,18,12,14,14 | 0.1 Millimeters of mercury | Standard Deviation 13.87 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 44,n=11,11,6,8,9 | -1.5 Millimeters of mercury | Standard Deviation 8.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 4,n=37,37,25,23,27 | 0.1 Millimeters of mercury | Standard Deviation 11.66 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 40,n=15,11,9,10,10 | 2.1 Millimeters of mercury | Standard Deviation 19.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 48,n=9,8,5,8,5 | 8.8 Millimeters of mercury | Standard Deviation 14.15 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 24,n=23,21,16,17,16 | -2.6 Millimeters of mercury | Standard Deviation 18.75 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 52,n=9,5,5,5,4 | 1.4 Millimeters of mercury | Standard Deviation 11.89 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 8,n=34,32,24,22,23 | 2.6 Millimeters of mercury | Standard Deviation 11.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 48,n=9,8,5,8,5 | 4.8 Millimeters of mercury | Standard Deviation 15.51 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 40,n=15,11,9,10,10 | -7.4 Millimeters of mercury | Standard Deviation 20.14 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 4,n=37,37,25,23,27 | -3.4 Millimeters of mercury | Standard Deviation 14.25 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 12,n=32,29,24,22,22 | -2.5 Millimeters of mercury | Standard Deviation 11.16 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 36,n=15,13,10,12,13 | -2.5 Millimeters of mercury | Standard Deviation 16.13 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 16,n=28,26,22,19,19 | -3.4 Millimeters of mercury | Standard Deviation 7.97 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 32,n=19,15,10,12,13 | -8.8 Millimeters of mercury | Standard Deviation 14.8 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 20,n=26,23,19,18,16 | -2.1 Millimeters of mercury | Standard Deviation 10.98 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 28,n=19,18,12,14,14 | -2.6 Millimeters of mercury | Standard Deviation 17.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 24,n=23,21,16,17,16 | -3.1 Millimeters of mercury | Standard Deviation 9.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 24,n=23,21,16,17,16 | -8.6 Millimeters of mercury | Standard Deviation 15.65 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 48,n=9,8,5,8,5 | 0.6 Millimeters of mercury | Standard Deviation 8.47 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 28,n=19,18,12,14,14 | -1.9 Millimeters of mercury | Standard Deviation 10.37 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 20,n=26,23,19,18,16 | -9.4 Millimeters of mercury | Standard Deviation 21.44 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 2,n=37,39,26,24,27 | -0.9 Millimeters of mercury | Standard Deviation 15.63 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 32,n=19,15,10,12,13 | -5.8 Millimeters of mercury | Standard Deviation 9.09 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 16,n=28,26,22,19,19 | -6.4 Millimeters of mercury | Standard Deviation 12.73 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 36,n=15,13,10,12,13 | -2.7 Millimeters of mercury | Standard Deviation 13.05 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 12,n=32,29,24,22,22 | -6.1 Millimeters of mercury | Standard Deviation 19.31 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 40,n=15,11,9,10,10 | -6.1 Millimeters of mercury | Standard Deviation 11.97 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 8,n=34,32,24,22,23 | -8.3 Millimeters of mercury | Standard Deviation 21.05 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 52,n=9,5,5,5,4 | -3.8 Millimeters of mercury | Standard Deviation 12.34 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 52,n=9,5,5,5,4 | 0.5 Millimeters of mercury | Standard Deviation 5.92 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 2,n=37,39,26,24,27 | -2.2 Millimeters of mercury | Standard Deviation 9.22 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 8,n=34,32,24,22,23 | -5.6 Millimeters of mercury | Standard Deviation 11.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 4,n=37,37,25,23,27 | -3.0 Millimeters of mercury | Standard Deviation 10.22 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP,Week 44,n=11,11,6,8,9 | 1.8 Millimeters of mercury | Standard Deviation 13.91 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP,Week 44,n=11,11,6,8,9 | 1.3 Millimeters of mercury | Standard Deviation 11.36 |
Secondary
Part A: Change From Baseline in Temperature
Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 24,n=23,21,16,17,16 | 0.03 Celsius | Standard Deviation 0.389 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 48,n=9,8,5,8,5 | -0.22 Celsius | Standard Deviation 0.233 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 40,n=15,11,9,10,10 | 0.08 Celsius | Standard Deviation 0.426 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 20,n=26,23,19,18,16 | 0.03 Celsius | Standard Deviation 0.428 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 8,n=34,32,23,22,23 | -0.04 Celsius | Standard Deviation 0.4 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 44,n=11,11,6,8,9 | -0.14 Celsius | Standard Deviation 0.347 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 28,n=19,18,12,13,14 | 0.03 Celsius | Standard Deviation 0.444 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 36,n=15,13,9,12,13 | -0.09 Celsius | Standard Deviation 0.406 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 4,n=37,37,25,23,27 | -0.12 Celsius | Standard Deviation 0.345 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 12,n=32,29,24,22,22 | -0.08 Celsius | Standard Deviation 0.461 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 2, ,n=37,39,26,24,27 | -0.11 Celsius | Standard Deviation 0.269 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 52,n=9,5,5,5,4 | -0.08 Celsius | Standard Deviation 0.291 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 32,n=19,15,10,12,13 | -0.01 Celsius | Standard Deviation 0.515 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 16,n=28,26,22,19,19 | -0.08 Celsius | Standard Deviation 0.313 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 28,n=19,18,12,13,14 | -0.07 Celsius | Standard Deviation 0.517 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 16,n=28,26,22,19,19 | -0.05 Celsius | Standard Deviation 0.392 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 24,n=23,21,16,17,16 | -0.11 Celsius | Standard Deviation 0.255 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 20,n=26,23,19,18,16 | -0.05 Celsius | Standard Deviation 0.483 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 2, ,n=37,39,26,24,27 | -0.04 Celsius | Standard Deviation 0.336 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 48,n=9,8,5,8,5 | -0.05 Celsius | Standard Deviation 0.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 40,n=15,11,9,10,10 | -0.03 Celsius | Standard Deviation 0.454 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 52,n=9,5,5,5,4 | -0.32 Celsius | Standard Deviation 0.286 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 4,n=37,37,25,23,27 | 0.01 Celsius | Standard Deviation 0.407 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 36,n=15,13,9,12,13 | -0.11 Celsius | Standard Deviation 0.569 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 8,n=34,32,23,22,23 | -0.09 Celsius | Standard Deviation 0.432 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 44,n=11,11,6,8,9 | -0.06 Celsius | Standard Deviation 0.391 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 32,n=19,15,10,12,13 | -0.07 Celsius | Standard Deviation 0.349 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Change From Baseline in Temperature | Week 12,n=32,29,24,22,22 | -0.11 Celsius | Standard Deviation 0.367 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 44,n=11,11,6,8,9 | -0.03 Celsius | Standard Deviation 0.314 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 52,n=9,5,5,5,4 | 0.14 Celsius | Standard Deviation 0.23 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 48,n=9,8,5,8,5 | -0.14 Celsius | Standard Deviation 0.498 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 2, ,n=37,39,26,24,27 | 0.03 Celsius | Standard Deviation 0.433 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 4,n=37,37,25,23,27 | 0.04 Celsius | Standard Deviation 0.399 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 8,n=34,32,23,22,23 | -0.07 Celsius | Standard Deviation 0.553 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 12,n=32,29,24,22,22 | 0.01 Celsius | Standard Deviation 0.444 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 16,n=28,26,22,19,19 | 0.04 Celsius | Standard Deviation 0.316 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 20,n=26,23,19,18,16 | -0.12 Celsius | Standard Deviation 0.651 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 24,n=23,21,16,17,16 | -0.11 Celsius | Standard Deviation 0.558 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 28,n=19,18,12,13,14 | -0.09 Celsius | Standard Deviation 0.683 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 32,n=19,15,10,12,13 | 0.28 Celsius | Standard Deviation 0.418 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 36,n=15,13,9,12,13 | -0.10 Celsius | Standard Deviation 0.391 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 40,n=15,11,9,10,10 | 0.18 Celsius | Standard Deviation 0.438 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 24,n=23,21,16,17,16 | -0.26 Celsius | Standard Deviation 0.476 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 16,n=28,26,22,19,19 | -0.21 Celsius | Standard Deviation 0.664 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 28,n=19,18,12,13,14 | -0.16 Celsius | Standard Deviation 0.479 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 12,n=32,29,24,22,22 | -0.15 Celsius | Standard Deviation 0.494 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 48,n=9,8,5,8,5 | -0.01 Celsius | Standard Deviation 0.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 32,n=19,15,10,12,13 | -0.13 Celsius | Standard Deviation 0.367 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 8,n=34,32,23,22,23 | 0.04 Celsius | Standard Deviation 0.579 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 52,n=9,5,5,5,4 | 0.02 Celsius | Standard Deviation 0.409 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 36,n=15,13,9,12,13 | -0.09 Celsius | Standard Deviation 0.39 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 4,n=37,37,25,23,27 | -0.10 Celsius | Standard Deviation 0.387 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 40,n=15,11,9,10,10 | -0.05 Celsius | Standard Deviation 0.334 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 2, ,n=37,39,26,24,27 | -0.16 Celsius | Standard Deviation 0.421 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 20,n=26,23,19,18,16 | -0.07 Celsius | Standard Deviation 0.355 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Change From Baseline in Temperature | Week 44,n=11,11,6,8,9 | 0.00 Celsius | Standard Deviation 0.438 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 48,n=9,8,5,8,5 | -0.08 Celsius | Standard Deviation 0.559 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 36,n=15,13,9,12,13 | -0.08 Celsius | Standard Deviation 0.367 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 12,n=32,29,24,22,22 | 0.09 Celsius | Standard Deviation 0.45 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 44,n=11,11,6,8,9 | -0.08 Celsius | Standard Deviation 0.396 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 20,n=26,23,19,18,16 | 0.05 Celsius | Standard Deviation 0.395 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 28,n=19,18,12,13,14 | -0.06 Celsius | Standard Deviation 0.282 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 2, ,n=37,39,26,24,27 | 0.10 Celsius | Standard Deviation 0.449 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 8,n=34,32,23,22,23 | 0.19 Celsius | Standard Deviation 0.425 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 52,n=9,5,5,5,4 | -0.08 Celsius | Standard Deviation 0.814 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 24,n=23,21,16,17,16 | 0.04 Celsius | Standard Deviation 0.441 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 32,n=19,15,10,12,13 | 0.01 Celsius | Standard Deviation 0.364 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 40,n=15,11,9,10,10 | -0.05 Celsius | Standard Deviation 0.306 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 4,n=37,37,25,23,27 | 0.11 Celsius | Standard Deviation 0.34 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Change From Baseline in Temperature | Week 16,n=28,26,22,19,19 | 0.09 Celsius | Standard Deviation 0.317 |
Secondary
Part A: Cumulative Prednisone Dose Over Time
Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 2, n= 40,39,26,27,26 | 439.575 Milligrams | Standard Deviation 237.899 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 32,n=19,21,13,15,18 | 2216.000 Milligrams | Standard Deviation 1953.8211 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 24,n=30,25,19,18,17 | 1878.458 Milligrams | Standard Deviation 1333.1175 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 28,n=24,23,15,17,15 | 2000.813 Milligrams | Standard Deviation 1594.5982 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 48,n=10,16,9,8,11 | 1821.325 Milligrams | Standard Deviation 1139.5986 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 8,n=37, 37,26,23,26 | 1086.676 Milligrams | Standard Deviation 600.74 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 44,n=17,13,10,12,13 | 2051.603 Milligrams | Standard Deviation 1588.9627 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 12,n=34,32,24,22,24 | 1344.441 Milligrams | Standard Deviation 779.6775 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 52,n=11,10,6,7,6 | 2974.295 Milligrams | Standard Deviation 2966.6259 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 40,n=18,15,11,13,12 | 2003.264 Milligrams | Standard Deviation 1426.0271 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 16,n=32,30,24,22,22 | 1545.602 Milligrams | Standard Deviation 964.3264 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 4,n=40,39,26,25,27 | 701.100 Milligrams | Standard Deviation 370.9798 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 36,n=19,17,14,13,14 | 2321.711 Milligrams | Standard Deviation 2090.2393 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 20,n=29,27,21,24,19 | 1690.302 Milligrams | Standard Deviation 1173.6005 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 20,n=29,27,21,24,19 | 1339.546 Milligrams | Standard Deviation 888.5007 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 16,n=32,30,24,22,22 | 1182.288 Milligrams | Standard Deviation 718.6186 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 12,n=34,32,24,22,24 | 1063.773 Milligrams | Standard Deviation 619.4002 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 24,n=30,25,19,18,17 | 1495.015 Milligrams | Standard Deviation 1055.9615 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 4,n=40,39,26,25,27 | 741.115 Milligrams | Standard Deviation 436.4205 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 28,n=24,23,15,17,15 | 1575.549 Milligrams | Standard Deviation 1170.7294 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 32,n=19,21,13,15,18 | 1716.863 Milligrams | Standard Deviation 1328.1426 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 2, n= 40,39,26,27,26 | 464.923 Milligrams | Standard Deviation 299.6445 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 48,n=10,16,9,8,11 | 1601.656 Milligrams | Standard Deviation 1362.9717 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 40,n=18,15,11,13,12 | 2023.342 Milligrams | Standard Deviation 1651.4092 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 36,n=19,17,14,13,14 | 1803.919 Milligrams | Standard Deviation 1536.5304 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 8,n=37, 37,26,23,26 | 987.730 Milligrams | Standard Deviation 559.4458 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 52,n=11,10,6,7,6 | 2418.213 Milligrams | Standard Deviation 2085.2345 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 44,n=17,13,10,12,13 | 1481.115 Milligrams | Standard Deviation 1381.3957 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 20,n=29,27,21,24,19 | 1475.786 Milligrams | Standard Deviation 734.7667 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 2, n= 40,39,26,27,26 | 424.577 Milligrams | Standard Deviation 270.2183 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 4,n=40,39,26,25,27 | 701.192 Milligrams | Standard Deviation 439.7251 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 8,n=37, 37,26,23,26 | 1014.731 Milligrams | Standard Deviation 592.3515 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 12,n=34,32,24,22,24 | 1208.167 Milligrams | Standard Deviation 650.6975 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 16,n=32,30,24,22,22 | 1348.750 Milligrams | Standard Deviation 689.2484 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 24,n=30,25,19,18,17 | 1626.342 Milligrams | Standard Deviation 813.8284 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 28,n=24,23,15,17,15 | 1797.533 Milligrams | Standard Deviation 933.3753 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 32,n=19,21,13,15,18 | 1859.346 Milligrams | Standard Deviation 858.5431 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 36,n=19,17,14,13,14 | 1705.214 Milligrams | Standard Deviation 802.8858 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 40,n=18,15,11,13,12 | 1842.500 Milligrams | Standard Deviation 904.4136 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 44,n=17,13,10,12,13 | 1980.733 Milligrams | Standard Deviation 1444.8664 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 48,n=10,16,9,8,11 | 1562.333 Milligrams | Standard Deviation 828.565 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 52,n=11,10,6,7,6 | 2556.222 Milligrams | Standard Deviation 1363.1832 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 20,n=29,27,21,24,19 | 1646.177 Milligrams | Standard Deviation 701.524 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 32,n=19,21,13,15,18 | 2531.417 Milligrams | Standard Deviation 1327.9125 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 16,n=32,30,24,22,22 | 1672.795 Milligrams | Standard Deviation 1261.7121 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 36,n=19,17,14,13,14 | 2617.817 Milligrams | Standard Deviation 1636.2516 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 12,n=34,32,24,22,24 | 1379.409 Milligrams | Standard Deviation 1255.4397 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 2, n= 40,39,26,27,26 | 432.815 Milligrams | Standard Deviation 315.6851 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 40,n=18,15,11,13,12 | 2960.144 Milligrams | Standard Deviation 1736.2249 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 8,n=37, 37,26,23,26 | 1161.391 Milligrams | Standard Deviation 1202.8504 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 44,n=17,13,10,12,13 | 2783.542 Milligrams | Standard Deviation 1776.0608 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 4,n=40,39,26,25,27 | 705.480 Milligrams | Standard Deviation 601.9706 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 52,n=11,10,6,7,6 | 3157.054 Milligrams | Standard Deviation 1988.061 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 24,n=30,25,19,18,17 | 1917.444 Milligrams | Standard Deviation 861.6887 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 48,n=10,16,9,8,11 | 2859.208 Milligrams | Standard Deviation 1882.7422 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 28,n=24,23,15,17,15 | 2141.294 Milligrams | Standard Deviation 1082.2754 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 24,n=30,25,19,18,17 | 2299.471 Milligrams | Standard Deviation 840.8758 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 52,n=11,10,6,7,6 | 3603.229 Milligrams | Standard Deviation 1477.6777 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 32,n=19,21,13,15,18 | 2404.500 Milligrams | Standard Deviation 808.8642 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 16,n=32,30,24,22,22 | 1729.977 Milligrams | Standard Deviation 701.3734 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 28,n=24,23,15,17,15 | 2387.800 Milligrams | Standard Deviation 741.1663 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 2, n= 40,39,26,27,26 | 430.846 Milligrams | Standard Deviation 241.354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 44,n=17,13,10,12,13 | 2954.760 Milligrams | Standard Deviation 1022.5491 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 36,n=19,17,14,13,14 | 2717.696 Milligrams | Standard Deviation 897.0689 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 12,n=34,32,24,22,24 | 1462.917 Milligrams | Standard Deviation 630.1717 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 4,n=40,39,26,25,27 | 751.407 Milligrams | Standard Deviation 431.3442 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 20,n=29,27,21,24,19 | 2041.632 Milligrams | Standard Deviation 771.3504 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 48,n=10,16,9,8,11 | 3167.898 Milligrams | Standard Deviation 1195.402 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 40,n=18,15,11,13,12 | 2963.865 Milligrams | Standard Deviation 909.0195 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Cumulative Prednisone Dose Over Time | Week 8,n=37, 37,26,23,26 | 1129.077 Milligrams | Standard Deviation 546.8037 |
Secondary
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.
Time frame: Baseline (Week 0), Weeks 12, 24, 36, 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 52, n=9,5,5,5,4 | 44.810 Scores on scale | Standard Deviation 6.4757 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 36, n=15,13,10,12,13 | 45.258 Scores on scale | Standard Deviation 5.2429 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Baseline, n=42,38,25,23,27 | 49.258 Scores on scale | Standard Deviation 11.7655 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 12, n=31,28,24,22,22 | 51.519 Scores on scale | Standard Deviation 10.5352 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 24, n=23,20,15,17,16 | 50.023 Scores on scale | Standard Deviation 11.4731 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 36, n=15,13,10,12,13 | 51.989 Scores on scale | Standard Deviation 10.7521 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 52, n=9,5,5,5,4 | 50.269 Scores on scale | Standard Deviation 10.8743 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 12, n=31,28,24,22,22 | 43.955 Scores on scale | Standard Deviation 4.6164 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 24, n=23,20,15,17,16 | 44.538 Scores on scale | Standard Deviation 5.6952 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 52, n=9,5,5,5,4 | 53.690 Scores on scale | Standard Deviation 7.9049 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 24, n=23,20,15,17,16 | 45.954 Scores on scale | Standard Deviation 5.4884 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 12, n=31,28,24,22,22 | 43.128 Scores on scale | Standard Deviation 11.4559 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 36, n=15,13,10,12,13 | 45.540 Scores on scale | Standard Deviation 4.833 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Baseline, n=42,38,25,23,27 | 43.271 Scores on scale | Standard Deviation 12.3169 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 36, n=15,13,10,12,13 | 47.069 Scores on scale | Standard Deviation 12.7103 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 12, n=31,28,24,22,22 | 45.264 Scores on scale | Standard Deviation 5.7982 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 24, n=23,20,15,17,16 | 45.677 Scores on scale | Standard Deviation 12.1192 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 52, n=9,5,5,5,4 | 45.008 Scores on scale | Standard Deviation 2.2373 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 24, n=23,20,15,17,16 | 45.097 Scores on scale | Standard Deviation 15.0552 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 12, n=31,28,24,22,22 | 46.393 Scores on scale | Standard Deviation 6.1792 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 36, n=15,13,10,12,13 | 46.005 Scores on scale | Standard Deviation 12.2496 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Baseline, n=42,38,25,23,27 | 42.919 Scores on scale | Standard Deviation 11.7298 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 24, n=23,20,15,17,16 | 44.877 Scores on scale | Standard Deviation 6.521 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 12, n=31,28,24,22,22 | 43.655 Scores on scale | Standard Deviation 11.0324 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 52, n=9,5,5,5,4 | 42.004 Scores on scale | Standard Deviation 5.5695 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 52, n=9,5,5,5,4 | 53.608 Scores on scale | Standard Deviation 7.7721 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 36, n=15,13,10,12,13 | 44.550 Scores on scale | Standard Deviation 6.7199 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 36, n=15,13,10,12,13 | 42.959 Scores on scale | Standard Deviation 4.8484 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 52, n=9,5,5,5,4 | 42.258 Scores on scale | Standard Deviation 4.1002 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Baseline, n=42,38,25,23,27 | 49.240 Scores on scale | Standard Deviation 9.2759 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 12, n=31,28,24,22,22 | 48.552 Scores on scale | Standard Deviation 10.4184 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 24, n=23,20,15,17,16 | 46.911 Scores on scale | Standard Deviation 9.2901 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 36, n=15,13,10,12,13 | 48.336 Scores on scale | Standard Deviation 10.0154 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 12, n=31,28,24,22,22 | 43.746 Scores on scale | Standard Deviation 5.3179 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 24, n=23,20,15,17,16 | 45.372 Scores on scale | Standard Deviation 6.4561 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 52, n=9,5,5,5,4 | 52.026 Scores on scale | Standard Deviation 6.4892 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 12, n=31,28,24,22,22 | 47.007 Scores on scale | Standard Deviation 12.8749 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 12, n=31,28,24,22,22 | 43.182 Scores on scale | Standard Deviation 4.6707 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Baseline, n=42,38,25,23,27 | 45.470 Scores on scale | Standard Deviation 12.8498 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 52, n=9,5,5,5,4 | 42.125 Scores on scale | Standard Deviation 1.902 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 24, n=23,20,15,17,16 | 45.526 Scores on scale | Standard Deviation 5.8924 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | MCS,Week 36, n=15,13,10,12,13 | 46.755 Scores on scale | Standard Deviation 4.8284 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 36, n=15,13,10,12,13 | 44.946 Scores on scale | Standard Deviation 10.1921 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 52, n=9,5,5,5,4 | 53.143 Scores on scale | Standard Deviation 12.8351 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | PCS,Week 24, n=23,20,15,17,16 | 44.280 Scores on scale | Standard Deviation 11.474 |
Secondary
Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'.
Time frame: Baseline (Week 0) and Weeks 12, 24, 36, 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 36, n=15,13,10,12,13 | 79.5 Scores on scale | Standard Deviation 9.55 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Baseline, n=42,38,25,23,27 | 67.0 Scores on scale | Standard Deviation 17.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 52, n=9,5,5,5,4 | 79.9 Scores on scale | Standard Deviation 9.74 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 12, n=31,28,24,22,22 | 74.3 Scores on scale | Standard Deviation 19.77 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 24, n=23,20,15,17,16 | 74.6 Scores on scale | Standard Deviation 16.26 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 36, n=15,13,10,12,13 | 73.9 Scores on scale | Standard Deviation 24.55 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 24, n=23,20,15,17,16 | 70.6 Scores on scale | Standard Deviation 24.05 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 12, n=31,28,24,22,22 | 64.2 Scores on scale | Standard Deviation 22.89 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 52, n=9,5,5,5,4 | 80.6 Scores on scale | Standard Deviation 16.5 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Baseline, n=42,38,25,23,27 | 65.6 Scores on scale | Standard Deviation 21.43 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 24, n=23,20,15,17,16 | 65.1 Scores on scale | Standard Deviation 23.11 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Baseline, n=42,38,25,23,27 | 57.0 Scores on scale | Standard Deviation 17.61 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 12, n=31,28,24,22,22 | 68.4 Scores on scale | Standard Deviation 19.39 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 36, n=15,13,10,12,13 | 66.9 Scores on scale | Standard Deviation 20.72 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 52, n=9,5,5,5,4 | 78.4 Scores on scale | Standard Deviation 14.77 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 52, n=9,5,5,5,4 | 60.2 Scores on scale | Standard Deviation 26.33 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Baseline, n=42,38,25,23,27 | 62.1 Scores on scale | Standard Deviation 23.81 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 36, n=15,13,10,12,13 | 68.3 Scores on scale | Standard Deviation 18.66 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 24, n=23,20,15,17,16 | 64.9 Scores on scale | Standard Deviation 19.03 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 12, n=31,28,24,22,22 | 63.3 Scores on scale | Standard Deviation 22.61 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 24, n=23,20,15,17,16 | 61.5 Scores on scale | Standard Deviation 19.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 36, n=15,13,10,12,13 | 61.6 Scores on scale | Standard Deviation 21.29 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Baseline, n=42,38,25,23,27 | 65.1 Scores on scale | Standard Deviation 16 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 52, n=9,5,5,5,4 | 70.0 Scores on scale | Standard Deviation 27.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time | Week 12, n=31,28,24,22,22 | 65.5 Scores on scale | Standard Deviation 21.33 |
Secondary
Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).
Time frame: Baseline (Week 0) and Weeks 12, 24, 36, 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 36, n=15,13,10,12,13 | 0.8011 Scores on scale | Standard Deviation 0.13468 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Baseline, n=42,38,25,23,27 | 0.7918 Scores on scale | Standard Deviation 0.20589 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 52, n=9,5,5,5,4 | 0.8210 Scores on scale | Standard Deviation 0.13502 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 12, n=31,28,24,22,22 | 0.7866 Scores on scale | Standard Deviation 0.22042 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 24, n=23,20,15,17,16 | 0.7485 Scores on scale | Standard Deviation 0.2031 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 36, n=15,13,10,12,13 | 0.7454 Scores on scale | Standard Deviation 0.22373 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 24, n=23,20,15,17,16 | 0.7217 Scores on scale | Standard Deviation 0.21397 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 12, n=31,28,24,22,22 | 0.7024 Scores on scale | Standard Deviation 0.22087 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 52, n=9,5,5,5,4 | 0.7628 Scores on scale | Standard Deviation 0.15352 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Baseline, n=42,38,25,23,27 | 0.6681 Scores on scale | Standard Deviation 0.31299 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 24, n=23,20,15,17,16 | 0.7135 Scores on scale | Standard Deviation 0.24006 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Baseline, n=42,38,25,23,27 | 0.6912 Scores on scale | Standard Deviation 0.19348 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 12, n=31,28,24,22,22 | 0.7452 Scores on scale | Standard Deviation 0.17942 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 36, n=15,13,10,12,13 | 0.7774 Scores on scale | Standard Deviation 0.11809 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 52, n=9,5,5,5,4 | 0.8092 Scores on scale | Standard Deviation 0.04275 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 52, n=9,5,5,5,4 | 0.7864 Scores on scale | Standard Deviation 0.05892 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Baseline, n=42,38,25,23,27 | 0.7429 Scores on scale | Standard Deviation 0.22387 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 36, n=15,13,10,12,13 | 0.6950 Scores on scale | Standard Deviation 0.15242 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 24, n=23,20,15,17,16 | 0.7323 Scores on scale | Standard Deviation 0.10346 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 12, n=31,28,24,22,22 | 0.7228 Scores on scale | Standard Deviation 0.16993 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 24, n=23,20,15,17,16 | 0.7301 Scores on scale | Standard Deviation 0.11498 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 36, n=15,13,10,12,13 | 0.7506 Scores on scale | Standard Deviation 0.17536 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Baseline, n=42,38,25,23,27 | 0.7554 Scores on scale | Standard Deviation 0.1661 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 52, n=9,5,5,5,4 | 0.8068 Scores on scale | Standard Deviation 0.0605 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time | Week 12, n=31,28,24,22,22 | 0.7069 Scores on scale | Standard Deviation 0.22289 |
Secondary
Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.
Time frame: Baseline (Week 0), Weeks 12, 24, 36, 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 36, n=15,13,10,12,13 | 41.4 Scores on scale | Standard Deviation 9.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Baseline, n=42,38,25,23,27 | 38.7 Scores on scale | Standard Deviation 10.72 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 52, n=9,5,5,5,4 | 42.1 Scores on scale | Standard Deviation 6.72 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 12, n=31,28,24,22,22 | 40.2 Scores on scale | Standard Deviation 8.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 24, n=23,20,15,17,16 | 38.1 Scores on scale | Standard Deviation 10.48 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 36, n=15,13,10,12,13 | 38.4 Scores on scale | Standard Deviation 9.95 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 24, n=23,20,15,17,16 | 36.5 Scores on scale | Standard Deviation 13.22 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 12, n=31,28,24,22,22 | 32.7 Scores on scale | Standard Deviation 11.25 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 52, n=9,5,5,5,4 | 43.0 Scores on scale | Standard Deviation 6.48 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Baseline, n=42,38,25,23,27 | 34.2 Scores on scale | Standard Deviation 12.25 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 24, n=23,20,15,17,16 | 31.2 Scores on scale | Standard Deviation 13.09 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Baseline, n=42,38,25,23,27 | 31.1 Scores on scale | Standard Deviation 9.89 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 12, n=31,28,24,22,22 | 34.3 Scores on scale | Standard Deviation 11.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 36, n=15,13,10,12,13 | 36.9 Scores on scale | Standard Deviation 10.88 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 52, n=9,5,5,5,4 | 40.4 Scores on scale | Standard Deviation 5.22 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 52, n=9,5,5,5,4 | 44.0 Scores on scale | Standard Deviation 5.48 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Baseline, n=42,38,25,23,27 | 38.0 Scores on scale | Standard Deviation 8.37 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 36, n=15,13,10,12,13 | 40.9 Scores on scale | Standard Deviation 6.49 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 24, n=23,20,15,17,16 | 36.2 Scores on scale | Standard Deviation 6.15 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 12, n=31,28,24,22,22 | 38.5 Scores on scale | Standard Deviation 9.82 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 24, n=23,20,15,17,16 | 36.0 Scores on scale | Standard Deviation 9.18 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 36, n=15,13,10,12,13 | 37.5 Scores on scale | Standard Deviation 10.02 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Baseline, n=42,38,25,23,27 | 34.1 Scores on scale | Standard Deviation 13.32 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 52, n=9,5,5,5,4 | 41.0 Scores on scale | Standard Deviation 12.25 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time | Week 12, n=31,28,24,22,22 | 35.5 Scores on scale | Standard Deviation 13.34 |
Secondary
Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
Time frame: Baseline (Week 0) and Weeks 12, 24, 36 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 36, n=6,5,4,4,7 | 0.5208 Scores on scale | Standard Deviation 0.70007 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Baseline, n=19,14,13,9,12 | 0.6776 Scores on scale | Standard Deviation 0.65658 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 52, n=5,2,3,1,2 | 0.3000 Scores on scale | Standard Deviation 0.41079 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 12, n=12,8,12,9,9 | 0.3229 Scores on scale | Standard Deviation 0.41785 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 24, n=10, 7,7,7,9 | 0.5875 Scores on scale | Standard Deviation 0.5894 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 36, n=6,5,4,4,7 | 0.8250 Scores on scale | Standard Deviation 0.80816 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 24, n=10, 7,7,7,9 | 0.8750 Scores on scale | Standard Deviation 0.78395 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 12, n=12,8,12,9,9 | 1.0938 Scores on scale | Standard Deviation 0.91063 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 52, n=5,2,3,1,2 | 0.3125 Scores on scale | Standard Deviation 0.44194 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Baseline, n=19,14,13,9,12 | 1.1250 Scores on scale | Standard Deviation 0.75479 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 24, n=10, 7,7,7,9 | 0.9821 Scores on scale | Standard Deviation 0.92823 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Baseline, n=19,14,13,9,12 | 0.9615 Scores on scale | Standard Deviation 0.84376 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 12, n=12,8,12,9,9 | 0.7292 Scores on scale | Standard Deviation 0.87392 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 36, n=6,5,4,4,7 | 0.6250 Scores on scale | Standard Deviation 0.51031 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 52, n=5,2,3,1,2 | 0.1667 Scores on scale | Standard Deviation 0.14434 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 52, n=5,2,3,1,2 | 0.0000 Scores on scale | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Baseline, n=19,14,13,9,12 | 0.8889 Scores on scale | Standard Deviation 0.80875 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 36, n=6,5,4,4,7 | 0.5625 Scores on scale | Standard Deviation 0.58184 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 24, n=10, 7,7,7,9 | 0.9107 Scores on scale | Standard Deviation 0.83452 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 12, n=12,8,12,9,9 | 0.5694 Scores on scale | Standard Deviation 0.54526 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 24, n=10, 7,7,7,9 | 0.9583 Scores on scale | Standard Deviation 0.70986 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 36, n=6,5,4,4,7 | 1.0000 Scores on scale | Standard Deviation 0.91287 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Baseline, n=19,14,13,9,12 | 0.8646 Scores on scale | Standard Deviation 0.62034 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 52, n=5,2,3,1,2 | 0.1875 Scores on scale | Standard Deviation 0.26517 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time | Week 12, n=12,8,12,9,9 | 0.9306 Scores on scale | Standard Deviation 0.66764 |
Secondary
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Data for NRS scores over time for part A is reported.
Time frame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 52, n=9,5,5,5,4 | 1.3 Scores on scale | Standard Deviation 1.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 8, n=34,30,24,21,23 | 1.8 Scores on scale | Standard Deviation 2.42 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 36, n=15,13,10,12,13 | 1.6 Scores on scale | Standard Deviation 1.88 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 2, n=38,38,25,21,27 | 1.3 Scores on scale | Standard Deviation 1.55 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Baseline, n=42,38,25,23,27 | 1.8 Scores on scale | Standard Deviation 2.31 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 16, n=27,25,22,19,19 | 1.4 Scores on scale | Standard Deviation 2.22 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 12, n=31,28,24,22,22 | 1.7 Scores on scale | Standard Deviation 2.3 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 28, n=18,17,11,13,14 | 2.6 Scores on scale | Standard Deviation 2.38 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 44, n=11,11,6,8,8 | 2.1 Scores on scale | Standard Deviation 2.74 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 4, n=36,37,24,22,27 | 1.7 Scores on scale | Standard Deviation 2.16 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 32, n=19,14,9,12,12 | 2.1 Scores on scale | Standard Deviation 2.57 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 40, n=15,11,9,10,10 | 2.0 Scores on scale | Standard Deviation 2.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 24, n=23,20,15,17,16 | 2.4 Scores on scale | Standard Deviation 2.82 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 20, n=26,23,19,18,15 | 1.7 Scores on scale | Standard Deviation 2.27 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 48, n=9,8,5,7,5 | 1.9 Scores on scale | Standard Deviation 2.42 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 2, n=38,38,25,21,27 | 2.8 Scores on scale | Standard Deviation 3.08 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 32, n=19,14,9,12,12 | 1.9 Scores on scale | Standard Deviation 2.67 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 52, n=9,5,5,5,4 | 0.8 Scores on scale | Standard Deviation 0.84 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 36, n=15,13,10,12,13 | 2.0 Scores on scale | Standard Deviation 2.55 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 40, n=15,11,9,10,10 | 2.0 Scores on scale | Standard Deviation 2.57 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 4, n=36,37,24,22,27 | 3.1 Scores on scale | Standard Deviation 3.13 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 8, n=34,30,24,21,23 | 2.9 Scores on scale | Standard Deviation 2.73 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 12, n=31,28,24,22,22 | 3.6 Scores on scale | Standard Deviation 3.05 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 48, n=9,8,5,7,5 | 0.8 Scores on scale | Standard Deviation 1.04 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 16, n=27,25,22,19,19 | 3.3 Scores on scale | Standard Deviation 2.84 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 20, n=26,23,19,18,15 | 2.9 Scores on scale | Standard Deviation 2.7 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 24, n=23,20,15,17,16 | 2.5 Scores on scale | Standard Deviation 2.42 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 44, n=11,11,6,8,8 | 1.9 Scores on scale | Standard Deviation 2.47 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 28, n=18,17,11,13,14 | 2.8 Scores on scale | Standard Deviation 3.03 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Baseline, n=42,38,25,23,27 | 2.5 Scores on scale | Standard Deviation 2.97 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Baseline, n=42,38,25,23,27 | 3.1 Scores on scale | Standard Deviation 2.27 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 4, n=36,37,24,22,27 | 3.3 Scores on scale | Standard Deviation 2.2 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 28, n=18,17,11,13,14 | 3.6 Scores on scale | Standard Deviation 2.87 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 20, n=26,23,19,18,15 | 3.6 Scores on scale | Standard Deviation 2.63 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 36, n=15,13,10,12,13 | 2.9 Scores on scale | Standard Deviation 2.02 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 44, n=11,11,6,8,8 | 2.2 Scores on scale | Standard Deviation 1.72 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 40, n=15,11,9,10,10 | 3.1 Scores on scale | Standard Deviation 2.09 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 32, n=19,14,9,12,12 | 2.9 Scores on scale | Standard Deviation 1.9 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 12, n=31,28,24,22,22 | 3.3 Scores on scale | Standard Deviation 2.42 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 52, n=9,5,5,5,4 | 2.8 Scores on scale | Standard Deviation 2.28 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 24, n=23,20,15,17,16 | 3.3 Scores on scale | Standard Deviation 2.94 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 48, n=9,8,5,7,5 | 2.6 Scores on scale | Standard Deviation 0.89 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 2, n=38,38,25,21,27 | 2.8 Scores on scale | Standard Deviation 1.96 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 16, n=27,25,22,19,19 | 3.0 Scores on scale | Standard Deviation 2.6 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 8, n=34,30,24,21,23 | 3.0 Scores on scale | Standard Deviation 2.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 2, n=38,38,25,21,27 | 2.6 Scores on scale | Standard Deviation 2.13 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Baseline, n=42,38,25,23,27 | 2.6 Scores on scale | Standard Deviation 2.09 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 52, n=9,5,5,5,4 | 2.2 Scores on scale | Standard Deviation 0.84 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 4, n=36,37,24,22,27 | 2.4 Scores on scale | Standard Deviation 2.28 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 8, n=34,30,24,21,23 | 2.1 Scores on scale | Standard Deviation 1.96 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 12, n=31,28,24,22,22 | 2.3 Scores on scale | Standard Deviation 2.5 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 16, n=27,25,22,19,19 | 2.4 Scores on scale | Standard Deviation 2.06 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 20, n=26,23,19,18,15 | 1.4 Scores on scale | Standard Deviation 1.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 24, n=23,20,15,17,16 | 2.4 Scores on scale | Standard Deviation 1.84 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 28, n=18,17,11,13,14 | 2.3 Scores on scale | Standard Deviation 2.14 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 32, n=19,14,9,12,12 | 2.6 Scores on scale | Standard Deviation 2.15 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 36, n=15,13,10,12,13 | 2.3 Scores on scale | Standard Deviation 2.42 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 40, n=15,11,9,10,10 | 1.9 Scores on scale | Standard Deviation 1.91 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 44, n=11,11,6,8,8 | 1.3 Scores on scale | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 48, n=9,8,5,7,5 | 1.6 Scores on scale | Standard Deviation 1.27 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 40, n=15,11,9,10,10 | 2.6 Scores on scale | Standard Deviation 2.07 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 28, n=18,17,11,13,14 | 2.9 Scores on scale | Standard Deviation 2.4 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 24, n=23,20,15,17,16 | 3.5 Scores on scale | Standard Deviation 2.22 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 20, n=26,23,19,18,15 | 2.7 Scores on scale | Standard Deviation 2.02 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Baseline, n=42,38,25,23,27 | 2.6 Scores on scale | Standard Deviation 2.39 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 44, n=11,11,6,8,8 | 3.0 Scores on scale | Standard Deviation 2.39 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 16, n=27,25,22,19,19 | 2.7 Scores on scale | Standard Deviation 2.16 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 12, n=31,28,24,22,22 | 2.0 Scores on scale | Standard Deviation 2.08 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 8, n=34,30,24,21,23 | 3.3 Scores on scale | Standard Deviation 2.82 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 52, n=9,5,5,5,4 | 1.0 Scores on scale | Standard Deviation 0.82 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 48, n=9,8,5,7,5 | 4.0 Scores on scale | Standard Deviation 3.74 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 4, n=36,37,24,22,27 | 1.8 Scores on scale | Standard Deviation 1.72 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 36, n=15,13,10,12,13 | 1.9 Scores on scale | Standard Deviation 1.93 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 32, n=19,14,9,12,12 | 3.1 Scores on scale | Standard Deviation 2.35 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time | Week 2, n=38,38,25,21,27 | 2.6 Scores on scale | Standard Deviation 2.63 |
Secondary
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor).
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 32, n=19,14,9,12,12 | 2.01 Scores on scale | Standard Deviation 1.781 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 28, n=18,17,11,13,14 | 2.44 Scores on scale | Standard Deviation 2.094 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 24, n=23,20,15,17,16 | 2.63 Scores on scale | Standard Deviation 2.14 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Baseline, n=42,39,25,26,27 | 2.96 Scores on scale | Standard Deviation 2.148 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 48, n=9,8,5,7,5 | 1.81 Scores on scale | Standard Deviation 1.934 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 4, n=36,37,24,22,27 | 2.43 Scores on scale | Standard Deviation 2.138 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 44, n=11,11,6,8,8 | 2.28 Scores on scale | Standard Deviation 2.872 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 8, n=34,30,24,21,23 | 1.97 Scores on scale | Standard Deviation 2.076 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 52, n=9,5,5,5,4 | 1.10 Scores on scale | Standard Deviation 0.857 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 40, n=15,11,9,10,10 | 2.05 Scores on scale | Standard Deviation 1.809 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 12, n=31,28,24,22,22 | 1.97 Scores on scale | Standard Deviation 1.567 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 2, n=38,38,25,21,27 | 2.59 Scores on scale | Standard Deviation 1.923 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 36, n=15,13,10,12,13 | 1.46 Scores on scale | Standard Deviation 1.253 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 16, n=27,25,22,19,19 | 1.95 Scores on scale | Standard Deviation 2.237 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 20, n=26,23,19,18,15 | 2.60 Scores on scale | Standard Deviation 2.089 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 16, n=27,25,22,19,19 | 3.82 Scores on scale | Standard Deviation 2.615 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 20, n=26,23,19,18,15 | 3.20 Scores on scale | Standard Deviation 2.663 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Baseline, n=42,39,25,26,27 | 3.72 Scores on scale | Standard Deviation 2.649 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 28, n=18,17,11,13,14 | 3.09 Scores on scale | Standard Deviation 2.915 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 8, n=34,30,24,21,23 | 3.87 Scores on scale | Standard Deviation 2.322 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 36, n=15,13,10,12,13 | 2.66 Scores on scale | Standard Deviation 2.982 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 24, n=23,20,15,17,16 | 2.33 Scores on scale | Standard Deviation 1.975 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 40, n=15,11,9,10,10 | 2.35 Scores on scale | Standard Deviation 2.495 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 48, n=9,8,5,7,5 | 1.03 Scores on scale | Standard Deviation 1.253 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 2, n=38,38,25,21,27 | 3.51 Scores on scale | Standard Deviation 2.389 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 32, n=19,14,9,12,12 | 2.22 Scores on scale | Standard Deviation 2.564 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 4, n=36,37,24,22,27 | 3.75 Scores on scale | Standard Deviation 2.77 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 52, n=9,5,5,5,4 | 0.46 Scores on scale | Standard Deviation 0.358 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 44, n=11,11,6,8,8 | 2.19 Scores on scale | Standard Deviation 2.429 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 12, n=31,28,24,22,22 | 3.80 Scores on scale | Standard Deviation 2.557 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 24, n=23,20,15,17,16 | 3.83 Scores on scale | Standard Deviation 2.447 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Baseline, n=42,39,25,26,27 | 4.24 Scores on scale | Standard Deviation 2.049 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 2, n=38,38,25,21,27 | 3.73 Scores on scale | Standard Deviation 1.911 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 4, n=36,37,24,22,27 | 3.81 Scores on scale | Standard Deviation 1.737 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 8, n=34,30,24,21,23 | 3.44 Scores on scale | Standard Deviation 1.763 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 12, n=31,28,24,22,22 | 3.95 Scores on scale | Standard Deviation 2.2 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 16, n=27,25,22,19,19 | 3.39 Scores on scale | Standard Deviation 2.523 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 20, n=26,23,19,18,15 | 4.17 Scores on scale | Standard Deviation 2.334 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 28, n=18,17,11,13,14 | 4.18 Scores on scale | Standard Deviation 2.169 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 32, n=19,14,9,12,12 | 3.02 Scores on scale | Standard Deviation 1.199 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 36, n=15,13,10,12,13 | 2.79 Scores on scale | Standard Deviation 2.013 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 40, n=15,11,9,10,10 | 3.20 Scores on scale | Standard Deviation 2.329 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 44, n=11,11,6,8,8 | 2.17 Scores on scale | Standard Deviation 1.824 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 48, n=9,8,5,7,5 | 2.30 Scores on scale | Standard Deviation 1.515 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 52, n=9,5,5,5,4 | 2.76 Scores on scale | Standard Deviation 2.668 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 36, n=15,13,10,12,13 | 2.68 Scores on scale | Standard Deviation 2.49 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 4, n=36,37,24,22,27 | 3.01 Scores on scale | Standard Deviation 1.997 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 32, n=19,14,9,12,12 | 2.43 Scores on scale | Standard Deviation 2.385 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 44, n=11,11,6,8,8 | 2.18 Scores on scale | Standard Deviation 1.835 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 12, n=31,28,24,22,22 | 3.20 Scores on scale | Standard Deviation 2.34 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 8, n=34,30,24,21,23 | 2.85 Scores on scale | Standard Deviation 1.769 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 2, n=38,38,25,21,27 | 3.45 Scores on scale | Standard Deviation 2.247 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 52, n=9,5,5,5,4 | 2.44 Scores on scale | Standard Deviation 1.716 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 24, n=23,20,15,17,16 | 2.85 Scores on scale | Standard Deviation 2.256 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Baseline, n=42,39,25,26,27 | 3.60 Scores on scale | Standard Deviation 2.133 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 40, n=15,11,9,10,10 | 2.24 Scores on scale | Standard Deviation 1.883 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 20, n=26,23,19,18,15 | 2.45 Scores on scale | Standard Deviation 1.697 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 48, n=9,8,5,7,5 | 1.86 Scores on scale | Standard Deviation 1.586 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 28, n=18,17,11,13,14 | 2.68 Scores on scale | Standard Deviation 2.106 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 16, n=27,25,22,19,19 | 2.86 Scores on scale | Standard Deviation 1.809 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 28, n=18,17,11,13,14 | 2.74 Scores on scale | Standard Deviation 1.791 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 48, n=9,8,5,7,5 | 4.48 Scores on scale | Standard Deviation 3.545 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 32, n=19,14,9,12,12 | 2.88 Scores on scale | Standard Deviation 2.541 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 12, n=31,28,24,22,22 | 2.75 Scores on scale | Standard Deviation 2.056 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Baseline, n=42,39,25,26,27 | 3.64 Scores on scale | Standard Deviation 2.732 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 36, n=15,13,10,12,13 | 2.62 Scores on scale | Standard Deviation 1.99 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 8, n=34,30,24,21,23 | 2.90 Scores on scale | Standard Deviation 2.23 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 40, n=15,11,9,10,10 | 3.00 Scores on scale | Standard Deviation 2.658 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 4, n=36,37,24,22,27 | 2.62 Scores on scale | Standard Deviation 1.762 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 52, n=9,5,5,5,4 | 2.13 Scores on scale | Standard Deviation 2.651 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 44, n=11,11,6,8,8 | 3.49 Scores on scale | Standard Deviation 2.322 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 2, n=38,38,25,21,27 | 3.52 Scores on scale | Standard Deviation 2.177 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 24, n=23,20,15,17,16 | 3.34 Scores on scale | Standard Deviation 1.791 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 20, n=26,23,19,18,15 | 2.90 Scores on scale | Standard Deviation 1.869 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time | Week 16, n=27,25,22,19,19 | 2.76 Scores on scale | Standard Deviation 1.777 |
Secondary
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (none) to 10 (extremely active).
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 32, n=19,14,8,11,12 | 0.83 Scores on scale | Standard Deviation 1.32 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 28, n=17,17,11,12,13 | 0.76 Scores on scale | Standard Deviation 1.068 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 24, n=20,20,15,15,15 | 0.82 Scores on scale | Standard Deviation 1.089 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Baseline, n=42,39,25,26,27 | 2.33 Scores on scale | Standard Deviation 2.101 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 48, n=7,7,5,6,5 | 0.27 Scores on scale | Standard Deviation 0.446 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 4, n=33,32,23,21,25 | 0.81 Scores on scale | Standard Deviation 1.191 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 44, n=10,9,6,8,7 | 0.31 Scores on scale | Standard Deviation 0.228 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 8, n=33,28,23,20,21 | 1.09 Scores on scale | Standard Deviation 1.508 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 52, n=9,5,5,4,4 | 0.31 Scores on scale | Standard Deviation 0.434 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 40, n=13,9,8,9,10 | 0.38 Scores on scale | Standard Deviation 0.395 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 12, n=29,25,23,18,21 | 1.08 Scores on scale | Standard Deviation 1.486 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 2, n=36,35,25,20,26 | 1.09 Scores on scale | Standard Deviation 1.373 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 36, n=13,11,10,11,13 | 0.48 Scores on scale | Standard Deviation 0.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 16, n=26,23,21,16,19 | 0.74 Scores on scale | Standard Deviation 0.895 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 20, n=25,23,18,17,15 | 0.71 Scores on scale | Standard Deviation 1.189 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 16, n=26,23,21,16,19 | 1.54 Scores on scale | Standard Deviation 1.793 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 20, n=25,23,18,17,15 | 1.42 Scores on scale | Standard Deviation 1.808 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Baseline, n=42,39,25,26,27 | 2.95 Scores on scale | Standard Deviation 2.208 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 28, n=17,17,11,12,13 | 1.43 Scores on scale | Standard Deviation 1.986 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 8, n=33,28,23,20,21 | 1.30 Scores on scale | Standard Deviation 1.723 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 36, n=13,11,10,11,13 | 1.12 Scores on scale | Standard Deviation 1.589 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 24, n=20,20,15,15,15 | 0.68 Scores on scale | Standard Deviation 0.869 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 40, n=13,9,8,9,10 | 0.77 Scores on scale | Standard Deviation 1.417 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 48, n=7,7,5,6,5 | 0.31 Scores on scale | Standard Deviation 0.54 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 2, n=36,35,25,20,26 | 1.52 Scores on scale | Standard Deviation 1.822 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 32, n=19,14,8,11,12 | 0.67 Scores on scale | Standard Deviation 0.841 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 4, n=33,32,23,21,25 | 1.44 Scores on scale | Standard Deviation 1.904 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 52, n=9,5,5,4,4 | 0.10 Scores on scale | Standard Deviation 0.141 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 44, n=10,9,6,8,7 | 1.07 Scores on scale | Standard Deviation 1.574 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 12, n=29,25,23,18,21 | 1.81 Scores on scale | Standard Deviation 2.183 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 24, n=20,20,15,15,15 | 1.50 Scores on scale | Standard Deviation 1.69 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Baseline, n=42,39,25,26,27 | 2.94 Scores on scale | Standard Deviation 2.374 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 2, n=36,35,25,20,26 | 1.83 Scores on scale | Standard Deviation 1.558 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 4, n=33,32,23,21,25 | 1.55 Scores on scale | Standard Deviation 1.236 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 8, n=33,28,23,20,21 | 1.35 Scores on scale | Standard Deviation 1.229 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 12, n=29,25,23,18,21 | 1.64 Scores on scale | Standard Deviation 1.908 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 16, n=26,23,21,16,19 | 1.87 Scores on scale | Standard Deviation 2.078 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 20, n=25,23,18,17,15 | 1.16 Scores on scale | Standard Deviation 1.628 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 28, n=17,17,11,12,13 | 1.18 Scores on scale | Standard Deviation 2.116 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 32, n=19,14,8,11,12 | 1.40 Scores on scale | Standard Deviation 1.516 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 36, n=13,11,10,11,13 | 0.61 Scores on scale | Standard Deviation 0.792 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 40, n=13,9,8,9,10 | 0.36 Scores on scale | Standard Deviation 0.283 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 44, n=10,9,6,8,7 | 0.43 Scores on scale | Standard Deviation 0.547 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 48, n=7,7,5,6,5 | 0.30 Scores on scale | Standard Deviation 0.316 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 52, n=9,5,5,4,4 | 0.32 Scores on scale | Standard Deviation 0.311 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 36, n=13,11,10,11,13 | 0.56 Scores on scale | Standard Deviation 0.408 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 4, n=33,32,23,21,25 | 0.92 Scores on scale | Standard Deviation 1.125 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 32, n=19,14,8,11,12 | 1.26 Scores on scale | Standard Deviation 1.546 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 44, n=10,9,6,8,7 | 0.58 Scores on scale | Standard Deviation 0.74 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 12, n=29,25,23,18,21 | 1.28 Scores on scale | Standard Deviation 1.629 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 8, n=33,28,23,20,21 | 0.79 Scores on scale | Standard Deviation 0.798 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 2, n=36,35,25,20,26 | 1.85 Scores on scale | Standard Deviation 1.879 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 52, n=9,5,5,4,4 | 1.35 Scores on scale | Standard Deviation 0.947 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 24, n=20,20,15,15,15 | 1.48 Scores on scale | Standard Deviation 2.003 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Baseline, n=42,39,25,26,27 | 3.05 Scores on scale | Standard Deviation 2.501 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 40, n=13,9,8,9,10 | 0.52 Scores on scale | Standard Deviation 0.531 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 20, n=25,23,18,17,15 | 0.83 Scores on scale | Standard Deviation 0.882 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 48, n=7,7,5,6,5 | 0.78 Scores on scale | Standard Deviation 1.482 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 28, n=17,17,11,12,13 | 0.88 Scores on scale | Standard Deviation 0.586 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 16, n=26,23,21,16,19 | 1.39 Scores on scale | Standard Deviation 1.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 28, n=17,17,11,12,13 | 0.85 Scores on scale | Standard Deviation 1.44 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 48, n=7,7,5,6,5 | 1.60 Scores on scale | Standard Deviation 2.164 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 32, n=19,14,8,11,12 | 0.89 Scores on scale | Standard Deviation 1.672 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 12, n=29,25,23,18,21 | 1.47 Scores on scale | Standard Deviation 2.151 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Baseline, n=42,39,25,26,27 | 3.25 Scores on scale | Standard Deviation 2.823 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 36, n=13,11,10,11,13 | 0.75 Scores on scale | Standard Deviation 0.906 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 8, n=33,28,23,20,21 | 1.14 Scores on scale | Standard Deviation 1.226 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 40, n=13,9,8,9,10 | 0.57 Scores on scale | Standard Deviation 0.566 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 4, n=33,32,23,21,25 | 1.02 Scores on scale | Standard Deviation 1.09 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 52, n=9,5,5,4,4 | 1.80 Scores on scale | Standard Deviation 3.082 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 44, n=10,9,6,8,7 | 0.87 Scores on scale | Standard Deviation 1.404 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 2, n=36,35,25,20,26 | 1.76 Scores on scale | Standard Deviation 2.094 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 24, n=20,20,15,15,15 | 1.37 Scores on scale | Standard Deviation 1.551 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 20, n=25,23,18,17,15 | 1.27 Scores on scale | Standard Deviation 1.622 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time | Week 16, n=26,23,21,16,19 | 0.67 Scores on scale | Standard Deviation 0.779 |
Secondary
Part A: Mean Serum Anti-sirukumab Antibodies
Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points.
Time frame: Baseline (Week 0) and up to 52 weeks
Population: Safety Population. Data was not collected due to early termination of the study
Secondary
Part A: Mean Serum Concentrations of Sirukumab
Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points.
Time frame: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52
Population: Safety Population. Data was not collected due to early termination of the study
Secondary
Part A: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 52, n=9,5,5,5,4 | 1 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 32, n=19,15,10,12,13 | 5 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 24, n=23,21,16,17,16 | 6 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 4, n=37,37,25,23,27 | 3 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 28, n=19,18,12,14,14 | 5 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 48, n=9,8,5,8,5 | 1 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 8, n=34,32,24,23,23 | 2 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 44, n=11,11,6,8,9 | 1 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 12, n=32,29,24,22,22 | 4 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 2, n=38, 39,26,25,27 | 1 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 40, n=15,11,9,10,10 | 2 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 16, n=28,26,22,19,19 | 4 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 36, n=15,13,10,12,13 | 3 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 20, n=26,23,19,18,16 | 4 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 32, n=19,15,10,12,13 | 8 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 40, n=15,11,9,10,10 | 7 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 16, n=28,26,22,19,19 | 9 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 24, n=23,21,16,17,16 | 9 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 12, n=32,29,24,22,22 | 9 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 28, n=19,18,12,14,14 | 8 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 52, n=9,5,5,5,4 | 2 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 4, n=37,37,25,23,27 | 4 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 48, n=9,8,5,8,5 | 4 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 20, n=26,23,19,18,16 | 9 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 44, n=11,11,6,8,9 | 8 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 36, n=15,13,10,12,13 | 8 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 8, n=34,32,24,23,23 | 6 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 2, n=38, 39,26,25,27 | 2 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 4, n=37,37,25,23,27 | 3 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 2, n=38, 39,26,25,27 | 2 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 8, n=34,32,24,23,23 | 3 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 12, n=32,29,24,22,22 | 4 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 16, n=28,26,22,19,19 | 5 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 20, n=26,23,19,18,16 | 6 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 24, n=23,21,16,17,16 | 8 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 28, n=19,18,12,14,14 | 8 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 32, n=19,15,10,12,13 | 5 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 36, n=15,13,10,12,13 | 5 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 40, n=15,11,9,10,10 | 5 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 44, n=11,11,6,8,9 | 3 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 48, n=9,8,5,8,5 | 1 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 52, n=9,5,5,5,4 | 1 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 32, n=19,15,10,12,13 | 10 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 12, n=32,29,24,22,22 | 4 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 44, n=11,11,6,8,9 | 6 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 16, n=28,26,22,19,19 | 9 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 4, n=37,37,25,23,27 | 0 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 20, n=26,23,19,18,16 | 10 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 52, n=9,5,5,5,4 | 7 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 2, n=38, 39,26,25,27 | 0 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 24, n=23,21,16,17,16 | 11 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 48, n=9,8,5,8,5 | 7 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 28, n=19,18,12,14,14 | 11 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 40, n=15,11,9,10,10 | 8 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 36, n=15,13,10,12,13 | 10 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 8, n=34,32,24,23,23 | 1 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 16, n=28,26,22,19,19 | 4 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 32, n=19,15,10,12,13 | 6 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 12, n=32,29,24,22,22 | 4 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 2, n=38, 39,26,25,27 | 2 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 36, n=15,13,10,12,13 | 6 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 8, n=34,32,24,23,23 | 5 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 40, n=15,11,9,10,10 | 5 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 4, n=37,37,25,23,27 | 2 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 52, n=9,5,5,5,4 | 4 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 44, n=11,11,6,8,9 | 7 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 24, n=23,21,16,17,16 | 5 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 28, n=19,18,12,14,14 | 5 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 20, n=26,23,19,18,16 | 3 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Disease Flares Over Time | Week 48, n=9,8,5,8,5 | 3 Disease flares |
Secondary
Part A: Number of Hospitalizations for Disease Flare Over Time
Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 2, n=38, 39,26,25,27 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 32, n=19,15,10,12,13 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 24, n=23,21,16,17,16 | 2 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 28, n=19,18,12,14,14 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 48, n=9,8,5,8,5 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 8, n=34,32,24,23,23 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 44, n=11,11,6,8,9 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 12, n=32,29,24,22,22 | 2 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 52, n=9,5,5,5,4 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 40, n=15,11,9,10,10 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 16, n=28,26,22,19,19 | 2 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 4, n=37,37,25,23,27 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 36, n=15,13,10,12,13 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 20, n=26,23,19,18,16 | 2 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 20, n=26,23,19,18,16 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 16, n=28,26,22,19,19 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 12, n=32,29,24,22,22 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 24, n=23,21,16,17,16 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 4, n=37,37,25,23,27 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 28, n=19,18,12,14,14 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 32, n=19,15,10,12,13 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 2, n=38, 39,26,25,27 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 48, n=9,8,5,8,5 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 40, n=15,11,9,10,10 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 36, n=15,13,10,12,13 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 8, n=34,32,24,23,23 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 52, n=9,5,5,5,4 | 0 Number of Hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 44, n=11,11,6,8,9 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 20, n=26,23,19,18,16 | 1 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 2, n=38, 39,26,25,27 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 4, n=37,37,25,23,27 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 8, n=34,32,24,23,23 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 12, n=32,29,24,22,22 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 16, n=28,26,22,19,19 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 24, n=23,21,16,17,16 | 1 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 28, n=19,18,12,14,14 | 1 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 32, n=19,15,10,12,13 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 36, n=15,13,10,12,13 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 40, n=15,11,9,10,10 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 44, n=11,11,6,8,9 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 48, n=9,8,5,8,5 | 0 Number of Hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 52, n=9,5,5,5,4 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 20, n=26,23,19,18,16 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 32, n=19,15,10,12,13 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 16, n=28,26,22,19,19 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 36, n=15,13,10,12,13 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 12, n=32,29,24,22,22 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 2, n=38, 39,26,25,27 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 40, n=15,11,9,10,10 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 8, n=34,32,24,23,23 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 44, n=11,11,6,8,9 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 4, n=37,37,25,23,27 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 52, n=9,5,5,5,4 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 24, n=23,21,16,17,16 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 48, n=9,8,5,8,5 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 28, n=19,18,12,14,14 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 24, n=23,21,16,17,16 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 52, n=9,5,5,5,4 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 32, n=19,15,10,12,13 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 16, n=28,26,22,19,19 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 28, n=19,18,12,14,14 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 2, n=38, 39,26,25,27 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 44, n=11,11,6,8,9 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 36, n=15,13,10,12,13 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 12, n=32,29,24,22,22 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 4, n=37,37,25,23,27 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 20, n=26,23,19,18,16 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 48, n=9,8,5,8,5 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 40, n=15,11,9,10,10 | 0 Number of Hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Hospitalizations for Disease Flare Over Time | Week 8, n=34,32,24,23,23 | 0 Number of Hospitalizations |
Secondary
Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.
Time frame: Up to 52 weeks
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any AE | 41 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any Corticosteroid related AE | 18 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any SAE | 8 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any SAE | 6 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any AE | 36 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any Corticosteroid related AE | 21 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any SAE | 6 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any AE | 25 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any Corticosteroid related AE | 15 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any AE | 26 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any Corticosteroid related AE | 13 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any SAE | 5 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any SAE | 6 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any AE | 24 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs | Any Corticosteroid related AE | 12 Participants |
Secondary
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 2, n=38, 39,26,25,27 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 32, n=19,15,10,12,13 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 24, n=23,21,16,17,16 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 28, n=19,18,12,14,14 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 48, n=9,8,5,8,5 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 8, n=34,32,24,23,23 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 44, n=11,11,6,8,9 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 12, n=32,29,24,22,22 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 52, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 40, n=15,11,9,10,10 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 16, n=28,26,22,19,19 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 4, n=37,37,25,23,27 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 36, n=15,13,10,12,13 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 20, n=26,23,19,18,16 | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 20, n=26,23,19,18,16 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 16, n=28,26,22,19,19 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 12, n=32,29,24,22,22 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 24, n=23,21,16,17,16 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 4, n=37,37,25,23,27 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 28, n=19,18,12,14,14 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 32, n=19,15,10,12,13 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 2, n=38, 39,26,25,27 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 48, n=9,8,5,8,5 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 40, n=15,11,9,10,10 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 36, n=15,13,10,12,13 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 8, n=34,32,24,23,23 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 52, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 44, n=11,11,6,8,9 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 20, n=26,23,19,18,16 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 2, n=38, 39,26,25,27 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 4, n=37,37,25,23,27 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 8, n=34,32,24,23,23 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 12, n=32,29,24,22,22 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 16, n=28,26,22,19,19 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 24, n=23,21,16,17,16 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 28, n=19,18,12,14,14 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 32, n=19,15,10,12,13 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 36, n=15,13,10,12,13 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 40, n=15,11,9,10,10 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 44, n=11,11,6,8,9 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 48, n=9,8,5,8,5 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 52, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 20, n=26,23,19,18,16 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 32, n=19,15,10,12,13 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 16, n=28,26,22,19,19 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 36, n=15,13,10,12,13 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 12, n=32,29,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 2, n=38, 39,26,25,27 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 40, n=15,11,9,10,10 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 8, n=34,32,24,23,23 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 44, n=11,11,6,8,9 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 4, n=37,37,25,23,27 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 52, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 24, n=23,21,16,17,16 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 48, n=9,8,5,8,5 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 28, n=19,18,12,14,14 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 24, n=23,21,16,17,16 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 52, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 32, n=19,15,10,12,13 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 16, n=28,26,22,19,19 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 28, n=19,18,12,14,14 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 2, n=38, 39,26,25,27 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 44, n=11,11,6,8,9 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 36, n=15,13,10,12,13 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 12, n=32,29,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 4, n=37,37,25,23,27 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 20, n=26,23,19,18,16 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 48, n=9,8,5,8,5 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 40, n=15,11,9,10,10 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Week 8, n=34,32,24,23,23 | 0 Participants |
Secondary
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Time frame: Weeks 12, 24 and 52
Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Better, n=31,28,24,22,22 | 11 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Better, n=31,28,24,22,22 | 11 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12, Slightly Better, n=31,28,24,22,22 | 3 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Better, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Worse, n=31,28,24,22,22 | 2 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Slightly Better,n=23,20,15,17,16 | 2 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Slightly Worse, n=23,20,15,17,16 | 2 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Better, n=9,5,5,5,4 | 2 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,No Change, n=31,28,24,22,22 | 3 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,No Change, n=23,20,15,17,16 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Better, n=9,5,5,5,4 | 6 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Much Better, n=23,20,15,17,16 | 11 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,No Change, n=9,5,5,5,4 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Slightly Worse, n=31,28,24,22,22 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Much Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Better, n=23,20,15,17,16 | 7 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Better, n=23,20,15,17,16 | 8 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Worse,n=23,20,15,17,16 | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Slightly Better,n=23,20,15,17,16 | 2 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Slightly Worse, n=23,20,15,17,16 | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,No Change, n=23,20,15,17,16 | 2 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12, Slightly Better, n=31,28,24,22,22 | 5 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,No Change, n=31,28,24,22,22 | 3 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,No Change, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Slightly Worse, n=31,28,24,22,22 | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Better, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Worse, n=31,28,24,22,22 | 2 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Better, n=31,28,24,22,22 | 10 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Better, n=9,5,5,5,4 | 2 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Better, n=31,28,24,22,22 | 7 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Better, n=9,5,5,5,4 | 3 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Much Better, n=23,20,15,17,16 | 6 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Much Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,No Change, n=23,20,15,17,16 | 2 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Better, n=31,28,24,22,22 | 2 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Better, n=31,28,24,22,22 | 11 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12, Slightly Better, n=31,28,24,22,22 | 4 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,No Change, n=31,28,24,22,22 | 4 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Slightly Worse, n=31,28,24,22,22 | 2 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Worse, n=31,28,24,22,22 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Much Better, n=23,20,15,17,16 | 6 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Better, n=23,20,15,17,16 | 4 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Slightly Better,n=23,20,15,17,16 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Slightly Worse, n=23,20,15,17,16 | 2 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Worse,n=23,20,15,17,16 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Much Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Better, n=9,5,5,5,4 | 3 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Better, n=9,5,5,5,4 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Better, n=9,5,5,5,4 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,No Change, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Much Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Much Better, n=23,20,15,17,16 | 5 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,No Change, n=31,28,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Better, n=31,28,24,22,22 | 5 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,No Change, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Worse, n=31,28,24,22,22 | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12, Slightly Better, n=31,28,24,22,22 | 8 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Better, n=9,5,5,5,4 | 2 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,No Change, n=23,20,15,17,16 | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Slightly Worse, n=31,28,24,22,22 | 4 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Slightly Better,n=23,20,15,17,16 | 4 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Slightly Worse, n=23,20,15,17,16 | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Better, n=9,5,5,5,4 | 2 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Better, n=9,5,5,5,4 | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Better, n=23,20,15,17,16 | 6 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Better, n=31,28,24,22,22 | 4 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Better, n=31,28,24,22,22 | 11 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Worse,n=23,20,15,17,16 | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Much Better, n=23,20,15,17,16 | 6 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Much Worse,n=23,20,15,17,16 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Better, n=9,5,5,5,4 | 3 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Better, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Slightly Worse, n=31,28,24,22,22 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,Much Better, n=31,28,24,22,22 | 5 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Better, n=9,5,5,5,4 | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12,No Change, n=31,28,24,22,22 | 3 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,No Change, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 12, Slightly Better, n=31,28,24,22,22 | 3 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Much Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 52,Slightly Worse, n=9,5,5,5,4 | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,No Change, n=23,20,15,17,16 | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24, Slightly Better,n=23,20,15,17,16 | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Slightly Worse, n=23,20,15,17,16 | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time | Week 24,Better, n=23,20,15,17,16 | 6 Participants |
Secondary
Part A: Time to First Disease Flare After Clinical Remission
Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.
Time frame: Week 52
Population: ITT Population. Only participants who achieved clinical remission were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part A: Time to First Disease Flare After Clinical Remission | NA Days |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part A: Time to First Disease Flare After Clinical Remission | NA Days |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part A: Time to First Disease Flare After Clinical Remission | NA Days |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part A: Time to First Disease Flare After Clinical Remission | NA Days |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part A: Time to First Disease Flare After Clinical Remission | NA Days |
Secondary
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role Physical | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Component Summary | -2.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | 15 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, General health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Functioning | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Social Functioning | 12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Bodily Pain | 49 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role emotional | 8.33 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Bodily Pain | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental Component Summary | 1.88 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental Component Summary | 1.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, General health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental Component Summary | 3.61 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Functioning | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role Physical | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | 4.88 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental health | 25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Component Summary | 0.77 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental health | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Component Summary | -3.17 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role Physical | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental Component Summary | 1.62 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | 18.75 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, General health | -10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, General health | 8 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, General health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Bodily Pain | -16 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | -1.45 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Vitality | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Functioning | 15 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role Physical | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Social Functioning | -12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, General health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Social Functioning | -12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role Physical | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role emotional | 16.67 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Component Summary | -0.12 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, General health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Bodily Pain | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental Component Summary | 3.18 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, General health | -22 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental health | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Social Functioning | -12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Functioning | 25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Functioning | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role emotional | 8.33 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role Physical | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Component Summary | -0.01 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Component Summary | -2.26 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Component Summary | 12.88 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role Physical | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental Component Summary | -5.75 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental Component Summary | 2.26 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, General health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Bodily Pain | 16 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, General health | 8 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental Component Summary | 0.83 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Component Summary | 0.95 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role Physical | 12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental health | -15 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Functioning | 15 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Component Summary | 7.95 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental Component Summary | -6.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Component Summary | 3.22 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role Physical | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role emotional | 25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Functioning | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental health | -15 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental Component Summary | 0.02 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Component Summary | -3.24 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental health | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role Physical | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Bodily Pain | 16 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental Component Summary | -3.68 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental health | -10 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, General health | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Social Functioning | 12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Component Summary | -3.33 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental Component Summary | -2.88 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role Physical | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, General health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Functioning | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role Physical | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Bodily Pain | -22 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, General health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Vitality | -12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, General health | -3 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Bodily Pain | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, General health | -13 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Vitality | -6.25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Social Functioning | -25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role emotional | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role Physical | 6.25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Bodily Pain | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, General health | -8 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Vitality | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Social Functioning | -37.5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Functioning | -5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role Physical | -6.25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Bodily Pain | -11 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, General health | -5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Vitality | 6.25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Social Functioning | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role emotional | -16.67 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental health | 5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Component Summary | -2.76 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Bodily Pain | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Functioning | -29.99 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role Physical | -18.75 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental health | 5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Component Summary | -9.37 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental Component Summary | 1.44 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Functioning | -15.01 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role emotional | 9 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental health | 10 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Component Summary | -3.64 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental Component Summary | -0.4 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental Component Summary | 0.13 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Functioning | 5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role Physical | -12.5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, General health | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Vitality | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Social Functioning | -12.5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role emotional | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental health | -25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Component Summary | 2.16 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental Component Summary | -7.59 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, General health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role Physical | -18.75 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role Physical | 50 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Bodily Pain | 33 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, General health | 5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Vitality | 6.25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Social Functioning | 25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Functioning | -5.01 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Social Functioning | -37.5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role emotional | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental health | 15 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Component Summary | -7.54 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental Component Summary | 3.62 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Bodily Pain | -32 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Functioning | 4.99 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role emotional | 50 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, General health | 10 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental health | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Component Summary | 7.93 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Vitality | 12.5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental Component Summary | 8.48 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, General health | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Vitality | 6.25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Social Functioning | -12.5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Functioning | 5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, General health | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Vitality | -6.25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Social Functioning | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role emotional | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Bodily Pain | 28 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, General health | -20 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Vitality | -6.25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Social Functioning | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role emotional | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role Physical | -25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Bodily Pain | -10 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental Component Summary | -2.21 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Functioning | -10 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Role emotional | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental health | 5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Physical Component Summary | -6.51 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85, Mental Component Summary | 3.01 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Role Physical | 6.25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental Component Summary | -2.52 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Bodily Pain | 28 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Mental health | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12, Physical Component Summary | 5.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Functioning | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Role Physical | 12.5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Mental health | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112, Physical Component Summary | 2.71 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Mental health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Role emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113, General health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373, General health | NA Scores on scale |
Secondary
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Health | -20 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Emotional | -8.33 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Component Summary | -8.76 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Component Summary | 3.29 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Functioning | -4.99 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Component Summary | -2.09 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Component Summary | -0.76 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Functioning | 9.99 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Physical | 37.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Functioning | 4.99 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Physical | 50 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bodily Pain | 49 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, General Health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Health | -10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Component Summary | 15.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Functioning | 24.99 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Component Summary | 17.37 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Component Summary | -10.18 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Functioning | -5.01 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Physical | 37.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Health | -15 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Component Summary | 8.12 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Component Summary | -4.89 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Component Summary | 168 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Social Functioning | 12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Vitality | 6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, General Health | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Physical | 50 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bodily Pain | 33 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Component Summary | -5.84 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Social Functioning | 12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, General Health | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Component Summary | -2.78 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Component Summary | 9.98 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Physical | -12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Physical | -12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bodily Pain | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, General Health | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Vitality | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Functioning | -10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Social Functioning | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Emotional | -16.67 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bodily Pain | -39 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Health | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bodily Pain | 23 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Social Functioning | 12.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, General Health | 10 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, General Health | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bodily Pain | 11 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Bodily Pain | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, General Health | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Vitality | -6.25 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Emotional | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Functioning | -10 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Physical | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Component Summary | -1.05 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Component Summary | -1.72 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Health | -5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Physical | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Emotional | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Vitality | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, General Health | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Functioning | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | 15 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | 6.25 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Health | 5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | 6.28 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, General Health | -5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Emotional | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | -1.59 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bodily Pain | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Vitality | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Physical | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Emotional | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, General Health | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Social Functioning | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | 33 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Component Summary | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Vitality | 6.25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Component Summary | -5.17 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Component Summary | 5.95 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Functioning | 5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Emotional | -16.66 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Component Summary | -5.35 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Functioning | 10.01 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Physical | -18.75 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Bodily Pain | -16 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Component Summary | -1.62 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Component Summary | -8.24 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Functioning | -15 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Physical | -25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Health | 20 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Physical | -18.75 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Social Functioning | -25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Health | 5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, General Health | 10 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Vitality | -12.5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Bodily Pain | 22 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, General Health | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Component Summary | -0.34 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Vitality | -6.25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Social Functioning | -25 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Social Functioning | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, General Health | -7 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Emotional | -33.33 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Emotional | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Health | -5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Bodily Pain | -16 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Health | 5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Functioning | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Component Summary | 4.54 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Social Functioning | 12.5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Emotional | 16.66 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Bodily Pain | -22 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Mental Health | 5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Component Summary | -4.79 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Vitality | -12.5 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Mental Component Summary | 1.82 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Physical Component Summary | 1.52 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, General Health | 10 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Physical Functioning | -10.01 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, General Health | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Role Physical | 6.25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, General Health | 10 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, Mental Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Vitality | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, Role Physical | -6.25 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Role Emotional | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Role Physical | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, Bodily Pain | 21 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Social Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Bodily Pain | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Physical Functioning | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, General Health | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Vitality | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, Physical Component Summary | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, General Health | NA Scores on scale |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 4,n=3,3,2,1,2 | -0.3 Grams per liter | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 8,n=2,1,2,0,2 | 1.5 Grams per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 12,n=1,1,1,1,1 | 3.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 4,n=3,3,2,1,2 | -0.3 Grams per liter | Standard Deviation 3.21 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 8,n=2,1,2,0,2 | 1.5 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 12,n=1,1,1,1,1 | 3.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 8,n=2,1,2,0,2 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 12,n=1,1,1,1,1 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 16,n=0,1,1,1,0 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 24,n=0,1,0,0,0 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 36,n=0,1,0,0,0 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 4,n=3,3,2,1,2 | -2.7 Grams per liter | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 24,n=0,1,0,0,0 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 8,n=2,1,2,0,2 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 36,n=0,1,0,0,0 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 12,n=1,1,1,1,1 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 4,n=3,3,2,1,2 | -1.3 Grams per liter | Standard Deviation 0.58 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 16,n=0,1,1,1,0 | -2.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 8,n=2,1,2,0,2 | 2.5 Grams per liter | Standard Deviation 4.95 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 8,n=2,1,2,0,2 | 1.0 Grams per liter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 12,n=1,1,1,1,1 | 5.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 16,n=0,1,1,1,0 | 12.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 4,n=3,3,2,1,2 | 1.0 Grams per liter | Standard Deviation 5.66 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 12,n=1,1,1,1,1 | 9.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 16,n=0,1,1,1,0 | 5.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 4,n=3,3,2,1,2 | 1.0 Grams per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 4,n=3,3,2,1,2 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 16,n=0,1,1,1,0 | -1.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 12,n=1,1,1,1,1 | 1.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 4,n=3,3,2,1,2 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 12,n=1,1,1,1,1 | 3.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 16,n=0,1,1,1,0 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 4,n=3,3,2,1,2 | -5.0 Grams per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 12,n=1,1,1,1,1 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 4,n=3,3,2,1,2 | -2.5 Grams per liter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 12,n=1,1,1,1,1 | 2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Protein,Week 8,n=2,1,2,0,2 | -1.5 Grams per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Albumin,Week 8,n=2,1,2,0,2 | -1.5 Grams per liter | Standard Deviation 0.71 |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 40,n=1,0,0,0,0 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 16,n=2,0,0,1,0 | -0.5 Grams per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 8,n=2,1,1,2,1 | 3.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 24,n=2,0,0,0,0 | -0.5 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 36,n=2,0,0,0,0 | -1.0 Grams per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 38,n=1,0,0,0,0 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 2,n=1,1,0,1,2 | 0.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 4,n=2,1,1,2,2 | 1.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 4,n=2,1,1,2,2 | 0.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 36,n=2,0,0,0,0 | 1.5 Grams per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 24,n=2,0,0,0,0 | 0.5 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 8,n=2,1,1,2,1 | 1.0 Grams per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 40,n=1,0,0,0,0 | 0.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 16,n=2,0,0,1,0 | 1.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 12,n=2,0,1,1,0 | 2.5 Grams per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 12,n=2,0,1,1,0 | 1.0 Grams per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 38,n=1,0,0,0,0 | 1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 2,n=1,1,0,1,2 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 2,n=1,1,0,1,2 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 4,n=2,1,1,2,2 | 0.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 8,n=2,1,1,2,1 | 0.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 8,n=2,1,1,2,1 | 0.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 4,n=2,1,1,2,2 | 0.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 2,n=1,1,0,1,2 | -1.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 8,n=2,1,1,2,1 | 2.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 4,n=2,1,1,2,2 | -1.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 8,n=2,1,1,2,1 | 0.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 12,n=2,0,1,1,0 | 1.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 4,n=2,1,1,2,2 | -2.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 12,n=2,0,1,1,0 | 2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 2,n=1,1,0,1,2 | 8.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 4,n=2,1,1,2,2 | -0.5 Grams per liter | Standard Deviation 4.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 2,n=1,1,0,1,2 | 5.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 12,n=2,0,1,1,0 | -4.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 14,n=0,0,0,1,0 | -5.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 8,n=2,1,1,2,1 | -2.0 Grams per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 16,n=2,0,0,1,0 | -2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 4,n=2,1,1,2,2 | 0.0 Grams per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 16,n=2,0,0,1,0 | 2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 14,n=0,0,0,1,0 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 12,n=2,0,1,1,0 | -4.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 8,n=2,1,1,2,1 | -2.5 Grams per liter | Standard Deviation 4.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 4,n=2,1,1,2,2 | -0.5 Grams per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 8,n=2,1,1,2,1 | 2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 2,n=1,1,0,1,2 | 3.5 Grams per liter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 2,n=1,1,0,1,2 | 1.5 Grams per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Albumin,Week 4,n=2,1,1,2,2 | 3.0 Grams per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Protein,Week 8,n=2,1,1,2,1 | 0.0 Grams per liter | — |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 4,n=3,3,2,1,2 | 0.7 International units per liter | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 12,n=1,1,1,1,1 | 1.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 4,n=3,3,2,1,2 | -0.7 International units per liter | Standard Deviation 3.79 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 12,n=1,1,1,1,1 | 3.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 12,n=1,1,1,1,1 | -1.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 8,n=2,1,2,0,2 | 10.5 International units per liter | Standard Deviation 9.19 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 4,n=3,3,2,1,2 | 2.3 International units per liter | Standard Deviation 1.15 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 8,n=2,1,2,0,2 | 1.5 International units per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 8,n=2,1,2,0,2 | 9.0 International units per liter | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 12,n=1,1,1,1,1 | -1.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 16,n=0,1,1,1,0 | -5.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 36,n=0,1,0,0,0 | -3.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 8,n=2,1,2,0,2 | 7.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 24,n=0,1,0,0,0 | 0.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 36,n=0,1,0,0,0 | -4.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 4,n=3,3,2,1,2 | 0.0 International units per liter | Standard Deviation 4.36 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 24,n=0,1,0,0,0 | -1.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 4,n=3,3,2,1,2 | 2.0 International units per liter | Standard Deviation 3 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 8,n=2,1,2,0,2 | -1.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 12,n=1,1,1,1,1 | 0.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 8,n=2,1,2,0,2 | 13.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 36,n=0,1,0,0,0 | 4.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 24,n=0,1,0,0,0 | 2.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 16,n=0,1,1,1,0 | 4.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 4,n=3,3,2,1,2 | 2.7 International units per liter | Standard Deviation 7.23 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 16,n=0,1,1,1,0 | -4.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 12,n=1,1,1,1,1 | 8.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 12,n=1,1,1,1,1 | 2.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 4,n=3,3,2,1,2 | -8.0 International units per liter | Standard Deviation 4.24 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 8,n=2,1,2,0,2 | -9.5 International units per liter | Standard Deviation 9.19 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 12,n=1,1,1,1,1 | -4.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 16,n=0,1,1,1,0 | -6.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 4,n=3,3,2,1,2 | 0.5 International units per liter | Standard Deviation 3.54 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 8,n=2,1,2,0,2 | -1.0 International units per liter | Standard Deviation 4.24 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 12,n=1,1,1,1,1 | 17.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 16,n=0,1,1,1,0 | 3.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 4,n=3,3,2,1,2 | -5.0 International units per liter | Standard Deviation 1.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 8,n=2,1,2,0,2 | -6.0 International units per liter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 16,n=0,1,1,1,0 | 0.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 12,n=1,1,1,1,1 | -11.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 16,n=0,1,1,1,0 | 2.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 4,n=3,3,2,1,2 | 24.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 4,n=3,3,2,1,2 | 81.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 16,n=0,1,1,1,0 | 1.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 12,n=1,1,1,1,1 | 0.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 12,n=1,1,1,1,1 | 0.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 4,n=3,3,2,1,2 | 103.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 16,n=0,1,1,1,0 | -10.0 International units per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 12,n=1,1,1,1,1 | -10.0 International units per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 4,n=3,3,2,1,2 | 0.0 International units per liter | Standard Deviation 14.14 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 8,n=2,1,2,0,2 | 0.0 International units per liter | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALP,Week 8,n=2,1,2,0,2 | -3.0 International units per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 4,n=3,3,2,1,2 | -1.5 International units per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | AST,Week 12,n=1,1,1,1,1 | 2.0 International units per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 8,n=2,1,2,0,2 | -1.5 International units per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 4,n=3,3,2,1,2 | 1.0 International units per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | ALT,Week 12,n=1,1,1,1,1 | 2.0 International units per liter | — |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 16,n=2,0,0,1,0 | -1.0 International units per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 4,n=2,1,1,2,2 | -1.5 International units per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 8,n=2,1,1,2,2 | 2.5 International units per liter | Standard Deviation 4.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 12,n=2,0,1,1,0 | -3.0 International units per liter | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 2,n=1,1,0,1,2 | 1.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 24,n=2,0,0,0,0 | -2.5 International units per liter | Standard Deviation 6.36 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 36,n=2,0,0,0,0 | -4.5 International units per liter | Standard Deviation 9.19 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 38,n=1,0,0,0,0 | -9.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 40,n=1,0,0,0,0 | -9.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 2,n=1,1,0,1,2 | 7.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 4,n=2,1,1,2,2 | 5.5 International units per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 8,n=2,1,1,2,2 | 7.0 International units per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 12,n=2,0,1,1,0 | 5.0 International units per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 16,n=2,0,0,1,0 | -0.5 International units per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 24,n=2,0,0,0,0 | 2.5 International units per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 36,n=2,0,0,0,0 | 2.0 International units per liter | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 38,n=1,0,0,0,0 | 7.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 40,n=1,0,0,0,0 | 18.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 2,n=1,1,0,1,2 | 0.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 4,n=2,1,1,2,2 | -4.5 International units per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 8,n=2,1,1,2,2 | 1.5 International units per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 12,n=2,0,1,1,0 | -4.0 International units per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 16,n=2,0,0,1,0 | -3.0 International units per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 24,n=2,0,0,0,0 | -3.5 International units per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 36,n=2,0,0,0,0 | -4.5 International units per liter | Standard Deviation 4.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 38,n=1,0,0,0,0 | -7.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 40,n=1,0,0,0,0 | -7.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 4,n=2,1,1,2,2 | -9.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 8,n=2,1,1,2,2 | 2.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 4,n=2,1,1,2,2 | 4.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 2,n=1,1,0,1,2 | 0.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 2,n=1,1,0,1,2 | -2.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 4,n=2,1,1,2,2 | 0.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 8,n=2,1,1,2,2 | -2.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 8,n=2,1,1,2,2 | -16.0 International units per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 2,n=1,1,0,1,2 | 4.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 8,n=2,1,1,2,2 | -3.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 4,n=2,1,1,2,2 | -4.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 12,n=2,0,1,1,0 | 4.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 4,n=2,1,1,2,2 | 0.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 12,n=2,0,1,1,0 | -1.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 8,n=2,1,1,2,2 | 1.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 12,n=2,0,1,1,0 | 2.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 4,n=2,1,1,2,2 | 0.0 International units per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 8,n=2,1,1,2,2 | -3.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 12,n=2,0,1,1,0 | -3.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 4,n=2,1,1,2,2 | -0.5 International units per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 4,n=2,1,1,2,2 | -9.0 International units per liter | Standard Deviation 14.14 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 8,n=2,1,1,2,2 | -4.5 International units per liter | Standard Deviation 26.16 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 14,n=0,0,0,1,0 | 0.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 12,n=2,0,1,1,0 | 8.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 14,n=0,0,0,1,0 | -15.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 16,n=2,0,0,1,0 | -9.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 8,n=2,1,1,2,2 | 2.0 International units per liter | Standard Deviation 4.24 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 2,n=1,1,0,1,2 | 3.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 4,n=2,1,1,2,2 | 4.0 International units per liter | Standard Deviation 9.9 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 16,n=2,0,0,1,0 | 1.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 8,n=2,1,1,2,2 | 4.5 International units per liter | Standard Deviation 7.78 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 14,n=0,0,0,1,0 | 2.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 16,n=2,0,0,1,0 | 2.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 2,n=1,1,0,1,2 | 3.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 12,n=2,0,1,1,0 | -2.0 International units per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 2,n=1,1,0,1,2 | -17.0 International units per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 2,n=1,1,0,1,2 | 72.5 International units per liter | Standard Deviation 101.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 8,n=2,1,1,2,2 | -12.0 International units per liter | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 4,n=2,1,1,2,2 | 23.0 International units per liter | Standard Deviation 25.46 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 2,n=1,1,0,1,2 | 44.5 International units per liter | Standard Deviation 57.28 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 8,n=2,1,1,2,2 | 31.5 International units per liter | Standard Deviation 24.75 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALT,Week 4,n=2,1,1,2,2 | 51.5 International units per liter | Standard Deviation 64.35 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | AST,Week 8,n=2,1,1,2,2 | 14.0 International units per liter | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 2,n=1,1,0,1,2 | -5.0 International units per liter | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | ALP,Week 4,n=2,1,1,2,2 | -7.0 International units per liter | Standard Deviation 5.66 |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | 0.7 Micromoles per liter | Standard Deviation 3.06 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 12,n=1,1,1,1,1 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,2,0,2 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 8,n=2,1,2,0,2 | -8.40 Micromoles per liter | Standard Deviation 0.566 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 4,n=3,3,2,1,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 4,n=3,3,2,1,2 | -7.07 Micromoles per liter | Standard Deviation 7.887 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,2,0,2 | 3.0 Micromoles per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 4,n=3,3,2,1,2 | 0.7 Micromoles per liter | Standard Deviation 3.06 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | 2.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 12,n=1,1,1,1,1 | 4.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 12,n=1,1,1,1,1 | -6.20 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 36,n=0,1,0,0,0 | -21.20 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 4,n=3,3,2,1,2 | 1.3 Micromoles per liter | Standard Deviation 3.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,2,0,2 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 12,n=1,1,1,1,1 | -2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 16,n=0,1,1,1,0 | -2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 24,n=0,1,0,0,0 | -2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 36,n=0,1,0,0,0 | -4.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 4,n=3,3,2,1,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,2,0,2 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 12,n=1,1,1,1,1 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 16,n=0,1,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 24,n=0,1,0,0,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 36,n=0,1,0,0,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | 1.3 Micromoles per liter | Standard Deviation 3.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | -4.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 16,n=0,1,1,1,0 | -2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 24,n=0,1,0,0,0 | -2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 36,n=0,1,0,0,0 | -4.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 4,n=3,3,2,1,2 | -0.63 Micromoles per liter | Standard Deviation 4.842 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 8,n=2,1,2,0,2 | -18.60 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 12,n=1,1,1,1,1 | -27.40 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 16,n=0,1,1,1,0 | -19.50 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 24,n=0,1,0,0,0 | -27.40 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 4,n=3,3,2,1,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 12,n=1,1,1,1,1 | 5.30 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 16,n=0,1,1,1,0 | -2.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 16,n=0,1,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | -5.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 16,n=0,1,1,1,0 | 5.30 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 16,n=0,1,1,1,0 | -2.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 12,n=1,1,1,1,1 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,2,0,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 4,n=3,3,2,1,2 | -5.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | -4.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 4,n=3,3,2,1,2 | -1.30 Micromoles per liter | Standard Deviation 9.334 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,2,0,2 | -4.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 8,n=2,1,2,0,2 | -5.25 Micromoles per liter | Standard Deviation 3.748 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | 2.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 12,n=1,1,1,1,1 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 12,n=1,1,1,1,1 | 9.70 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 16,n=0,1,1,1,0 | 5.30 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | 4.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 16,n=0,1,1,1,0 | 4.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 16,n=0,1,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 16,n=0,1,1,1,0 | 4.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 4,n=3,3,2,1,2 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 12,n=1,1,1,1,1 | 4.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 4,n=3,3,2,1,2 | -0.90 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 12,n=1,1,1,1,1 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 4,n=3,3,2,1,2 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 4,n=3,3,2,1,2 | -2.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 12,n=1,1,1,1,1 | -8.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,2,0,2 | -4.0 Micromoles per liter | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,2,0,2 | -6.0 Micromoles per liter | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,2,0,2 | -2.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 8,n=2,1,2,0,2 | -5.75 Micromoles per liter | Standard Deviation 5.728 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Direct Bilirubin,Week 12,n=1,1,1,1,1 | -2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Bilirubin,Week 4,n=3,3,2,1,2 | -8.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 12,n=1,1,1,1,1 | -19.50 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Creatinine,Week 4,n=3,3,2,1,2 | 3.95 Micromoles per liter | Standard Deviation 19.445 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=1,1,1,1,1 | -6.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=3,3,2,1,2 | -6.0 Micromoles per liter | Standard Deviation 2.83 |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 4,n=2,1,1,2,2 | 5.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 38,n=1,0,0,0,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 40,n=1,0,0,0,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 16,n=2,0,0,1,0 | 4.0 Micromoles per liter | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 24,n=2,0,0,0,0 | -2.0 Micromoles per liter | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 36,n=2,0,0,0,0 | 2.0 Micromoles per liter | Standard Deviation 8.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 38,n=1,0,0,0,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 40,n=1,0,0,0,0 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 2,n=1,1,0,1,2 | -3.50 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 4,n=2,1,1,2,2 | -11.05 Micromoles per liter | Standard Deviation 9.405 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 16,n=2,0,0,1,0 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,1,2,1 | 0.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 8,n=2,1,1,2,1 | -8.40 Micromoles per liter | Standard Deviation 6.93 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 12,n=2,0,1,1,0 | -11.90 Micromoles per liter | Standard Deviation 11.879 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | 4.0 Micromoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 16,n=2,0,0,1,0 | -12.80 Micromoles per liter | Standard Deviation 5.657 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 24,n=2,0,0,0,0 | -9.75 Micromoles per liter | Standard Deviation 12.516 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 36,n=2,0,0,0,0 | -15.05 Micromoles per liter | Standard Deviation 9.97 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 38,n=1,0,0,0,0 | -19.40 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 40,n=1,0,0,0,0 | -20.30 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 24,n=2,0,0,0,0 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 4,n=2,1,1,2,2 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,1,2,2 | -1.0 Micromoles per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | -1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | Standard Deviation 8.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 16,n=2,0,0,1,0 | 5.0 Micromoles per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 36,n=2,0,0,0,0 | -1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 24,n=2,0,0,0,0 | -2.0 Micromoles per liter | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 36,n=2,0,0,0,0 | 1.0 Micromoles per liter | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 38,n=1,0,0,0,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 40,n=1,0,0,0,0 | 2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 8,n=2,1,1,2,1 | -8.00 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,1,2,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 4,n=2,1,1,2,2 | -2.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 2,n=1,1,0,1,2 | -6.20 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,1,2,1 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 4,n=2,1,1,2,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 4,n=2,1,1,2,2 | -12.40 Micromoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | -2.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 12,n=2,0,1,1,0 | 4.40 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 8,n=2,1,1,2,1 | 9.70 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 4,n=2,1,1,2,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,1,2,2 | 2.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,1,2,1 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 4,n=2,1,1,2,2 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 4,n=2,1,1,2,2 | 2.70 Micromoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 14,n=0,0,0,1,0 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 16,n=2,0,0,1,0 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | 0.0 Micromoles per liter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 12,n=2,0,1,1,0 | -2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 14,n=0,0,0,1,0 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 16,n=2,0,0,1,0 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 2,n=1,1,0,1,2 | 1.80 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 4,n=2,1,1,2,2 | -1.30 Micromoles per liter | Standard Deviation 0.566 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 8,n=2,1,1,2,1 | 0.45 Micromoles per liter | Standard Deviation 5.728 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 12,n=2,0,1,1,0 | -0.90 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 14,n=0,0,0,1,0 | 0.80 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 16,n=2,0,0,1,0 | 4.40 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 2,n=1,1,0,1,2 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 4,n=2,1,1,2,2 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,1,2,2 | 1.0 Micromoles per liter | Standard Deviation 4.24 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 12,n=2,0,1,1,0 | -2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 14,n=0,0,0,1,0 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 16,n=2,0,0,1,0 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 2,n=1,1,0,1,2 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 4,n=2,1,1,2,2 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 12,n=2,0,1,1,0 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,1,2,1 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 2,n=1,1,0,1,2 | -1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 8,n=2,1,1,2,1 | 0.00 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 2,n=1,1,0,1,2 | -1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 4,n=2,1,1,2,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 4,n=2,1,1,2,2 | 2.20 Micromoles per liter | Standard Deviation 4.384 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Creatinine,Week 2,n=1,1,0,1,2 | 3.10 Micromoles per liter | Standard Deviation 1.838 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 8,n=2,1,1,2,1 | 2.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 8,n=2,1,1,2,1 | 0.0 Micromoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 8,n=2,1,1,2,2 | 2.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Indirect Bilirubin,Week 4,n=2,1,1,2,2 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Direct Bilirubin,Week 2,n=1,1,0,1,2 | 0.0 Micromoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Bilirubin,Week 4,n=2,1,1,2,2 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 12,n=1,1,1,1,1 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 8,n=2,1,2,0,2 | 0.15 Millimoles per liter | Standard Deviation 1.061 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,2,0,2 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 8,n=2,1,2,0,2 | 0.010 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 4,n=3,3,2,1,2 | -0.10 Millimoles per liter | Standard Deviation 0.608 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 12,n=1,1,1,1,1 | -2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 12,n=1,1,1,1,1 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 4,n=3,3,2,1,2 | 0.050 Millimoles per liter | Standard Deviation 0.2646 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 8,n=2,1,2,0,2 | -2.0 Millimoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 4,n=3,3,2,1,2 | 0.7 Millimoles per liter | Standard Deviation 1.15 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 12,n=1,1,1,1,1 | -2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 8,n=2,1,2,0,2 | -2.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 12,n=1,1,1,1,1 | 0.020 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 4,n=3,3,2,1,2 | 0.067 Millimoles per liter | Standard Deviation 0.0643 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 4,n=3,3,2,1,2 | 0.3 Millimoles per liter | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 12,n=1,1,1,1,1 | -0.20 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 8,n=2,1,2,0,2 | -0.25 Millimoles per liter | Standard Deviation 0.212 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 4,n=3,3,2,1,2 | 0.0 Millimoles per liter | Standard Deviation 2 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 4,n=3,3,2,1,2 | -0.27 Millimoles per liter | Standard Deviation 0.289 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 12,n=1,1,1,1,1 | 0.050 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 12,n=1,1,1,1,1 | -0.50 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 8,n=2,1,2,0,2 | -0.50 Millimoles per liter | Standard Deviation 0.707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 4,n=3,3,2,1,2 | -0.83 Millimoles per liter | Standard Deviation 0.577 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 8,n=2,1,2,0,2 | 0.150 Millimoles per liter | Standard Deviation 0.1414 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 36,n=0,1,0,0,0 | -1.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 4,n=3,3,2,1,2 | -0.093 Millimoles per liter | Standard Deviation 0.0462 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 8,n=2,1,2,0,2 | -0.060 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 12,n=1,1,1,1,1 | 0.040 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 16,n=0,1,1,1,0 | 0.040 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 24,n=0,1,0,0,0 | -0.040 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 36,n=0,1,0,0,0 | -0.020 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 4,n=3,3,2,1,2 | -2.7 Millimoles per liter | Standard Deviation 1.15 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,2,0,2 | -4.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 12,n=1,1,1,1,1 | -2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 16,n=0,1,1,1,0 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 24,n=0,1,0,0,0 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 36,n=0,1,0,0,0 | -2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 4,n=3,3,2,1,2 | 0.3 Millimoles per liter | Standard Deviation 3.06 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 8,n=2,1,2,0,2 | -1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 12,n=1,1,1,1,1 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 16,n=0,1,1,1,0 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 24,n=0,1,0,0,0 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 36,n=0,1,0,0,0 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 4,n=3,3,2,1,2 | 0.33 Millimoles per liter | Standard Deviation 1.115 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 8,n=2,1,2,0,2 | 0.60 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 12,n=1,1,1,1,1 | 2.80 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 16,n=0,1,1,1,0 | 1.40 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 24,n=0,1,0,0,0 | 1.10 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 36,n=0,1,0,0,0 | 2.10 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 4,n=3,3,2,1,2 | -0.033 Millimoles per liter | Standard Deviation 0.1155 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 8,n=2,1,2,0,2 | -0.100 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 12,n=1,1,1,1,1 | -0.250 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 16,n=0,1,1,1,0 | 0.100 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 24,n=0,1,0,0,0 | 0.050 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 36,n=0,1,0,0,0 | -0.150 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 4,n=3,3,2,1,2 | 0.03 Millimoles per liter | Standard Deviation 0.321 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 8,n=2,1,2,0,2 | -0.30 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 12,n=1,1,1,1,1 | -0.20 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 16,n=0,1,1,1,0 | -0.10 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 24,n=0,1,0,0,0 | -0.10 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 36,n=0,1,0,0,0 | -0.20 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 4,n=3,3,2,1,2 | -1.0 Millimoles per liter | Standard Deviation 2.65 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 8,n=2,1,2,0,2 | 2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 12,n=1,1,1,1,1 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 16,n=0,1,1,1,0 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 24,n=0,1,0,0,0 | 3.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 36,n=0,1,0,0,0 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 4,n=3,3,2,1,2 | -0.50 Millimoles per liter | Standard Deviation 1.323 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 8,n=2,1,2,0,2 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 12,n=1,1,1,1,1 | -1.50 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 16,n=0,1,1,1,0 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 24,n=0,1,0,0,0 | -0.50 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 12,n=1,1,1,1,1 | -4.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 16,n=0,1,1,1,0 | 0.30 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 12,n=1,1,1,1,1 | 0.00 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 16,n=0,1,1,1,0 | -4.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 4,n=3,3,2,1,2 | -0.125 Millimoles per liter | Standard Deviation 0.1768 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 4,n=3,3,2,1,2 | 0.0 Millimoles per liter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 8,n=2,1,2,0,2 | -0.250 Millimoles per liter | Standard Deviation 0.2121 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 12,n=1,1,1,1,1 | 0.000 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 16,n=0,1,1,1,0 | 0.000 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 8,n=2,1,2,0,2 | -0.85 Millimoles per liter | Standard Deviation 0.071 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 16,n=0,1,1,1,0 | 0.180 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 4,n=3,3,2,1,2 | -0.50 Millimoles per liter | Standard Deviation 0.707 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 4,n=3,3,2,1,2 | 0.10 Millimoles per liter | Standard Deviation 0.141 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 8,n=2,1,2,0,2 | 0.00 Millimoles per liter | Standard Deviation 0.424 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 12,n=1,1,1,1,1 | 0.40 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 16,n=0,1,1,1,0 | -0.10 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 16,n=0,1,1,1,0 | -0.50 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 8,n=2,1,2,0,2 | -0.75 Millimoles per liter | Standard Deviation 0.354 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 12,n=1,1,1,1,1 | 0.160 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 16,n=0,1,1,1,0 | 1.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 4,n=3,3,2,1,2 | -3.0 Millimoles per liter | Standard Deviation 2.83 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 4,n=3,3,2,1,2 | -2.5 Millimoles per liter | Standard Deviation 4.95 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 12,n=1,1,1,1,1 | 0.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 8,n=2,1,2,0,2 | -2.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 4,n=3,3,2,1,2 | 0.060 Millimoles per liter | Standard Deviation 0.1414 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 16,n=0,1,1,1,0 | -5.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 8,n=2,1,2,0,2 | -3.5 Millimoles per liter | Standard Deviation 3.54 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,2,0,2 | 0.5 Millimoles per liter | Standard Deviation 3.54 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 8,n=2,1,2,0,2 | 0.050 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 4,n=3,3,2,1,2 | -0.80 Millimoles per liter | Standard Deviation 0.849 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 12,n=1,1,1,1,1 | -4.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 12,n=1,1,1,1,1 | 0.30 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 4,n=3,3,2,1,2 | -1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 12,n=1,1,1,1,1 | 0.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 4,n=3,3,2,1,2 | 0.120 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 16,n=0,1,1,1,0 | 0.50 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 16,n=0,1,1,1,0 | -0.20 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 16,n=0,1,1,1,0 | -1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 12,n=1,1,1,1,1 | 0.000 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 16,n=0,1,1,1,0 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 12,n=1,1,1,1,1 | -0.50 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 12,n=1,1,1,1,1 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 4,n=3,3,2,1,2 | -3.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 16,n=0,1,1,1,0 | 2.10 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 4,n=3,3,2,1,2 | -4.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 4,n=3,3,2,1,2 | 0.050 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 4,n=3,3,2,1,2 | 0.70 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 16,n=0,1,1,1,0 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 16,n=0,1,1,1,0 | 0.060 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 12,n=1,1,1,1,1 | -1.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 12,n=1,1,1,1,1 | 0.250 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 16,n=0,1,1,1,0 | 0.000 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 12,n=1,1,1,1,1 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 12,n=1,1,1,1,1 | -2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 4,n=3,3,2,1,2 | 0.40 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 4,n=3,3,2,1,2 | 0.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 4,n=3,3,2,1,2 | -0.025 Millimoles per liter | Standard Deviation 0.1061 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 4,n=3,3,2,1,2 | -0.25 Millimoles per liter | Standard Deviation 1.061 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 4,n=3,3,2,1,2 | -3.0 Millimoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,2,0,2 | -1.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 12,n=1,1,1,1,1 | -0.40 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 8,n=2,1,2,0,2 | 0.020 Millimoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 4,n=3,3,2,1,2 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 8,n=2,1,2,0,2 | -0.075 Millimoles per liter | Standard Deviation 0.0354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 12,n=1,1,1,1,1 | 0.000 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 8,n=2,1,2,0,2 | 0.55 Millimoles per liter | Standard Deviation 0.354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Carbon Dioxide,Week 12,n=1,1,1,1,1 | -3.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 8,n=2,1,2,0,2 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 8,n=2,1,2,0,2 | -0.10 Millimoles per liter | Standard Deviation 0.283 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 4,n=3,3,2,1,2 | -0.40 Millimoles per liter | Standard Deviation 0.707 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 8,n=2,1,2,0,2 | 0.50 Millimoles per liter | Standard Deviation 0.707 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 12,n=1,1,1,1,1 | -2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Phosphate,Week 12,n=1,1,1,1,1 | -0.100 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Urea,Week 12,n=1,1,1,1,1 | -2.50 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 8,n=2,1,2,0,2 | 0.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Sodium,Week 12,n=1,1,1,1,1 | -4.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Glucose,Week 12,n=1,1,1,1,1 | 0.20 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Potassium,Week 4,n=3,3,2,1,2 | -0.10 Millimoles per liter | Standard Deviation 0.141 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Chloride,Week 4,n=3,3,2,1,2 | 0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Calcium,Week 4,n=3,3,2,1,2 | -0.040 Millimoles per liter | Standard Deviation 0.0566 |
Secondary
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 40,n=1,0,0,0,0 | 1.50 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 2,n=1,1,0,1,2 | 0.060 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 4,n=2,1,1,2,2 | 0.070 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 8,n=2,1,1,2,1 | 0.120 Millimoles per liter | Standard Deviation 0.0283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 12,n=2,1,1,1,0 | 0.110 Millimoles per liter | Standard Deviation 0.099 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 16,n=2,0,0,1,0 | 0.000 Millimoles per liter | Standard Deviation 0.1131 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 24,n=2,0,0,0,0 | 0.040 Millimoles per liter | Standard Deviation 0.0566 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 36,n=2,0,0,0,0 | -0.050 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 38,n=1,0,0,0,0 | -0.020 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 40,n=1,0,0,0,0 | -0.020 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 2,n=1,1,0,1,2 | 3.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 4,n=2,1,1,2,2 | 3.5 Millimoles per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,1,2,1 | 2.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 12,n=2,1,1,1,0 | 3.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 16,n=2,0,0,1,0 | 0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 24,n=2,0,0,0,0 | 3.0 Millimoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 36,n=2,0,0,0,0 | 1.5 Millimoles per liter | Standard Deviation 4.95 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 38,n=1,0,0,0,0 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 40,n=1,0,0,0,0 | -2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 2,n=1,1,0,1,2 | -1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 4,n=2,1,1,2,2 | -2.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 8,n=2,1,1,2,1 | -3.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 12,n=2,1,1,1,0 | -2.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 16,n=2,0,0,1,0 | -1.0 Millimoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 24,n=2,0,0,0,0 | -2.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 36,n=2,0,0,0,0 | 0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 38,n=1,0,0,0,0 | -1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 40,n=1,0,0,0,0 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 2,n=1,1,0,1,2 | 0.80 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 4,n=2,1,1,2,2 | 0.95 Millimoles per liter | Standard Deviation 1.202 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 8,n=2,1,1,2,1 | 0.70 Millimoles per liter | Standard Deviation 0.424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 12,n=2,1,1,1,0 | 0.60 Millimoles per liter | Standard Deviation 0.566 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 16,n=2,0,0,1,0 | 0.55 Millimoles per liter | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 24,n=2,0,0,0,0 | 0.65 Millimoles per liter | Standard Deviation 0.354 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 36,n=2,0,0,0,0 | 0.35 Millimoles per liter | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 38,n=1,0,0,0,0 | 0.50 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 40,n=1,0,0,0,0 | 3.60 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 2,n=1,1,0,1,2 | 0.050 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 4,n=2,1,1,2,2 | -0.125 Millimoles per liter | Standard Deviation 0.1768 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 8,n=2,1,1,2,1 | 0.025 Millimoles per liter | Standard Deviation 0.1061 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 12,n=2,1,1,1,0 | -0.025 Millimoles per liter | Standard Deviation 0.1768 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 16,n=2,0,0,1,0 | -0.050 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 24,n=2,0,0,0,0 | 0.050 Millimoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 36,n=2,0,0,0,0 | -0.025 Millimoles per liter | Standard Deviation 0.0354 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 38,n=1,0,0,0,0 | 0.000 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 40,n=1,0,0,0,0 | 0.000 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 2,n=1,1,0,1,2 | 0.10 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 4,n=2,1,1,2,2 | 0.20 Millimoles per liter | Standard Deviation 0.283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 8,n=2,1,1,2,1 | 0.10 Millimoles per liter | Standard Deviation 0.424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 12,n=2,1,1,1,0 | 0.25 Millimoles per liter | Standard Deviation 0.636 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 16,n=2,0,0,1,0 | 0.00 Millimoles per liter | Standard Deviation 0.141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 24,n=2,0,0,0,0 | 0.40 Millimoles per liter | Standard Deviation 0.283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 36,n=2,0,0,0,0 | 0.20 Millimoles per liter | Standard Deviation 0.424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 38,n=1,0,0,0,0 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 40,n=1,0,0,0,0 | -0.30 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 2,n=1,1,0,1,2 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 4,n=2,1,1,2,2 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 8,n=2,1,1,2,1 | -2.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 12,n=2,1,1,1,0 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 16,n=2,0,0,1,0 | -1.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 24,n=2,0,0,0,0 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 36,n=2,0,0,0,0 | 2.0 Millimoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 38,n=1,0,0,0,0 | -1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 40,n=1,0,0,0,0 | 2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 2,n=1,1,0,1,2 | -1.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 4,n=2,1,1,2,2 | 1.25 Millimoles per liter | Standard Deviation 0.354 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 8,n=2,1,1,2,1 | 2.00 Millimoles per liter | Standard Deviation 2.121 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 12,n=2,1,1,1,0 | -0.50 Millimoles per liter | Standard Deviation 2.121 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 16,n=2,0,0,1,0 | 1.25 Millimoles per liter | Standard Deviation 1.768 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 24,n=2,0,0,0,0 | 0.00 Millimoles per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 36,n=2,0,0,0,0 | 0.00 Millimoles per liter | Standard Deviation 0.707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 38,n=1,0,0,0,0 | 1.50 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 4,n=2,1,1,2,2 | -1.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 8,n=2,1,1,2,1 | 0.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,1,2,1 | -4.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 2,n=1,1,0,1,2 | -0.100 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 2,n=1,1,0,1,2 | -2.50 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 8,n=2,1,1,2,1 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 2,n=1,1,0,1,2 | 0.20 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 2,n=1,1,0,1,2 | -5.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 4,n=2,1,1,2,2 | -3.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 4,n=2,1,1,2,2 | -0.250 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 4,n=2,1,1,2,2 | 1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 8,n=2,1,1,2,1 | -0.200 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 8,n=2,1,1,2,1 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 4,n=2,1,1,2,2 | -1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 8,n=2,1,1,2,1 | -2.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 12,n=2,1,1,1,0 | 0.00 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 2,n=1,1,0,1,2 | 2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 2,n=1,1,0,1,2 | -2.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 2,n=1,1,0,1,2 | -0.20 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 8,n=2,1,1,2,1 | -1.0 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 2,n=1,1,0,1,2 | 0.000 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 4,n=2,1,1,2,2 | 0.40 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 12,n=2,1,1,1,0 | NA Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 4,n=2,1,1,2,2 | -0.20 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 4,n=2,1,1,2,2 | -0.100 Millimoles per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 8,n=2,1,1,2,1 | -0.140 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 12,n=2,1,1,1,0 | 2.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 8,n=2,1,1,2,1 | 0.50 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 8,n=2,1,1,2,1 | 0.150 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 4,n=2,1,1,2,2 | 3.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 4,n=2,1,1,2,2 | 1.50 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 4,n=2,1,1,2,2 | 6.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 4,n=2,1,1,2,2 | 2.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 4,n=2,1,1,2,2 | -0.080 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 8,n=2,1,1,2,1 | 0.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 12,n=2,1,1,1,0 | 0.30 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 4,n=2,1,1,2,2 | 0.20 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 12,n=2,1,1,1,0 | -2.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 8,n=2,1,1,2,1 | 0.000 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 4,n=2,1,1,2,2 | -0.70 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,1,2,1 | 1.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 8,n=2,1,1,2,1 | 0.10 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 12,n=2,1,1,1,0 | 1.50 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 12,n=2,1,1,1,0 | 0.000 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 8,n=2,1,1,2,1 | 3.00 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 4,n=2,1,1,2,2 | 0.000 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 12,n=2,1,1,1,0 | -1.0 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 12,n=2,1,1,1,0 | 0.050 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 12,n=2,1,1,1,0 | 0.00 Millimoles per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 8,n=2,1,1,2,1 | 2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 2,n=1,1,0,1,2 | -2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,1,2,1 | -1.0 Millimoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 2,n=1,1,0,1,2 | 1.30 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 4,n=2,1,1,2,2 | 0.5 Millimoles per liter | Standard Deviation 4.95 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 4,n=2,1,1,2,2 | -0.05 Millimoles per liter | Standard Deviation 2.192 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 8,n=2,1,1,2,1 | 0.30 Millimoles per liter | Standard Deviation 1.414 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 12,n=2,1,1,1,0 | -0.10 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 14,n=0,0,0,1,0 | -0.10 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 16,n=2,0,0,1,0 | -0.20 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 8,n=2,1,1,2,1 | -0.5 Millimoles per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 2,n=1,1,0,1,2 | -0.300 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 4,n=2,1,1,2,2 | 0.050 Millimoles per liter | Standard Deviation 0.2828 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 12,n=2,1,1,1,0 | 2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 8,n=2,1,1,2,1 | -0.075 Millimoles per liter | Standard Deviation 0.3182 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 14,n=0,0,0,1,0 | 2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 12,n=2,1,1,1,0 | 0.200 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 14,n=0,0,0,1,0 | 0.250 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 8,n=2,1,1,2,1 | -0.25 Millimoles per liter | Standard Deviation 0.354 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 16,n=2,0,0,1,0 | 0.300 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 16,n=2,0,0,1,0 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 16,n=2,0,0,1,0 | 1.50 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 2,n=1,1,0,1,2 | 0.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 12,n=2,1,1,1,0 | 0.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 2,n=1,1,0,1,2 | 0.100 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 4,n=2,1,1,2,2 | 0.050 Millimoles per liter | Standard Deviation 0.1273 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 8,n=2,1,1,2,1 | -0.020 Millimoles per liter | Standard Deviation 0.0849 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 4,n=2,1,1,2,2 | -0.30 Millimoles per liter | Standard Deviation 0.141 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 12,n=2,1,1,1,0 | -0.040 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 14,n=0,0,0,1,0 | 0.000 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 16,n=2,0,0,1,0 | 0.140 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 8,n=2,1,1,2,1 | -0.30 Millimoles per liter | Standard Deviation 0.424 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 2,n=1,1,0,1,2 | -2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 2,n=1,1,0,1,2 | 0.50 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 4,n=2,1,1,2,2 | -1.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 12,n=2,1,1,1,0 | -3.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 14,n=0,0,0,1,0 | 1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 12,n=2,1,1,1,0 | 0.10 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 16,n=2,0,0,1,0 | -1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 14,n=0,0,0,1,0 | 0.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 16,n=2,0,0,1,0 | -0.10 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 14,n=0,0,0,1,0 | 1.00 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 2,n=1,1,0,1,2 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 4,n=2,1,1,2,2 | 0.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 4,n=2,1,1,2,2 | 1.50 Millimoles per liter | Standard Deviation 0.707 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 8,n=2,1,1,2,1 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 12,n=2,1,1,1,0 | 1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 14,n=0,0,0,1,0 | 1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 16,n=2,0,0,1,0 | 0.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 2,n=1,1,0,1,2 | 0.75 Millimoles per liter | Standard Deviation 0.354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 8,n=2,1,1,2,1 | 3.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 4,n=2,1,1,2,2 | 0.25 Millimoles per liter | Standard Deviation 0.354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 2,n=1,1,0,1,2 | 0.10 Millimoles per liter | Standard Deviation 0.283 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Urea,Week 8,n=2,1,1,2,1 | 0.50 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 4,n=2,1,1,2,2 | 0.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 2,n=1,1,0,1,2 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 8,n=2,1,1,2,1 | -0.050 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 4,n=2,1,1,2,2 | -0.050 Millimoles per liter | Standard Deviation 0.1414 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 2,n=1,1,0,1,2 | -1.0 Millimoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Phosphate,Week 2,n=1,1,0,1,2 | 0.000 Millimoles per liter | Standard Deviation 0.0707 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 4,n=2,1,1,2,2 | -3.5 Millimoles per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 8,n=2,1,1,2,1 | 0.10 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Potassium,Week 4,n=2,1,1,2,2 | 0.00 Millimoles per liter | Standard Deviation 0.141 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 8,n=2,1,1,2,1 | 0.020 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Carbon Dioxide,Week 8,n=2,1,1,2,1 | -1.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 4,n=2,1,1,2,2 | 0.000 Millimoles per liter | Standard Deviation 0.0566 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Calcium,Week 2,n=1,1,0,1,2 | 0.040 Millimoles per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Chloride,Week 4,n=2,1,1,2,2 | 1.5 Millimoles per liter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 4,n=2,1,1,2,2 | -0.05 Millimoles per liter | Standard Deviation 0.212 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 2,n=1,1,0,1,2 | 1.25 Millimoles per liter | Standard Deviation 1.202 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 8,n=2,1,1,2,1 | 2.0 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Glucose,Week 8,n=2,1,1,2,1 | 0.20 Millimoles per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Sodium,Week 2,n=1,1,0,1,2 | 1.0 Millimoles per liter | Standard Deviation 0 |
Secondary
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Population: ITT-Part B Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,2,1,2 | -0.30 mg/L | Standard Deviation 0.361 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,2,0,2 | -0.05 mg/L | Standard Deviation 0.778 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | -0.90 mg/L | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 36, n=0,1,0,0,0 | 0.00 mg/L | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | 0.00 mg/L | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 24, n=0,1,0,0,0 | 0.00 mg/L | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,2,0,2 | 0.00 mg/L | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,2,1,2 | -0.23 mg/L | Standard Deviation 0.252 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 16, n=0,1,1,1,0 | 0.00 mg/L | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,2,1,2 | 0.05 mg/L | Standard Deviation 0.071 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,2,0,2 | 0.00 mg/L | Standard Deviation 0 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | 0.00 mg/L | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 16, n=0,1,1,1,0 | 0.00 mg/L | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,2,1,2 | 6.10 mg/L | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 16, n=0,1,1,1,0 | -0.70 mg/L | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | -0.80 mg/L | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | 0.70 mg/L | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,2,0,2 | 0.95 mg/L | Standard Deviation 0.636 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,2,1,2 | -0.55 mg/L | Standard Deviation 1.202 |
Secondary
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: ITT-Part B Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,2 | 0.00 Milligram per liter (mg/L) | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | 0.10 Milligram per liter (mg/L) | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,1,2,1 | 0.10 Milligram per liter (mg/L) | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 0.10 Milligram per liter (mg/L) | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 16, n=2,0,0,1,0 | 0.40 Milligram per liter (mg/L) | Standard Deviation 0.424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 24, n=2,0,0,0,0 | 1.90 Milligram per liter (mg/L) | Standard Deviation 2.546 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 36, n=2,0,0,0,0 | 0.80 Milligram per liter (mg/L) | Standard Deviation 0.849 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 38, n=1,0,0,0,0 | -0.10 Milligram per liter (mg/L) | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 40, n=1,0,0,0,0 | 0.00 Milligram per liter (mg/L) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | 0.10 Milligram per liter (mg/L) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,2 | -0.20 Milligram per liter (mg/L) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,1,2,1 | -0.10 Milligram per liter (mg/L) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | -0.10 Milligram per liter (mg/L) | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | 0.10 Milligram per liter (mg/L) | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,1,2,1 | 0.30 Milligram per liter (mg/L) | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 0.10 Milligram per liter (mg/L) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 14, n=0,0,0,1,0 | -30.20 Milligram per liter (mg/L) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,1,2,1 | 0.55 Milligram per liter (mg/L) | Standard Deviation 6.01 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 16, n=2,0,0,1,0 | -30.70 Milligram per liter (mg/L) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,2 | -3.70 Milligram per liter (mg/L) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 3.90 Milligram per liter (mg/L) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | -2.35 Milligram per liter (mg/L) | Standard Deviation 1.909 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,1,2,1 | -2.10 Milligram per liter (mg/L) | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | -4.20 Milligram per liter (mg/L) | Standard Deviation 2.828 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,2 | -4.20 Milligram per liter (mg/L) | Standard Deviation 2.97 |
Secondary
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17,Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30 | -0.248 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113 | 0.000 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65 | 0.163 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29 | 0.000 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85 | -0.015 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 29 | 0.233 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12 | 0.000 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12 | 0.163 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17,Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57 | 0.000 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29 | 0.212 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64 | -0.016 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373 | 0.163 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17,Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12 | -0.069 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163 | 0.042 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85 | -0.059 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59 | 0.000 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57 | 0.000 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17,Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169 | 0.232 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85 | -0.042 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day 112 | 0.163 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17,Week 12 | 0.163 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
Secondary
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | 0.041 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | -0.098 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | 0.204 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | 0.110 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | -0.127 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | -0.070 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | 0.000 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | 0.097 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | 0.000 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | 0.028 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | 0.028 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | 0.012 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | 0.000 Scores on scale |
Secondary
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | 2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | 20 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | -2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | -47 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | 8 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | -2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | 4 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | -10 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | -12 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | -8 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | 10 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 169 | 62 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | -42 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 112 | 7 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 85 | -4 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 12 | 9 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
Secondary
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | 8 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | 14 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | -12 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | -4 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | 20 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | -15 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | 9 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | 21 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | 4 Scores on scale |
Secondary
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Population: Safety-Part B Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,3,1,2 | -1.7 mm/h | Standard Deviation 5.03 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,3,0,2 | -1.0 mm/h | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | -6.0 mm/h | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 36, n=0,1,0,0,0 | 1.0 mm/h | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | 1.0 mm/h | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 24, n=0,1,0,0,0 | 1.0 mm/h | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,3,0,2 | 2.0 mm/h | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,3,1,2 | 1.3 mm/h | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 16, n=0,1,1,1,0 | 3.0 mm/h | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,3,1,2 | -1.0 mm/h | Standard Deviation 1 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,3,0,2 | -2.0 mm/h | Standard Deviation 0 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | 0.0 mm/h | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 16, n=0,1,1,1,0 | 1.0 mm/h | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,3,1,2 | 8.0 mm/h | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 16, n=0,1,1,1,0 | -4.0 mm/h | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | -6.0 mm/h | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 12, n=1,1,1,1,1 | 12.0 mm/h | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 8, n=2,1,3,0,2 | 0.0 mm/h | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Week 4, n=3,3,3,1,2 | -2.0 mm/h | Standard Deviation 5.66 |
Secondary
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,1 | -1.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | 0.5 Millimeter per hour (mm/h) | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,0,2,1 | 3.0 Millimeter per hour (mm/h) | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 0.0 Millimeter per hour (mm/h) | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 16, n=2,0,0,1,0 | -0.5 Millimeter per hour (mm/h) | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 24, n=2,0,0,0,0 | -1.5 Millimeter per hour (mm/h) | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 36, n=2,0,0,0,0 | 6.0 Millimeter per hour (mm/h) | Standard Deviation 11.31 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 38, n=1,0,0,0,0 | -1.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 40, n=1,0,0,0,0 | 1.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,1 | 4.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | 4.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,0,2,1 | 2.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 2.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 4.0 Millimeter per hour (mm/h) | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | 4.0 Millimeter per hour (mm/h) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 14, n=0,0,0,1,0 | -19.0 Millimeter per hour (mm/h) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,0,2,1 | -6.0 Millimeter per hour (mm/h) | Standard Deviation 15.56 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 16, n=2,0,0,1,0 | -18.0 Millimeter per hour (mm/h) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,1 | -14.0 Millimeter per hour (mm/h) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 12, n=2,1,1,1,0 | 10.0 Millimeter per hour (mm/h) | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | -5.0 Millimeter per hour (mm/h) | Standard Deviation 16.97 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 8, n=2,1,0,2,1 | -7.0 Millimeter per hour (mm/h) | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 4, n=2,1,1,2,2 | -29.5 Millimeter per hour (mm/h) | Standard Deviation 31.82 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Week 2, n=1,1,0,1,1 | -7.0 Millimeter per hour (mm/h) | — |
Secondary
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time frame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day112, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 23, I Feel Fatigued | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | 2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113, I Feel Fatigued | -16 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29, I Feel Fatigued | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Week 8, I Feel Fatigued | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85, I Feel Fatigued | -3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65, I Feel Fatigued | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30, I Feel Fatigued | -3 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12, I Feel Fatigued | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373, I Feel Fatigued | 5 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57, I Feel Fatigued | 13 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Week 8, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64, I Feel Fatigued | -3 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29, I Feel Fatigued | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 23, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day112, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 23, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Week 8, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12, I Feel Fatigued | 5 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163, I Feel Fatigued | 6 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85, I Feel Fatigued | -1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59, I Feel Fatigued | 7 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day112, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day112, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Week 8, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57, I Feel Fatigued | -11 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169, I Feel Fatigued | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 23, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 2, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 14, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 6, Day 65, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Week 12, I Feel Fatigued | 6 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 9, Day 29, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 11, Day 163, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 16, Day 169, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 3, Day 23, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 7, Day 373, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 12, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 5, Week 8, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 18, Day 85, I Feel Fatigued | -1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 17, Day112, I Feel Fatigued | 6 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 10, Day 57, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 13, Day 59, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 4, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 8, Day 64, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B | Par 1, Day 30, I Feel Fatigued | NA Scores on scale |
Secondary
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, I Feel Fatigued | 2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, I Feel Fatigued | -4 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, I Feel Fatigued | 8 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, I Feel Fatigued | 6 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, I Feel Fatigued | -3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, I Feel Fatigued | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, I Feel Fatigued | 2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | 2 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, I Feel Fatigued | -12 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, I Feel Fatigued | -4 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, I Feel Fatigued | -5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87, I Feel Fatigued | -10 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, I Feel Fatigued | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85, I Feel Fatigued | -7 Scores on scale |
Secondary
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -0.03 Trillion cells per liter | Standard Deviation 0.252 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.15 Trillion cells per liter | Standard Deviation 0.495 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -0.10 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 36,n=0,1,0,0,0 | 0.10 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.10 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 24,n=0,1,0,0,0 | 0.00 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 0.00 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -0.10 Trillion cells per liter | Standard Deviation 0.173 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 0.10 Trillion cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 0.10 Trillion cells per liter | Standard Deviation 0.283 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 0.10 Trillion cells per liter | Standard Deviation 0.283 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.60 Trillion cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 0.70 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 0.10 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | -0.10 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.00 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -0.10 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.20 Trillion cells per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -0.20 Trillion cells per liter | Standard Deviation 0 |
Secondary
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.00 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.00 Trillion cells per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.10 Trillion cells per liter | Standard Deviation 0.141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.10 Trillion cells per liter | Standard Deviation 0.141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | 0.00 Trillion cells per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 24,n=2,0,0,0,0 | 0.00 Trillion cells per liter | Standard Deviation 0.283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 36,n=2,0,0,0,0 | -0.05 Trillion cells per liter | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 38,n=1,0,0,0,0 | 0.00 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 40,n=1,0,0,0,0 | 0.00 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -0.10 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | -0.10 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.00 Trillion cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | NA Trillion cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -0.30 Trillion cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.00 Trillion cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.00 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 14,n=0,0,0,1,0 | 0.10 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.05 Trillion cells per liter | Standard Deviation 0.212 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | -0.20 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.30 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | -0.20 Trillion cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.00 Trillion cells per liter | Standard Deviation 0.283 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.15 Trillion cells per liter | Standard Deviation 0.071 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.10 Trillion cells per liter | Standard Deviation 0.141 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.25 Trillion cells per liter | Standard Deviation 0.071 |
Secondary
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -0.33 Picograms | Standard Deviation 0.757 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.15 Picograms | Standard Deviation 0.354 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -0.10 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 36,n=0,1,0,0,0 | -0.20 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -0.50 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 24,n=0,1,0,0,0 | -0.80 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.60 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -0.47 Picograms | Standard Deviation 0.451 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | -0.80 Picograms | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -0.25 Picograms | Standard Deviation 0.354 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 0.00 Picograms | Standard Deviation 1.273 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.70 Picograms | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | -0.20 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -1.00 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 1.30 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 2.20 Picograms | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 1.80 Picograms | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 1.10 Picograms | Standard Deviation 2.121 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 0.00 Picograms | Standard Deviation 0.849 |
Secondary
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | -1.10 Picograms | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.30 Picograms | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.30 Picograms | Standard Deviation 0.424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.25 Picograms | Standard Deviation 0.212 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | 0.00 Picograms | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 24,n=2,0,0,0,0 | 0.10 Picograms | Standard Deviation 0.141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 36,n=2,0,0,0,0 | 0.25 Picograms | Standard Deviation 0.354 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 38,n=1,0,0,0,0 | -0.40 Picograms | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 40,n=1,0,0,0,0 | 0.40 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.60 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.20 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 1.30 Picograms | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | NA Picograms | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.20 Picograms | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.30 Picograms | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.30 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 14,n=0,0,0,1,0 | -0.90 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | -0.45 Picograms | Standard Deviation 0.919 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | -0.10 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | -0.20 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.00 Picograms | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -0.05 Picograms | Standard Deviation 0.354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,2 | 0.70 Picograms | Standard Deviation 0.141 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 1.00 Picograms | Standard Deviation 1.273 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.60 Picograms | Standard Deviation 0.99 |
Secondary
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.5 Femtoliter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 0.7 Femtoliter | Standard Deviation 1.15 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 36,n=0,1,0,0,0 | 4.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 1.3 Femtoliter | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 1.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 2.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 1.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 24,n=0,1,0,0,0 | 3.0 Femtoliter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 0.0 Femtoliter | Standard Deviation 0 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -1.0 Femtoliter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 0.0 Femtoliter | Standard Deviation 1.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 0.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 2.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | -3.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 1.0 Femtoliter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 2.0 Femtoliter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 1.5 Femtoliter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,2,1,2 | 2.0 Femtoliter | Standard Deviation 1.41 |
Secondary
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 1.5 Femtoliter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 1.5 Femtoliter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 38,n=1,0,0,0,0 | 0.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | 0.5 Femtoliter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | -2.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 24,n=2,0,0,0,0 | 1.5 Femtoliter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,0,1,1,0 | 2.5 Femtoliter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 36,n=2,0,0,0,0 | 2.5 Femtoliter | Standard Deviation 2.12 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 40,n=1,0,0,0,0 | -2.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 1.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 1.0 Femtoliter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -1.0 Femtoliter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 0.0 Femtoliter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,0,1,1,0 | 0.0 Femtoliter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 1.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -2.5 Femtoliter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -1.5 Femtoliter | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,0,1,1,0 | -6.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 14,n=0,0,0,1,0 | -5.0 Femtoliter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | -4.0 Femtoliter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 2.0 Femtoliter | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.5 Femtoliter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.5 Femtoliter | Standard Deviation 2.12 |
Secondary
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 4,n=3,3,2,1,2 | -0.0047 Proportion of red blood cells in blood | Standard Deviation 0.0257 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,2,0,2 | -0.0185 Proportion of red blood cells in blood | Standard Deviation 0.04879 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 12,n=1,1,1,1,1 | -0.0120 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 36,n=0,1,0,0,0 | 0.0280 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 12,n=1,1,1,1,1 | 0.0080 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 24,n=0,1,0,0,0 | 0.0100 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,2,0,2 | 0.0000 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 4,n=3,3,2,1,2 | -0.0057 Proportion of red blood cells in blood | Standard Deviation 0.01834 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 16,n=0,1,1,1,0 | 0.0060 Proportion of red blood cells in blood | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 4,n=3,3,2,1,2 | 0.0115 Proportion of red blood cells in blood | Standard Deviation 0.02616 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,2,0,2 | 0.0135 Proportion of red blood cells in blood | Standard Deviation 0.01768 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 12,n=1,1,1,1,1 | 0.0470 Proportion of red blood cells in blood | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 16,n=0,1,1,1,0 | 0.0610 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 4,n=3,3,2,1,2 | -0.0040 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 16,n=0,1,1,1,0 | -0.0030 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 12,n=1,1,1,1,1 | -0.0010 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 12,n=1,1,1,1,1 | 0.0030 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,2,0,2 | -0.0120 Proportion of red blood cells in blood | Standard Deviation 0.00424 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hematocrit,Week 4,n=3,3,2,1,2 | -0.0070 Proportion of red blood cells in blood | Standard Deviation 0.00849 |
Secondary
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 2,n=1,1,0,1,2 | -0.0080 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 4,n=2,1,1,2,2 | 0.0030 Proportion of red blood cells in blood | Standard Deviation 0.00141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,1,2,2 | 0.0115 Proportion of red blood cells in blood | Standard Deviation 0.01909 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 12,n=2,0,1,1,0 | 0.0125 Proportion of red blood cells in blood | Standard Deviation 0.01202 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 16,n=2,0,0,1,0 | 0.0000 Proportion of red blood cells in blood | Standard Deviation 0.00141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 24,n=2,0,0,0,0 | 0.0040 Proportion of red blood cells in blood | Standard Deviation 0.02687 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 36,n=2,0,0,0,0 | 0.0005 Proportion of red blood cells in blood | Standard Deviation 0.01626 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 38,n=1,0,0,0,0 | -0.0050 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 40,n=1,0,0,0,0 | -0.0140 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 2,n=1,1,0,1,2 | -0.0060 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,1,2,2 | -0.0110 Proportion of red blood cells in blood | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 4,n=2,1,1,2,2 | -0.0080 Proportion of red blood cells in blood | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 12,n=2,0,1,1,0 | -0.0060 Proportion of red blood cells in blood | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 4,n=2,1,1,2,2 | -0.0250 Proportion of red blood cells in blood | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,1,2,2 | -0.0030 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 14,n=0,0,0,1,0 | -0.0080 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,1,2,2 | -0.0040 Proportion of red blood cells in blood | Standard Deviation 0.01414 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 16,n=2,0,0,1,0 | 0.0080 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 2,n=1,1,0,1,2 | 0.0250 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 12,n=2,0,1,1,0 | -0.0420 Proportion of red blood cells in blood | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 4,n=2,1,1,2,2 | -0.0060 Proportion of red blood cells in blood | Standard Deviation 0.03111 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 8,n=2,1,1,2,2 | 0.0260 Proportion of red blood cells in blood | Standard Deviation 0.02546 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 4,n=2,1,1,2,2 | 0.0105 Proportion of red blood cells in blood | Standard Deviation 0.00354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hematocrit,Week 2,n=1,1,0,1,2 | 0.0235 Proportion of red blood cells in blood | Standard Deviation 0.01202 |
Secondary
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,2,0,2 | -0.205 Giga cells per liter | Standard Deviation 0.1909 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,2,0,2 | -0.070 Giga cells per liter | Standard Deviation 0.0707 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 4,n=3,3,2,1,2 | 0.40 Giga cells per liter | Standard Deviation 0.5 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 12,n=1,1,1,1,1 | 27.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 8,n=2,1,2,0,2 | 17.5 Giga cells per liter | Standard Deviation 23.33 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 12,n=1,1,1,1,1 | -0.120 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 4,n=3,3,2,1,2 | 15.0 Giga cells per liter | Standard Deviation 31.43 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,2,0,2 | 0.25 Giga cells per liter | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 12,n=1,1,1,1,1 | -0.210 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 4,n=3,3,2,1,2 | 0.293 Giga cells per liter | Standard Deviation 0.2136 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 4,n=3,3,2,1,2 | 0.183 Giga cells per liter | Standard Deviation 0.4196 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 4,n=3,3,2,1,2 | -0.110 Giga cells per liter | Standard Deviation 0.1735 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 12,n=1,1,1,1,1 | -0.750 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 12,n=1,1,1,1,1 | -1.30 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,2,0,2 | 0.470 Giga cells per liter | Standard Deviation 0.0707 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 4,n=3,3,2,1,2 | -6.0 Giga cells per liter | Standard Deviation 9.64 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,2,0,2 | 0.10 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,2,0,2 | 0.090 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 36,n=0,1,0,0,0 | -0.420 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 12,n=1,1,1,1,1 | -1.60 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 24,n=0,1,0,0,0 | -0.350 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 16,n=0,1,1,1,0 | -0.220 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 16,n=0,1,1,1,0 | -0.50 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,2,0,2 | 0.020 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 12,n=1,1,1,1,1 | -1.440 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 24,n=0,1,0,0,0 | -0.60 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 36,n=0,1,0,0,0 | -1.10 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 4,n=3,3,2,1,2 | 0.077 Giga cells per liter | Standard Deviation 0.2442 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 4,n=3,3,2,1,2 | -0.013 Giga cells per liter | Standard Deviation 0.0551 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,2,0,2 | 0.010 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 24,n=0,1,0,0,0 | -20.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 16,n=0,1,1,1,0 | -4.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 12,n=1,1,1,1,1 | 0.140 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 4,n=3,3,2,1,2 | 0.333 Giga cells per liter | Standard Deviation 1.0108 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 16,n=0,1,1,1,0 | -0.040 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 12,n=1,1,1,1,1 | -0.120 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 36,n=0,1,0,0,0 | -0.240 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 24,n=0,1,0,0,0 | 0.000 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 12,n=1,1,1,1,1 | -20.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 16,n=0,1,1,1,0 | -0.200 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 36,n=0,1,0,0,0 | -16.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 8,n=2,1,2,0,2 | -25.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 24,n=0,1,0,0,0 | -0.100 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 36,n=0,1,0,0,0 | -0.240 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 4,n=3,3,2,1,2 | 0.30 Giga cells per liter | Standard Deviation 1.229 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 4,n=3,3,2,1,2 | 0.50 Giga cells per liter | Standard Deviation 0 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 4,n=3,3,2,1,2 | -0.050 Giga cells per liter | Standard Deviation 0.0849 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,2,0,2 | 0.020 Giga cells per liter | Standard Deviation 0.2546 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 12,n=1,1,1,1,1 | -0.190 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 16,n=0,1,1,1,0 | -0.180 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,2,0,2 | 0.90 Giga cells per liter | Standard Deviation 0.424 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 12,n=1,1,1,1,1 | 0.80 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 16,n=0,1,1,1,0 | 0.30 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 4,n=3,3,2,1,2 | 0.370 Giga cells per liter | Standard Deviation 0.099 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,2,0,2 | 0.205 Giga cells per liter | Standard Deviation 0.0495 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 12,n=1,1,1,1,1 | 0.190 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 16,n=0,1,1,1,0 | 0.340 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 4,n=3,3,2,1,2 | 0.180 Giga cells per liter | Standard Deviation 0.1414 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,2,0,2 | 0.600 Giga cells per liter | Standard Deviation 0.0283 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 12,n=1,1,1,1,1 | 0.820 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 16,n=0,1,1,1,0 | 0.230 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 4,n=3,3,2,1,2 | 10.5 Giga cells per liter | Standard Deviation 3.54 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 8,n=2,1,2,0,2 | 10.0 Giga cells per liter | Standard Deviation 22.63 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 12,n=1,1,1,1,1 | 14.0 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 16,n=0,1,1,1,0 | 15.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 12,n=1,1,1,1,1 | -1.770 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 16,n=0,1,1,1,0 | -0.210 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 16,n=0,1,1,1,0 | -0.050 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 16,n=0,1,1,1,0 | -19.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 12,n=1,1,1,1,1 | -1.50 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 16,n=0,1,1,1,0 | -1.30 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 12,n=1,1,1,1,1 | 0.070 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 16,n=0,1,1,1,0 | -0.520 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 4,n=3,3,2,1,2 | -0.960 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 12,n=1,1,1,1,1 | 0.380 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 4,n=3,3,2,1,2 | -0.40 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 4,n=3,3,2,1,2 | 0.390 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 4,n=3,3,2,1,2 | -0.030 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 4,n=3,3,2,1,2 | 26.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 12,n=1,1,1,1,1 | -8.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 4,n=3,3,2,1,2 | -14.0 Giga cells per liter | Standard Deviation 4.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 12,n=1,1,1,1,1 | 14.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 12,n=1,1,1,1,1 | -0.140 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 12,n=1,1,1,1,1 | -0.70 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,2,0,2 | 0.330 Giga cells per liter | Standard Deviation 0.4101 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,2,0,2 | 0.65 Giga cells per liter | Standard Deviation 0.071 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Leukocytes,Week 4,n=3,3,2,1,2 | 1.30 Giga cells per liter | Standard Deviation 0.99 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,2,0,2 | 0.500 Giga cells per liter | Standard Deviation 0.8627 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Neutrophils ,Week 4,n=3,3,2,1,2 | 0.815 Giga cells per liter | Standard Deviation 0.0212 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Platelets,Week 8,n=2,1,2,0,2 | 31.5 Giga cells per liter | Standard Deviation 4.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 12,n=1,1,1,1,1 | 0.030 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 12,n=1,1,1,1,1 | -0.610 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Eosinophils,Week 4,n=3,3,2,1,2 | 0.415 Giga cells per liter | Standard Deviation 0.5869 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,2,0,2 | -0.180 Giga cells per liter | Standard Deviation 0.4243 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Lymphocytes,Week 4,n=3,3,2,1,2 | 0.015 Giga cells per liter | Standard Deviation 0.2475 |
Secondary
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 16,n=2,0,0,1,0 | 0.030 Giga cells per liter | Standard Deviation 0.0141 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 4,n=2,1,1,2,2 | 0.205 Giga cells per liter | Standard Deviation 0.5728 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 4,n=2,1,1,2,2 | -1.0 Giga cells per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 2,n=1,1,0,1,2 | -0.20 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 24,n=2,0,0,0,0 | -18.5 Giga cells per liter | Standard Deviation 9.19 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 4,n=2,1,1,2,2 | 0.25 Giga cells per liter | Standard Deviation 0.778 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 16,n=2,0,0,1,0 | 2.0 Giga cells per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,1,2,1 | -0.25 Giga cells per liter | Standard Deviation 1.061 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 38,n=1,0,0,0,0 | -15.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 12,n=2,0,1,1,0 | -0.10 Giga cells per liter | Standard Deviation 0.99 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,1,2,1 | -0.010 Giga cells per liter | Standard Deviation 0.0424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 16,n=2,0,0,1,0 | -0.45 Giga cells per liter | Standard Deviation 0.778 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 24,n=2,0,0,0,0 | -0.20 Giga cells per liter | Standard Deviation 0.424 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 36,n=2,0,0,0,0 | 0.65 Giga cells per liter | Standard Deviation 0.354 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 38,n=1,0,0,0,0 | -0.50 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 40,n=1,0,0,0,0 | -1.30 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 2,n=1,1,0,1,2 | -0.170 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 2,n=1,1,0,1,2 | -0.010 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 4,n=2,1,1,2,2 | 0.110 Giga cells per liter | Standard Deviation 0.0566 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 36,n=2,0,0,0,0 | 10.0 Giga cells per liter | Standard Deviation 21.21 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 12,n=2,0,1,1,0 | 7.0 Giga cells per liter | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,1,2,1 | -0.120 Giga cells per liter | Standard Deviation 0.0283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 12,n=2,0,1,1,0 | -0.030 Giga cells per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 12,n=2,0,1,1,0 | -0.030 Giga cells per liter | Standard Deviation 0.0283 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 40,n=1,0,0,0,0 | -6.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 16,n=2,0,0,1,0 | -0.230 Giga cells per liter | Standard Deviation 0.2828 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 4,n=2,1,1,2,2 | -0.015 Giga cells per liter | Standard Deviation 0.0212 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 24,n=2,0,0,0,0 | -0.320 Giga cells per liter | Standard Deviation 0.1697 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 36,n=2,0,0,0,0 | 0.195 Giga cells per liter | Standard Deviation 0.1768 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | LymphocytesWeek 38,n=1,0,0,0,0 | 0.010 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 40,n=1,0,0,0,0 | -0.160 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 2,n=1,1,0,1,2 | -0.040 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 8,n=2,1,1,2,1 | 7.0 Giga cells per liter | Standard Deviation 11.31 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,1,2,2 | -0.265 Giga cells per liter | Standard Deviation 0.6435 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 24,n=2,0,0,0,0 | -0.015 Giga cells per liter | Standard Deviation 0.0212 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 12,n=2,0,1,1,0 | 0.020 Giga cells per liter | Standard Deviation 0.8061 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 36,n=2,0,0,0,0 | -0.010 Giga cells per liter | Standard Deviation 0.0566 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 16,n=2,0,0,1,0 | -0.235 Giga cells per liter | Standard Deviation 0.4879 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 38,n=1,0,0,0,0 | 0.020 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 24,n=2,0,0,0,0 | 0.085 Giga cells per liter | Standard Deviation 0.6859 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 36,n=2,0,0,0,0 | 0.540 Giga cells per liter | Standard Deviation 0.6788 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 38,n=1,0,0,0,0 | -0.460 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils,Week 40,n=1,0,0,0,0 | -0.770 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets ,Week 2,n=1,1,0,1,2 | 5.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 40,n=1,0,0,0,0 | -0.030 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 4,n=2,1,1,2,2 | -0.210 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,1,2,1 | 0.00 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 4,n=2,1,1,2,2 | -0.340 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,1,2,1 | -0.180 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,1,2,2 | 0.060 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets ,Week 2,n=1,1,0,1,2 | 4.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 2,n=1,1,0,1,2 | -0.110 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 8,n=2,1,1,2,1 | -6.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 4,n=2,1,1,2,2 | 6.0 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 2,n=1,1,0,1,2 | 0.30 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 2,n=1,1,0,1,2 | 0.510 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 2,n=1,1,0,1,2 | 0.000 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,1,2,1 | 0.160 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 4,n=2,1,1,2,2 | -0.30 Giga cells per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 4,n=2,1,1,2,2 | 0.400 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 4,n=2,1,1,2,2 | 0.20 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 4,n=2,1,1,2,2 | 0.230 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,1,2,1 | 0.050 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,1,2,2 | 0.620 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 4,n=2,1,1,2,2 | -1.0 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 12,n=2,0,1,1,0 | 0.630 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,1,2,1 | 0.60 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 12,n=2,0,1,1,0 | 52.0 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 8,n=2,1,1,2,1 | 2.0 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 12,n=2,0,1,1,0 | 0.90 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 4,n=2,1,1,2,2 | -0.010 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,1,2,1 | 0.040 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 12,n=2,0,1,1,0 | 0.300 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 4,n=2,1,1,2,2 | -0.010 Giga cells per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 12,n=2,0,1,1,0 | 0.030 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 14,n=0,0,0,1,0 | 0.590 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 2,n=1,1,0,1,2 | 0.000 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 4,n=2,1,1,2,2 | -0.030 Giga cells per liter | Standard Deviation 0.0283 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,1,2,1 | -0.120 Giga cells per liter | Standard Deviation 0.1838 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 12,n=2,0,1,1,0 | -0.160 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 14,n=0,0,0,1,0 | -0.290 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 16,n=2,0,0,1,0 | -0.270 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 2,n=1,1,0,1,2 | 2.60 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 4,n=2,1,1,2,2 | 0.60 Giga cells per liter | Standard Deviation 1.697 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,1,2,1 | 0.10 Giga cells per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 12,n=2,0,1,1,0 | -0.60 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 14,n=0,0,0,1,0 | 0.40 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 16,n=2,0,0,1,0 | -0.30 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 2,n=1,1,0,1,2 | -0.400 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 4,n=2,1,1,2,2 | -0.035 Giga cells per liter | Standard Deviation 0.2051 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,1,2,1 | -0.185 Giga cells per liter | Standard Deviation 0.3323 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 12,n=2,0,1,1,0 | -0.190 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 14,n=0,0,0,1,0 | 0.490 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 16,n=2,0,0,1,0 | 0.540 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 2,n=1,1,0,1,2 | 3.010 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 4,n=2,1,1,2,2 | 0.740 Giga cells per liter | Standard Deviation 1.895 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,1,2,2 | 0.485 Giga cells per liter | Standard Deviation 0.1909 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 12,n=2,0,1,1,0 | -0.320 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 16,n=2,0,0,1,0 | -0.050 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets ,Week 2,n=1,1,0,1,2 | -27.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 4,n=2,1,1,2,2 | -33.5 Giga cells per liter | Standard Deviation 30.41 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 8,n=2,1,1,2,1 | -20.5 Giga cells per liter | Standard Deviation 28.99 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 12,n=2,0,1,1,0 | 12.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 14,n=0,0,0,1,0 | -31.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 16,n=2,0,0,1,0 | -97.0 Giga cells per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 4,n=2,1,1,2,2 | -1.420 Giga cells per liter | Standard Deviation 0.495 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 2,n=1,1,0,1,2 | -2.210 Giga cells per liter | Standard Deviation 0.5233 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 8,n=2,1,1,2,1 | -0.275 Giga cells per liter | Standard Deviation 0.4172 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 2,n=1,1,0,1,2 | -2.30 Giga cells per liter | Standard Deviation 0.424 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 8,n=2,1,1,2,1 | -40.0 Giga cells per liter | Standard Deviation 0 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 4,n=2,1,1,2,2 | -0.115 Giga cells per liter | Standard Deviation 0.5162 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 8,n=2,1,1,2,1 | -0.95 Giga cells per liter | Standard Deviation 2.333 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 8,n=2,1,1,2,1 | 0.045 Giga cells per liter | Standard Deviation 0.0636 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 4,n=2,1,1,2,2 | 0.035 Giga cells per liter | Standard Deviation 0.0495 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Leukocytes,Week 4,n=2,1,1,2,2 | -1.45 Giga cells per liter | Standard Deviation 0.071 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets ,Week 2,n=1,1,0,1,2 | -20.5 Giga cells per liter | Standard Deviation 57.28 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Lymphocytes,Week 2,n=1,1,0,1,2 | -0.160 Giga cells per liter | Standard Deviation 0.099 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Neutrophils ,Week 8,n=2,1,1,2,2 | -0.790 Giga cells per liter | Standard Deviation 1.8385 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Eosinophils,Week 2,n=1,1,0,1,2 | -0.010 Giga cells per liter | Standard Deviation 0.0141 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Platelets,Week 4,n=2,1,1,2,2 | -42.0 Giga cells per liter | Standard Deviation 11.31 |
Secondary
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,2,0,2 | -6.0 Grams per liter | Standard Deviation 14.14 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 4,n=3,3,2,1,2 | -18.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 4,n=3,3,2,1,2 | -4.0 Grams per liter | Standard Deviation 5.29 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 12,n=1,1,1,1,1 | -5.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 36,n=0,1,0,0,0 | 2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 4,n=3,3,2,1,2 | -14.0 Grams per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 8,n=0,1,2,0,2 | -8.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 12,n=0,1,1,1,1 | -10.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 16,n=0,1,1,1,0 | -9.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 24,n=0,1,0,0,0 | -17.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 36,n=0,1,0,0,0 | -15.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 4,n=3,3,2,1,2 | -6.3 Grams per liter | Standard Deviation 3.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,2,0,2 | -4.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 12,n=1,1,1,1,1 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 16,n=0,1,1,1,0 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 24,n=0,1,0,0,0 | -4.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,2,0,2 | 4.0 Grams per liter | Standard Deviation 12.73 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 12,n=0,1,1,1,1 | 11.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 4,n=3,3,2,1,2 | -3.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 4,n=3,3,2,1,2 | 2.0 Grams per liter | Standard Deviation 9.9 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 8,n=0,1,2,0,2 | -0.5 Grams per liter | Standard Deviation 16.26 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 16,n=0,1,1,1,0 | -1.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 12,n=1,1,1,1,1 | 20.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 16,n=0,1,1,1,0 | 19.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 12,n=1,1,1,1,1 | 8.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 4,n=3,3,2,1,2 | -2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 4,n=3,3,2,1,2 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 16,n=0,1,1,1,0 | 2.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 12,n=0,1,1,1,1 | 21.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 16,n=0,1,1,1,0 | 8.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 12,n=1,1,1,1,1 | 5.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 12,n=0,1,1,1,1 | 11.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 4,n=3,3,2,1,2 | -7.0 Grams per liter | Standard Deviation 11.31 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | MCHC,Week 8,n=0,1,2,0,2 | 8.0 Grams per liter | Standard Deviation 19.8 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 4,n=3,3,2,1,2 | -5.5 Grams per liter | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,2,0,2 | -1.5 Grams per liter | Standard Deviation 10.61 |
Secondary
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 24,n=2,0,0,0,0 | -3.0 Grams per liter | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 36,n=2,0,0,0,0 | -4.0 Grams per liter | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 38,n=1,0,0,0,0 | -3.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 40,n=1,0,0,0,0 | 4.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 38,n=1,0,0,0,0 | -3.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 36,n=2,0,0,0,0 | -1.5 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 2,n=1,1,0,1,1 | -3.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 24,n=2,0,0,0,0 | -0.5 Grams per liter | Standard Deviation 7.78 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 16,n=2,0,0,1,0 | 0.0 Grams per liter | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 8,n=2,1,0,2,1 | 0.0 Grams per liter | Standard Deviation 12.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 40,n=1,0,0,0,0 | -3.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 12,n=2,0,1,1,0 | 1.5 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,1,2,1 | 4.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 12,n=2,0,0,1,0 | -5.5 Grams per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 4,n=2,1,0,2,1 | -1.5 Grams per liter | Standard Deviation 3.54 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 4,n=2,1,1,2,2 | 0.5 Grams per liter | Standard Deviation 0.71 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 16,n=2,0,0,1,0 | 0.0 Grams per liter | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 2,n=1,1,0,1,2 | -4.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 4,n=2,1,1,2,2 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 2,n=1,1,0,1,1 | -1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 4,n=2,1,0,2,1 | 1.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 8,n=2,1,0,2,1 | 16.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 2,n=1,1,0,1,2 | -2.0 Grams per liter | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,1,2,1 | 3.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 4,n=2,1,1,2,2 | -9.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 12,n=2,0,1,1,0 | 0.0 Grams per liter | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,1,2,1 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 4,n=2,1,1,2,2 | -0.5 Grams per liter | Standard Deviation 10.61 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 2,n=1,1,0,1,1 | -3.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 14,n=0,0,0,1,0 | 5.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 12,n=2,0,0,1,0 | 19.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 12,n=2,0,1,1,0 | -6.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 14,n=0,0,0,1,0 | 0.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 16,n=2,0,0,1,0 | 8.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 4,n=2,1,0,2,1 | 3.5 Grams per liter | Standard Deviation 2.12 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 16,n=2,0,0,1,0 | 11.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 2,n=1,1,0,1,2 | 7.0 Grams per liter | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,1,2,1 | -0.5 Grams per liter | Standard Deviation 10.61 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 8,n=2,1,0,2,1 | 3.5 Grams per liter | Standard Deviation 14.85 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 8,n=2,1,0,2,1 | 9.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 8,n=2,1,1,2,1 | 9.0 Grams per liter | Standard Deviation 4.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 4,n=2,1,1,2,2 | 8.0 Grams per liter | Standard Deviation 8.49 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 4,n=2,1,0,2,1 | 23.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | MCHC,Week 2,n=1,1,0,1,1 | 20.0 Grams per liter | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Hemoglobin,Week 2,n=1,1,0,1,2 | 10.0 Grams per liter | Standard Deviation 4.24 |
Secondary
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time frame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 2, Day 29 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 8 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Day 85 | 2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 3, Day 23 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Week 4 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Day 65 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 8 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 12 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 4 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 4 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Day 113 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 1, Day 30 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 4 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 8 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 12 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Day 373 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Week 4 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Day 64 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 9, Day 29 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Week 4 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Day 57 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Day 163 | 1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Day 59 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Week 4 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Day 85 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 8 | -1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 12 | 1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 8 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 4 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 4 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Week 4 | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Day 57 | -1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 16, Day 169 | -3 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Day 112 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Day 85 | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 18, Week 8 | 1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 16, Day 169 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 4 | -2 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Week 12 | -2 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 17, Day 112 | -2 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
Secondary
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | 4 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | 4 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | -2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | -1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | -2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | -2 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | -3 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | 2 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | 1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | -2 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | 1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | -2 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | 1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | -1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | 2 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | -1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | 1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
Secondary
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time frame: Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373
Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | -0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Week 12 | 0.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | -0.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | -0.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | 0.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | 0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | 0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | -0.1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | 0.9 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | 0.9 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | 0.4 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | 0.1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | -0.1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | -0.6 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | -0.3 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | 0.3 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | -0.5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | -0.3 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | 0.4 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | 0.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | -0.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | 0.0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | 0.2 Scores on scale |
Secondary
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | -1.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | 0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 203 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | -1.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | -0.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | -0.6 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | -1.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | -0.9 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | -0.6 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | 0.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | 0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 203 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | -0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | 0.1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 203 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | -0.2 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 203 | 7.6 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | -1.1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | 1.5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | -0.7 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | -1.1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | -0.4 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | 1.8 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | 0.0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | 0.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 203 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | 0.0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | 0.0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | -6.0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | -6.3 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
Secondary
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | -1.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8 | 0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | -0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 8 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 4 | -0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | 2.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | 0.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | 1.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | 0.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | 0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | 0.9 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | -0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | -0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | 0.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | -0.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | 0.2 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 8 | 0.2 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | -0.7 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 4 | -0.1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | -0.8 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | -0.7 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | 1.2 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | 0.9 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | 1.0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | 0.3 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | -0.4 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | -0.9 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | -1.1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 59 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 65 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Week 8 | 0.2 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 23 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 30 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 169 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 57 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 64 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 12 | -0.3 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 163 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Week 4 | -0.3 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 112 | -0.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 373 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 29 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 85 | -0.1 Scores on scale |
Secondary
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | -0.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | -0.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | 0.9 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | -0.6 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | -1.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | 2.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | 0.5 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | -0.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | -0.6 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | -0.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | 4.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | 4.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | -0.3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | 4.0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | 2.2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | 0.4 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3,Par 3,, Day 113 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | -0.7 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3,Par 3,, Day 113 | 2.1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3,Par 3,, Day 113 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | -1.0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | 4.9 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | 0.4 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3,Par 3,, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | 2.0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | 0.2 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | 1.0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | 0.8 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | -3.1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | -3.2 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | -0.1 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | -3.5 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | 1.0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 2 | -0.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 38 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 2 | -0.7 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 4 | 0.7 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 87 | -3.1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 2 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 40 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 14 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 162 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Week 4 | -3.7 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 85 | -0.4 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Week 8 | 0.8 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 12 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3,Par 3,, Day 113 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Week 8 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 8 | 0.4 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 36 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 16 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 91 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 4 | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Week 4 | NA Scores on scale |
Secondary
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 1.4 beats per minute | Standard Deviation 10.11 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 8.0 beats per minute | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 11.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | 3.7 beats per minute | Standard Deviation 1.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 36,n=0,1,0,0,0 | 0.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 4.0 beats per minute | Standard Deviation 6.53 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | 0.3 beats per minute | Standard Deviation 3.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -4.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | -4.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 24,n=0,1,0,0,0 | 0.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 4.0 beats per minute | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | -4.0 beats per minute | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | -1.5 beats per minute | Standard Deviation 2.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -5.5 beats per minute | Standard Deviation 2.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 4.0 beats per minute | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | -14.7 beats per minute | Standard Deviation 2.31 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 6.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | -29.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 6.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | -7.7 beats per minute | Standard Deviation 17.62 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.5 beats per minute | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | -1.5 beats per minute | Standard Deviation 6.36 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 7.5 beats per minute | Standard Deviation 4.95 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 6.0 beats per minute | — |
Secondary
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 4.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -2.0 beats per minute | Standard Deviation 8.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 0.0 beats per minute | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | -2.0 beats per minute | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | 2.0 beats per minute | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 24,n=2,0,0,0,0 | 5.0 beats per minute | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 36,n=2,0,0,0,0 | -2.0 beats per minute | Standard Deviation 8.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 38,n=1,0,0,0,0 | 0.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 40,n=1,0,0,0,0 | 0.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | 5.0 beats per minute | Standard Deviation 12.73 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 3.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 2.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | -3.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 7.0 beats per minute | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 6.0 beats per minute | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 4.0 beats per minute | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -10.0 beats per minute | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 4.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | -14.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -17.0 beats per minute | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | -22.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | -12.0 beats per minute | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -12.5 beats per minute | Standard Deviation 9.19 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 14,n=0,0,0,1,0 | -24.0 beats per minute | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | 6.0 beats per minute | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -5.5 beats per minute | Standard Deviation 9.19 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 4.0 beats per minute | Standard Deviation 8.49 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -4.0 beats per minute | — |
Secondary
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week follow up,n=5,4,2,3,2 | -7.4 Millimeters of mercury | Standard Deviation 19.62 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 12,n=1,1,1,1,1 | -59.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week follow up,n=5,4,2,3,2 | 3.4 Millimeters of mercury | Standard Deviation 12.34 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 12,n=1,1,1,1,1 | -22.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 8,n=2,1,2,0,2 | -9.0 Millimeters of mercury | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 8,n=2,1,2,0,2 | -32.5 Millimeters of mercury | Standard Deviation 14.85 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 4,n=3,3,3,1,2 | -23.7 Millimeters of mercury | Standard Deviation 4.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 4,n=3,3,3,1,2 | -8.3 Millimeters of mercury | Standard Deviation 14.29 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 8,n=2,1,2,0,2 | -6.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 4,n=3,3,3,1,2 | -6.3 Millimeters of mercury | Standard Deviation 5.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 12,n=1,1,1,1,1 | -4.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 16,n=0,1,1,1,0 | -8.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 24,n=0,1,0,0,0 | 4.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 36,n=0,1,0,0,0 | -26.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week follow up,n=5,4,2,3,2 | -3.3 Millimeters of mercury | Standard Deviation 8.54 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 4,n=3,3,3,1,2 | 0.3 Millimeters of mercury | Standard Deviation 4.51 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 8,n=2,1,2,0,2 | -10.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 12,n=1,1,1,1,1 | -6.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 16,n=0,1,1,1,0 | 0.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 24,n=0,1,0,0,0 | -10.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 36,n=0,1,0,0,0 | -10.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week follow up,n=5,4,2,3,2 | -2.8 Millimeters of mercury | Standard Deviation 4.57 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week follow up,n=5,4,2,3,2 | -17.5 Millimeters of mercury | Standard Deviation 31.82 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 8,n=2,1,2,0,2 | -7.5 Millimeters of mercury | Standard Deviation 17.68 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week follow up,n=5,4,2,3,2 | 12.5 Millimeters of mercury | Standard Deviation 10.61 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 4,n=3,3,3,1,2 | 7.7 Millimeters of mercury | Standard Deviation 8.74 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 8,n=2,1,2,0,2 | 16.5 Millimeters of mercury | Standard Deviation 2.12 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 4,n=3,3,3,1,2 | 7.0 Millimeters of mercury | Standard Deviation 25.36 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 12,n=1,1,1,1,1 | 15.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 12,n=1,1,1,1,1 | 15.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 16,n=0,1,1,1,0 | 25.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 16,n=0,1,1,1,0 | 15.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 12,n=1,1,1,1,1 | 8.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 4,n=3,3,3,1,2 | 10.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 16,n=0,1,1,1,0 | -17.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 4,n=3,3,3,1,2 | -4.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 12,n=1,1,1,1,1 | 13.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week follow up,n=5,4,2,3,2 | 10.7 Millimeters of mercury | Standard Deviation 10.07 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week follow up,n=5,4,2,3,2 | 6.0 Millimeters of mercury | Standard Deviation 4.36 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 16,n=0,1,1,1,0 | -8.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 12,n=1,1,1,1,1 | -2.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week follow up,n=5,4,2,3,2 | -2.0 Millimeters of mercury | Standard Deviation 4.24 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 8,n=2,1,2,0,2 | -1.5 Millimeters of mercury | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week follow up,n=5,4,2,3,2 | 5.0 Millimeters of mercury | Standard Deviation 1.41 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 8,n=2,1,2,0,2 | -6.0 Millimeters of mercury | Standard Deviation 8.49 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 12,n=1,1,1,1,1 | -9.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | DBP,Week 4,n=3,3,3,1,2 | -11.0 Millimeters of mercury | Standard Deviation 11.31 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | SBP,Week 4,n=3,3,3,1,2 | -2.0 Millimeters of mercury | Standard Deviation 8.49 |
Secondary
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 12,n=2,1,1,1,0 | -5.0 Millimeters of mercury | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 4,n=2,1,1,2,2 | 5.0 Millimeters of mercury | Standard Deviation 21.21 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 8,n=2,1,1,2,1 | 14.0 Millimeters of mercury | Standard Deviation 8.49 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 12,n=2,1,1,1,0 | 7.0 Millimeters of mercury | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 16,n=2,0,0,1,0 | 0.0 Millimeters of mercury | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 24,n=2,0,0,0,0 | 8.0 Millimeters of mercury | Standard Deviation 0 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 36,n=2,0,0,0,0 | 11.0 Millimeters of mercury | Standard Deviation 9.9 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 38,n=1,0,0,0,0 | -6.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 40,n=1,0,0,0,0 | -10.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week follow up,n=2,1,0,1,1 | 3.0 Millimeters of mercury | Standard Deviation 18.38 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 2,n=1,1,0,1,2 | -10.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 4,n=2,1,1,2,2 | -3.0 Millimeters of mercury | Standard Deviation 12.73 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 8,n=2,1,1,2,1 | 3.0 Millimeters of mercury | Standard Deviation 4.24 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 2,n=1,1,0,1,2 | 2.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 16,n=2,0,0,1,0 | -5.0 Millimeters of mercury | Standard Deviation 7.07 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 24,n=2,0,0,0,0 | 1.0 Millimeters of mercury | Standard Deviation 1.41 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 36,n=2,0,0,0,0 | -2.0 Millimeters of mercury | Standard Deviation 2.83 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 38,n=1,0,0,0,0 | -8.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 40,n=1,0,0,0,0 | -10.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week follow up,n=2,1,0,1,1 | -2.0 Millimeters of mercury | Standard Deviation 5.66 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 2,n=1,1,0,1,2 | -8.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 12,n=2,1,1,1,0 | 14.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 8,n=2,1,1,2,1 | 18.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 12,n=2,1,1,1,0 | -5.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 4,n=2,1,1,2,2 | -15.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week follow up,n=2,1,0,1,1 | -1.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 8,n=2,1,1,2,1 | -5.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 4,n=2,1,1,2,2 | 0.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 2,n=1,1,0,1,2 | 15.0 Millimeters of mercury | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week follow up,n=2,1,0,1,1 | -7.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 4,n=2,1,1,2,2 | 6.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 12,n=2,1,1,1,0 | 1.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 8,n=2,1,1,2,1 | -4.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 4,n=2,1,1,2,2 | 6.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 12,n=2,1,1,1,0 | 8.0 Millimeters of mercury | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 8,n=2,1,1,2,1 | -12.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 16,n=2,0,0,1,0 | 11.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 12,n=2,1,1,1,0 | 4.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 14,n=0,0,0,1,0 | 7.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week follow up,n=2,1,0,1,1 | 22.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 2,n=1,1,0,1,2 | 0.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 16,n=2,0,0,1,0 | 15.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 4,n=2,1,1,2,2 | 2.0 Millimeters of mercury | Standard Deviation 5.66 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week follow up,n=2,1,0,1,1 | 21.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 2,n=1,1,0,1,2 | 0.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 4,n=2,1,1,2,2 | -1.5 Millimeters of mercury | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 8,n=2,1,1,2,1 | -11.5 Millimeters of mercury | Standard Deviation 10.61 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 8,n=2,1,1,2,1 | 4.0 Millimeters of mercury | Standard Deviation 2.83 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 12,n=2,1,1,1,0 | 2.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 14,n=0,0,0,1,0 | 9.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week follow up,n=2,1,0,1,1 | 3.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 8,n=2,1,1,2,1 | 5.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 8,n=2,1,1,2,1 | -1.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week follow up,n=2,1,0,1,1 | 12.0 Millimeters of mercury | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 4,n=2,1,1,2,2 | 1.5 Millimeters of mercury | Standard Deviation 0.71 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | SBP,Week 2,n=1,1,0,1,2 | 6.5 Millimeters of mercury | Standard Deviation 19.09 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 4,n=2,1,1,2,2 | 4.5 Millimeters of mercury | Standard Deviation 3.54 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | DBP,Week 2,n=1,1,0,1,2 | 7.0 Millimeters of mercury | Standard Deviation 9.9 |
Secondary
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 0.06 Celsius | Standard Deviation 0.305 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | 0.10 Celsius | Standard Deviation 0.458 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.10 Celsius | Standard Deviation 0.566 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -0.30 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 0.00 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | 0.07 Celsius | Standard Deviation 0.115 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 24,n=0,1,0,0,0 | 0.00 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 36,n=0,1,0,0,0 | 0.00 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 0.20 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 0.15 Celsius | Standard Deviation 0.265 |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.40 Celsius | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.00 Celsius | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | 0.00 Celsius | Standard Deviation 0.3 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | -0.10 Celsius | Standard Deviation 0.283 |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | 0.00 Celsius | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 0.00 Celsius | Standard Deviation 0.283 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | 0.00 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,1,1,1,0 | -0.10 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | -0.20 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | -0.13 Celsius | Standard Deviation 0.252 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=1,1,1,1,1 | -0.50 Celsius | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week follow up,n=5,4,2,3,2 | 0.20 Celsius | Standard Deviation 0.283 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=2,1,2,0,2 | 0.05 Celsius | Standard Deviation 0.354 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=3,3,3,1,2 | 0.10 Celsius | Standard Deviation 0.283 |
Secondary
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Time frame: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 40,n=1,0,0,0,0 | 0.00 Celsius | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | 0.15 Celsius | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.20 Celsius | — |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.15 Celsius | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -0.15 Celsius | Standard Deviation 0.212 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | -0.25 Celsius | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | -0.05 Celsius | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 24,n=2,0,0,0,0 | -0.42 Celsius | Standard Deviation 0.163 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 36,n=2,0,0,0,0 | -0.25 Celsius | Standard Deviation 0.071 |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 38,n=1,0,0,0,0 | 0.00 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | 0.00 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | 0.50 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.90 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -0.50 Celsius | — |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 0.00 Celsius | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | 0.10 Celsius | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.50 Celsius | — |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -0.30 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | 0.50 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -0.20 Celsius | Standard Deviation 0 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | -0.40 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=2,0,0,1,0 | -0.10 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 14,n=0,0,0,1,0 | -0.20 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=2,1,1,1,0 | 0.00 Celsius | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | -0.10 Celsius | Standard Deviation 0.141 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week follow up,n=2,1,0,1,1 | -0.60 Celsius | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2,n=1,1,0,1,2 | -0.65 Celsius | Standard Deviation 0.071 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=2,1,1,2,2 | 0.30 Celsius | Standard Deviation 1.414 |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=2,1,1,2,1 | -0.50 Celsius | — |
Secondary
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=0,0,0,1,1 | 203.750 Milligrams |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 24,n=0,0,0,1,0 | 397.500 Milligrams |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=0,0,0,1,1 | 357.500 Milligrams |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 32,n=0,0,0,0,1 | 1211.250 Milligrams |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 4,n=0,0,0,1,1 | 325.000 Milligrams |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 8,n=0,0,0,1,1 | 596.250 Milligrams |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 12,n=0,0,0,0,1 | 830.000 Milligrams |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 16,n=0,0,0,0,1 | 1020.000 Milligrams |
| Unknown | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 38,n=0,0,0,0,0 | — Milligrams |
| Unknown | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 14,n=0,0,0,0,0 | — Milligrams |
| Unknown | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 28,n= 0,0,0,0,0 | — Milligrams |
| Unknown | Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B | Week 2, n=0,0,0,0,0 | — Milligrams |
Secondary
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2, n=0,0,0,1,1 | 561.000 Milligrams | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 16,n=0,0,0,1,0 | 1233.750 Milligrams | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 24,n=0,0,0,1,0 | 1853.750 Milligrams | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 28,n=0,0,0,1,0 | 1908.500 Milligrams | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 38,n=0,0,0,1,0 | 2153.750 Milligrams | — |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=0,0,0,2,1 | 596.125 Milligrams | Standard Deviation 586.7219 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 8,n=0,0,0,2,0 | 956.125 Milligrams | Standard Deviation 851.8869 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=0,0,0,2,1 | 1201.125 Milligrams | Standard Deviation 1000.3793 |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 14,n=0,0,0,1,0 | 843.750 Milligrams | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 2, n=0,0,0,1,1 | 550.000 Milligrams | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 32,n=0,0,0,0,1 | 1600.000 Milligrams | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 4,n=0,0,0,2,1 | 775.000 Milligrams | — |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Week 12,n=0,0,0,2,1 | 1600.000 Milligrams | — |
Secondary
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Time frame: Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Stand Up From a Straight Chair | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Stand Up From a Straight Chair | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Lift a Full Cup or Glass to Mout | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85 Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open r car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing- Floor | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of a car | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of Bed | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open r car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12,Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373,Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Dress yourself | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64,Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Bend Down Pick Up Clothing- Floor | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Climb Up Five Steps | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Walk Outdoors on Flat Ground | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85 Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Lift a Full Cup or Glass to Mout | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85 Able to Do Chores | 1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Dress yourself | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Lift a Full Cup or Glass to Mout | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Shampoo your hair | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Cut your meat | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open car doors | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open Jars Previously Opened | 1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Take a Tub Bath | 1 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open r car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open r car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85 Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Able to Do Chores | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of a car | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Run Errands and Shop | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of Bed | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Lift a Full Cup or Glass to Mout | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Dress yourself | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Shampoo your hair | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Cut your meat | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open a New Milk Carton | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open car doors | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open Jars Previously Opened | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Turn Faucets On And Off | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get On and Off The Toilet | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Take a Tub Bath | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Wash and Dry Your Body | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Climb Up Five Steps | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open car doors | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Turn Faucets On And Off | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open Jars Previously Opened | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of a car | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Able to Do Chores | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of a car | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Climb Up Five Steps | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open r car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Run Errands and Shop | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get In and Out of Bed | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Turn Faucets On And Off | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Able to Do Chores | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Dress yourself | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Shampoo your hair | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Wash and Dry Your Body | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Cut your meat | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open Jars Previously Opened | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Wash and Dry Your Body | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Climb Up Five Steps | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Lift a Full Cup or Glass to Mouth | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get On and Off The Toilet | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Take a Tub Bath | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Shampoo your hair | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Dress yourself | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12,Take a Tub Bath | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Cut your meat | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85,Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Stand Up From a Straight Chair | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Open a New Milk Carton | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Get On and Off The Toilet | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Lift a Full Cup or Glass to Mout | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85 Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Lift a Full Cup or Glass to Mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Get In and Out of Bed | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 113, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open a New Milk Carton | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 85, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Bend Down Pick Up Clothing- Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Week 12, Bend Down Pick Up Clothing- Floor | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 373, Stand Up From a Straight Chair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Run Errands and Shop | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 112, Open car doors | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169,Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 29, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 64, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 65, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 169, Wash and Dry Your Body | NA Scores on scale |
Secondary
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Time frame: Day 87, 339, 344, Week 12, 24
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Turn Faucets On And Off | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open Jars Previously Opened | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bend Down Pick Up Clothing-Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing-Floor | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Take a Tub Bath | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | 2 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344,Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Shampoo your hair | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Open a New Milk Carton | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Stand Up From a Straight | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Able to Do Chores | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Stand Up From a Straight | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bend Down Pick Up Clothing-Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open a New Milk Carton | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Take a Tub Bath | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open Jars Previously Opened | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open car doors | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open a New Milk Carton | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Take a Tub Bath | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Turn Faucets On And Off | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Stand Up From a Straight | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bend Down Pick Up Clothing-Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bend Down Pick Up Clothing-Floor | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Dress yourself | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bend Down Pick Up Clothing-Floor | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Stand Up From a Straight | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Take a Tub Bath | 3 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Able to Do Chores | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Able to Do Chores | 1 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Stand Up From a Straight | 0 Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Dress yourself | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Shampoo your hair | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Cut your meat | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open a New Milk Carton | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open car doors | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open Jars Previously Opened | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Turn Faucets On And Off | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get On and Off The Toilet | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Take a Tub Bath | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Wash and Dry Your Body | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Bend Down Pick Up Clothing-Floor | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Climb Up Five Steps | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344,Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Able to Do Chores | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get In and Out of a car | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Run Errands and Shop | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get In and Out of Bed | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Stand Up From a Straight | 0 Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open a New Milk Carton | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open car doors | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open Jars Previously Opened | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Turn Faucets On And Off | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get On and Off The Toilet | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Take a Tub Bath | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Wash and Dry Your Body | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Climb Up Five Steps | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Able to Do Chores | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get In and Out of a car | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Run Errands and Shop | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get In and Out of Bed | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Stand Up From a Straight | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Dress yourself | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Shampoo your hair | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Cut your meat | NA Scores on scale |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get In and Out of a car | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Able to Do Chores | 1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Walk Outdoors on Flat Ground | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Climb Up Five Steps | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head | 1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Bend Down Pick Up Clothing-Floor | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Wash and Dry Your Body | 1 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Take a Tub Bath | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get On and Off The Toilet | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Turn Faucets On And Off | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Open Jars Previously Opened | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Open a New Milk Carton | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Lift a Full Cup/Glass to mouth | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Dress yourself | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Stand Up From a Straight | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Cut your meat | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get In and Out of Bed | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Run Errands and Shop | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Shampoo your hair | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Shampoo your hair | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 24, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344,Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Dress yourself | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Get In and Out of a car | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Lift a Full Cup/Glass to mouth | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Stand Up From a Straight | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Wash and Dry Your Body | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Take a Tub Bath | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Bend Down Pick Up Clothing-Floor | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Get On and Off The Toilet | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Turn Faucets On And Off | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Get In and Out of Bed | 0 Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Climb Up Five Steps | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open Jars Previously Opened | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 339, Cut your meat | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 344, Walk Outdoors on Flat Ground | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Week 24, Open car doors | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Week 12, Able to Do Chores | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Week 12, Open a New Milk Carton | NA Scores on scale |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 87, Run Errands and Shop | 0 Scores on scale |
Secondary
Part B: Number of Disease Flares Over Time
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 40, n=1,0,0,0,0 | 2 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 2, n=1,1,0,1,2 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 4, n=5,4,4,3,4 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 8, n=4,2,3,2,3 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 12, n=3,2,2,2,1 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 24, n=2,1,0,0,0 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 36, n=2,1,0,0,0 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 38, n=1,0,0,0,0 | 2 Disease flares |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 16, n=2,1,1,2,0 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 12, n=3,2,2,2,1 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 4, n=5,4,4,3,4 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 8, n=4,2,3,2,3 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 2, n=1,1,0,1,2 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 16, n=2,1,1,2,0 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 36, n=2,1,0,0,0 | 0 Disease flares |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 24, n=2,1,0,0,0 | 0 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 8, n=4,2,3,2,3 | 1 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 4, n=5,4,4,3,4 | 0 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 12, n=3,2,2,2,1 | 1 Disease flares |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 16, n=2,1,1,2,0 | 0 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 14, n=0,0,0,1,0 | 1 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 8, n=4,2,3,2,3 | 0 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 16, n=2,1,1,2,0 | 1 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 4, n=5,4,4,3,4 | 0 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 2, n=1,1,0,1,2 | 0 Disease flares |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 12, n=3,2,2,2,1 | 0 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 12, n=3,2,2,2,1 | 0 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 8, n=4,2,3,2,3 | 0 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 4, n=5,4,4,3,4 | 0 Disease flares |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Disease Flares Over Time | Week 2, n=1,1,0,1,2 | 0 Disease flares |
Secondary
Part B: Number of Hospitalizations for Disease Flare Over Time
Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Time frame: Up to Week 104
Population: ITT-Part B Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Hospitalizations for Disease Flare Over Time | 0 Number of hospitalizations |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Hospitalizations for Disease Flare Over Time | 0 Number of hospitalizations |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Hospitalizations for Disease Flare Over Time | 0 Number of hospitalizations |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Hospitalizations for Disease Flare Over Time | 0 Number of hospitalizations |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Hospitalizations for Disease Flare Over Time | 0 Number of hospitalizations |
Secondary
Part B: Number of Participants in Sustained Remission Over Time
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30millimeters per hour\] and CRP \[\<1milligram/deciliter\]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.
Time frame: Weeks 4, 8 and 12
Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants in Sustained Remission Over Time | Week 8,n=1,0,1,0,0 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants in Sustained Remission Over Time | Week 4,n=1,1,1,0,0 | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants in Sustained Remission Over Time | Week 12,n=1,0,0,0,0 | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants in Sustained Remission Over Time | Week 4,n=1,1,1,0,0 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants in Sustained Remission Over Time | Week 4,n=1,1,1,0,0 | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants in Sustained Remission Over Time | Week 8,n=1,0,1,0,0 | 1 Participants |
Secondary
Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Population: ITT-Part B Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare | 0 Participants |
Secondary
Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30 millimeters per hour\] and CRP \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.
Time frame: Week 24
Population: ITT-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | NA Participants |
Secondary
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Time frame: Up to 120 weeks
Population: Safety-Part B Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All AEs | 4 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | Corticosteroid related AEs | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All AEs | 3 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | Corticosteroid related AEs | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All AEs | 2 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | Corticosteroid related AEs | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All AEs | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | Corticosteroid related AEs | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | All AEs | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B | Corticosteroid related AEs | 1 Participants |
Secondary
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Time frame: Up to 120 weeks
Population: Safety-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All AEs | 2 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Corticosteroid related AEs | 0 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All AEs | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Corticosteroid related AEs | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All AEs | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Corticosteroid related AEs | 0 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All AEs | 2 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Corticosteroid related AEs | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All SAEs | 0 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | All AEs | 2 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B | Corticosteroid related AEs | 1 Participants |
Secondary
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Time frame: Baseline (Day 1)
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 1: Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 1: No change | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 1: No change | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 1: Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 1: Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 1: Much Better | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 1: Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 1: Better | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 1: No change | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 1: Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 1: Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 1: Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 1: Much Better | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 1: No change | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 1: Better | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 1: Much Better | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 1: Much Better | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 12, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 15, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 1, Day 1: No change | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 11, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 16, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 5, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 10, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 9, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 8, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 6, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 13, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 17, Day 1: Much Better | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 14, Day 1: Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B | Par 18, Day 1: Much Better | 1 Participants |
Secondary
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Time frame: Baseline (Day 1), Days 103 and 271
Population: ITT-Part B Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 103: No change | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 271: Worse | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 1: Slightly Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5,Day 1: Slightly Better | NA Participants |
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 1: Slightly Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 271: Worse | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | 1 Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5,Day 1: Slightly Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 103: No change | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 1: Better | NA Participants |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | 1 Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 271: Worse | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 1: Slightly Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 1: Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 103: No change | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5,Day 1: Slightly Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 271: Worse | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5,Day 1: Slightly Better | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 103: No change | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 1: Better | 1 Participants |
| PartA:Placebo SC q2w + 6 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 1: Slightly Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5,Day 1: Slightly Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 4, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 3, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 8, Day 1: Slightly Better | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 7, Day 1: Much Better | 1 Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 271: Worse | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 2, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 1, Day 1: Much Better | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 5, Day 103: No change | NA Participants |
| PartA:Placebo SC q2w + 12 Month Prednisone | Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B | Par 6, Day 1: Better | NA Participants |
Secondary
Part B: Time to First Disease Flare for Participants in Sustained Remission
Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.
Time frame: Week 52
Population: ITT-Part B Population. Only those participants with available data at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PartA:SIR 100 mg SC q2w+6 Month Prednisone | Part B: Time to First Disease Flare for Participants in Sustained Remission | NA Days |
| PartA:SIR 100 mg SC q2w+3 Month Prednisone | Part B: Time to First Disease Flare for Participants in Sustained Remission | NA Days |
| PartA:SIR 50 mg SC q4w+6 Month Prednisone | Part B: Time to First Disease Flare for Participants in Sustained Remission | NA Days |