Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid arthritis, GSK3196165, Otilimab, Long-term safety, Long-term efficacy
Brief summary
RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X \[209564: NCT04333147\]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) \[csDMARD(s)\] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study
Interventions
BIOLOGICALOtilimab (GSK3196165)
GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.
DRUGcsDMARD(s)
Stable dose of csDMARD(s) as standard of care (SoC).
Sponsors
Iqvia Pty Ltd
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a parallel group treatment study with two arms that are initially participant and investigator blinded. A participant's treatment allocation will remain blinded at least until their qualifying study has been reported.
Intervention model description
Participants who received GSK3196165 in their qualifying study will continue in this study on the same dose. Participants who received a comparator (tofacitinib or sarilumab) in their qualifying study will be centrally randomized using interactive response technology (IRT) in a ratio of 1:1 to either GSK3196165 90 mg or 150 mg.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with rheumatoid arthritis who are aged \>=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165. * Body weight \>=40 kilograms (kg). * Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).
Exclusion criteria
* Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study. * Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that * Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or * Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study. * Current or previous active TB regardless of treatment. * Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation. * A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator. * Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease. * Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation. * Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study. * Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study. * Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant. * Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding. * History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Baseline (Day 01) and Week 24 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Baseline (Day 01) and Week 48 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Baseline (Day 01) and Week 96 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Baseline (Day 01) and Week 144 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides |
| Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Up to approximately 145 Weeks | Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline. |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Up to approximately 145 Weeks | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included. |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | Baseline (Day 01) and Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | Baseline (Day 01) and Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | Baseline (Day 01) and Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | Baseline (Day 01) and Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 24, 48, 96 and 144 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off. |
| Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 24, 48, 96 and 144 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off. |
| Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 24, 48, 96 and 132 | The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off. |
| Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI \<= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off. |
| Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 24, 48, 96 and 144 | CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. |
| Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 24, 48, 96 and 144 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. |
| Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 24, 48, 96 and 132 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. |
| Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Week 24 and 48 | Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. |
| Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 24, 48, 96 and 144 | The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 without any difficulty to 3 unable to do. Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life. |
| Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 24, 48, 96 and 144 | For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at 0 (no pain) and 100 (most severe pain). A negative change from baseline indicates an improvement. |
| Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 24, 48, 96 and 144 | SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring. |
| Absolute Values SF-36 Domain Scores | Week 24, 48, 96 and 144 | Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36. |
| Absolute Values SF-36 Physical Component Scores (PCS) | Week 24, 48, 96 and 144 | SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring. |
| Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 24, 48, 96 and 144 | The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. |
| Number of Participants With Anti-GSK3196165 Antibodies | Week 120 | Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA |
| Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 24, 48, 96 and 144 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Percentage values are rounded off. |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Malaysia, Mexico, Poland, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants who consented, were enrolled and assigned to receive Otilimab 90 milligram (mg) or 150 mg weekly. Participants who received Otilimab in their qualifying study (202018, 201790 and 201791) were enrolled into this study on the same dose. Participants who received an active comparator in their qualifying study were centrally randomized using Interactive Response Technology (IRT) in a ratio of 1:1 to receive either Otilimab 90 mg or 150 mg weekly.
Pre-assignment details
The participants in this study 209564 (ContRAst X) were adults with Rheumatoid Arthritis (RA) who completed the treatment phase of a qualifying Otilimab clinical study (Phase 3 studies 201790 \[ContRAst 1\], 201791 \[ContRAst 2\] or 202018 \[ContRAst 3\]) and who, in the investigator's and participant's judgement would have benefited from extended treatment with Otilimab. One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision (N=1459).
Participants by arm
| Arm | Count |
|---|---|
| Otilimab 90 mg Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly. | 1,456 |
| Otilimab 150 mg Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. | 1,459 |
| Total | 2,915 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 43 | 40 |
| Overall Study | INVESTIGATOR SITE CLOSED | 6 | 2 |
| Overall Study | Lack of Efficacy | 49 | 48 |
| Overall Study | Lost to Follow-up | 19 | 16 |
| Overall Study | Physician Decision | 17 | 20 |
| Overall Study | PROTOCOL-SPECIFIED WITHDRAWAL CRITERION MET | 6 | 9 |
| Overall Study | STUDY TERMINATED BY SPONSOR | 1,251 | 1,256 |
| Overall Study | Withdrawal by Subject | 65 | 68 |
Baseline characteristics
| Characteristic | Otilimab 150 mg | Total | Otilimab 90 mg |
|---|---|---|---|
| Age, Continuous | 55.7 YEARS STANDARD_DEVIATION 10.91 | 55.4 YEARS STANDARD_DEVIATION 11.15 | 55.2 YEARS STANDARD_DEVIATION 11.38 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 53 Participants | 93 Participants | 40 Participants |
| Race/Ethnicity, Customized ASIAN | 206 Participants | 429 Participants | 223 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 28 Participants | 61 Participants | 33 Participants |
| Race/Ethnicity, Customized MULTIPLE | 15 Participants | 28 Participants | 13 Participants |
| Race/Ethnicity, Customized WHITE | 1157 Participants | 2304 Participants | 1147 Participants |
| Sex: Female, Male Female | 1181 Participants | 2339 Participants | 1158 Participants |
| Sex: Female, Male Male | 278 Participants | 576 Participants | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 1,456 | 9 / 1,459 |
| other Total, other adverse events | 279 / 1,456 | 308 / 1,459 |
| serious Total, serious adverse events | 123 / 1,456 | 114 / 1,459 |
Outcome results
Primary
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Time frame: Baseline (Day 01) and Week 144
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Gamma Glutamyl Transferase (GGT) | -21.0 International units per liter (IU/L) | — |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Alkaline Phosphatase (AP) | 39.0 International units per liter (IU/L) | — |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Creatine Kinase (CPK) | -47.0 International units per liter (IU/L) | — |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Aspartate Aminotransferase (AST) | -8.0 International units per liter (IU/L) | — |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Alanine Aminotransferase (ALT) | -14.0 International units per liter (IU/L) | — |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Creatine Kinase (CPK) | -2.5 International units per liter (IU/L) | Standard Deviation 31.82 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Aspartate Aminotransferase (AST) | 2.0 International units per liter (IU/L) | Standard Deviation 0 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Alkaline Phosphatase (AP) | -1.5 International units per liter (IU/L) | Standard Deviation 6.36 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Gamma Glutamyl Transferase (GGT) | 5.0 International units per liter (IU/L) | Standard Deviation 14.14 |
Primary
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Time frame: Baseline (Day 01) and Week 24
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Alanine Aminotransferase (ALT) | 0.0 International units per liter (IU/L) | Standard Deviation 15.8 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Gamma Glutamyl Transferase (GGT) | -0.9 International units per liter (IU/L) | Standard Deviation 20.32 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Alkaline Phosphatase (AP) | 3.0 International units per liter (IU/L) | Standard Deviation 18.85 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Creatine Kinase (CPK) | 5.4 International units per liter (IU/L) | Standard Deviation 103.03 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Aspartate Aminotransferase (AST) | 1.0 International units per liter (IU/L) | Standard Deviation 11.09 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Creatine Kinase (CPK) | -3.8 International units per liter (IU/L) | Standard Deviation 66.66 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Aspartate Aminotransferase (AST) | 0.8 International units per liter (IU/L) | Standard Deviation 9.7 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Alanine Aminotransferase (ALT) | -0.1 International units per liter (IU/L) | Standard Deviation 15.2 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Alkaline Phosphatase (AP) | 3.1 International units per liter (IU/L) | Standard Deviation 21.05 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Gamma Glutamyl Transferase (GGT) | -0.4 International units per liter (IU/L) | Standard Deviation 18.94 |
Primary
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Time frame: Baseline (Day 01) and Week 48
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Alanine Aminotransferase (ALT) | -0.9 International units per liter (IU/L) | Standard Deviation 16.35 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Gamma Glutamyl Transferase (GGT) | -0.0 International units per liter (IU/L) | Standard Deviation 22.44 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Alkaline Phosphatase (AP) | 5.4 International units per liter (IU/L) | Standard Deviation 20.07 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Creatine Kinase (CPK) | 7.8 International units per liter (IU/L) | Standard Deviation 153.24 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Aspartate Aminotransferase (AST) | 0.4 International units per liter (IU/L) | Standard Deviation 11.11 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Creatine Kinase (CPK) | -3.7 International units per liter (IU/L) | Standard Deviation 71.52 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Aspartate Aminotransferase (AST) | 0.4 International units per liter (IU/L) | Standard Deviation 11.32 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Alanine Aminotransferase (ALT) | -1.2 International units per liter (IU/L) | Standard Deviation 16.26 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Alkaline Phosphatase (AP) | 5.2 International units per liter (IU/L) | Standard Deviation 21.32 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Gamma Glutamyl Transferase (GGT) | -0.4 International units per liter (IU/L) | Standard Deviation 22.14 |
Primary
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Time frame: Baseline (Day 01) and Week 96
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Alanine Aminotransferase (ALT) | -2.4 International units per liter (IU/L) | Standard Deviation 19.02 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Gamma Glutamyl Transferase (GGT) | -1.9 International units per liter (IU/L) | Standard Deviation 18.52 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Alkaline Phosphatase (AP) | 0.0 International units per liter (IU/L) | Standard Deviation 18.98 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Creatine Kinase (CPK) | 1.4 International units per liter (IU/L) | Standard Deviation 39.73 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Aspartate Aminotransferase (AST) | 0.1 International units per liter (IU/L) | Standard Deviation 11.65 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Creatine Kinase (CPK) | 3.6 International units per liter (IU/L) | Standard Deviation 93.29 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Aspartate Aminotransferase (AST) | 2.0 International units per liter (IU/L) | Standard Deviation 7.47 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Alanine Aminotransferase (ALT) | -1.1 International units per liter (IU/L) | Standard Deviation 9.33 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Alkaline Phosphatase (AP) | 8.6 International units per liter (IU/L) | Standard Deviation 27.79 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Gamma Glutamyl Transferase (GGT) | -0.1 International units per liter (IU/L) | Standard Deviation 19.67 |
Primary
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Time frame: Baseline (Day 01) and Week 144
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Total Bilirubin | 4.0 Micromoles per liter (umol/L) | — |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Direct Bilirubin | 2.000 Micromoles per liter (umol/L) | — |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Total Bilirubin | 4.5 Micromoles per liter (umol/L) | Standard Deviation 6.36 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Direct Bilirubin | 1.500 Micromoles per liter (umol/L) | Standard Deviation 0.707 |
Primary
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Time frame: Baseline (Day 01) and Week 24
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Total Bilirubin | 0.3 Micromoles per liter (umol/L) | Standard Deviation 2.87 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Direct Bilirubin | 0.053 Micromoles per liter (umol/L) | Standard Deviation 0.764 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Total Bilirubin | 0.3 Micromoles per liter (umol/L) | Standard Deviation 2.92 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Direct Bilirubin | 0.027 Micromoles per liter (umol/L) | Standard Deviation 0.641 |
Primary
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Time frame: Baseline (Day 01) and Week 48
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Direct Bilirubin | 0.011 Micromoles per liter (umol/L) | Standard Deviation 0.777 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Total Bilirubin | -0.0 Micromoles per liter (umol/L) | Standard Deviation 2.85 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Total Bilirubin | 0.1 Micromoles per liter (umol/L) | Standard Deviation 3.04 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Direct Bilirubin | 0.040 Micromoles per liter (umol/L) | Standard Deviation 0.69 |
Primary
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Time frame: Baseline (Day 01) and Week 96
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Total Bilirubin | -0.2 Micromoles per liter (umol/L) | Standard Deviation 3.22 |
| Otilimab 90 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Direct Bilirubin | 0.047 Micromoles per liter (umol/L) | Standard Deviation 0.815 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Total Bilirubin | 0.5 Micromoles per liter (umol/L) | Standard Deviation 3.49 |
| Otilimab 150 mg | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Direct Bilirubin | 0.041 Micromoles per liter (umol/L) | Standard Deviation 0.827 |
Primary
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Time frame: Baseline (Day 01) and Week 144
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | -1.0 Gram Per Liter (g/L) | — |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | 2.0 Gram Per Liter (g/L) | Standard Deviation 2.83 |
Primary
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Time frame: Baseline (Day 01) and Week 24
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | 0.4 Gram Per Liter (g/L) | Standard Deviation 10.1 |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | 0.3 Gram Per Liter (g/L) | Standard Deviation 9.89 |
Primary
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Time frame: Baseline (Day 01) and Week 48
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | -0.5 Gram Per Liter (g/L) | Standard Deviation 10.38 |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | -1.1 Gram Per Liter (g/L) | Standard Deviation 10.62 |
Primary
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Time frame: Baseline (Day 01) and Week 96
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | 1.0 Gram Per Liter (g/L) | Standard Deviation 11.37 |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | 1.2 Gram Per Liter (g/L) | Standard Deviation 10.24 |
Primary
Change From Baseline in Hematology Parameter of Platelet Count at Week 144
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Time frame: Baseline (Day 01) and Week 144
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | 17.0 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | -37.5 Giga cells per liter (10^9 cells/L) | Standard Deviation 40.31 |
Primary
Change From Baseline in Hematology Parameter of Platelet Count at Week 24
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Time frame: Baseline (Day 01) and Week 24
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | -11.9 Giga cells per liter (10^9 cells/L) | Standard Deviation 66.86 |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | -9.7 Giga cells per liter (10^9 cells/L) | Standard Deviation 66.82 |
Primary
Change From Baseline in Hematology Parameter of Platelet Count at Week 48
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Time frame: Baseline (Day 01) and Week 48
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | -12.5 Giga cells per liter (10^9 cells/L) | Standard Deviation 66.47 |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | -7.6 Giga cells per liter (10^9 cells/L) | Standard Deviation 71.36 |
Primary
Change From Baseline in Hematology Parameter of Platelet Count at Week 96
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Time frame: Baseline (Day 01) and Week 96
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | -13.8 Giga cells per liter (10^9 cells/L) | Standard Deviation 60.72 |
| Otilimab 150 mg | Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | -5.7 Giga cells per liter (10^9 cells/L) | Standard Deviation 72.81 |
Primary
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Time frame: Baseline (Day 01) and Week 144
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Cholesterol | -2.360 Millimoles per liter (mmol/L) | — |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | HDL Cholesterol, Direct | 0.160 Millimoles per liter (mmol/L) | — |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | LDL Cholesterol | -2.250 Millimoles per liter (mmol/L) | — |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Triglycerides | -0.580 Millimoles per liter (mmol/L) | — |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Triglycerides | -0.865 Millimoles per liter (mmol/L) | Standard Deviation 0.9687 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Cholesterol | -2.240 Millimoles per liter (mmol/L) | Standard Deviation 2.8709 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | LDL Cholesterol | -1.750 Millimoles per liter (mmol/L) | Standard Deviation 2.4183 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | HDL Cholesterol, Direct | -0.095 Millimoles per liter (mmol/L) | Standard Deviation 0.0212 |
Primary
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Time frame: Baseline (Day 01) and Week 24
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Cholesterol | -0.038 Millimoles per liter (mmol/L) | Standard Deviation 0.8542 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | HDL Cholesterol, Direct | -0.020 Millimoles per liter (mmol/L) | Standard Deviation 0.2703 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | LDL Cholesterol | -0.031 Millimoles per liter (mmol/L) | Standard Deviation 0.7239 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Triglycerides | 0.033 Millimoles per liter (mmol/L) | Standard Deviation 0.6503 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Triglycerides | 0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.7895 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Cholesterol | -0.011 Millimoles per liter (mmol/L) | Standard Deviation 0.9685 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | LDL Cholesterol | 0.010 Millimoles per liter (mmol/L) | Standard Deviation 0.7818 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | HDL Cholesterol, Direct | -0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.2869 |
Primary
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Time frame: Baseline (Day 01) and Week 48
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Cholesterol | -0.053 Millimoles per liter (mmol/L) | Standard Deviation 0.9271 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | HDL Cholesterol, Direct | -0.021 Millimoles per liter (mmol/L) | Standard Deviation 0.2979 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | LDL Cholesterol | -0.038 Millimoles per liter (mmol/L) | Standard Deviation 0.7865 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Triglycerides | 0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.6772 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Triglycerides | -0.019 Millimoles per liter (mmol/L) | Standard Deviation 0.7376 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Cholesterol | -0.078 Millimoles per liter (mmol/L) | Standard Deviation 0.9826 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | LDL Cholesterol | -0.034 Millimoles per liter (mmol/L) | Standard Deviation 0.7899 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | HDL Cholesterol, Direct | -0.027 Millimoles per liter (mmol/L) | Standard Deviation 0.2959 |
Primary
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Time frame: Baseline (Day 01) and Week 96
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Cholesterol | -0.178 Millimoles per liter (mmol/L) | Standard Deviation 1.035 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | HDL Cholesterol, Direct | -0.032 Millimoles per liter (mmol/L) | Standard Deviation 0.2665 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | LDL Cholesterol | -0.159 Millimoles per liter (mmol/L) | Standard Deviation 0.8948 |
| Otilimab 90 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Triglycerides | 0.009 Millimoles per liter (mmol/L) | Standard Deviation 0.8042 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Triglycerides | -0.056 Millimoles per liter (mmol/L) | Standard Deviation 0.7262 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Cholesterol | -0.130 Millimoles per liter (mmol/L) | Standard Deviation 1.057 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | LDL Cholesterol | -0.031 Millimoles per liter (mmol/L) | Standard Deviation 0.8546 |
| Otilimab 150 mg | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | HDL Cholesterol, Direct | -0.058 Millimoles per liter (mmol/L) | Standard Deviation 0.3233 |
Primary
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Time frame: Baseline (Day 01) and Week 144
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Total WBC | -1.00 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Eosinophils | -0.130 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Neutrophils | -0.360 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Basophils | 0.000 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Lymphocytes | -0.320 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Monocytes | -0.220 Giga cells per liter (10^9 cells/L) | — |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Basophils | 0.000 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0141 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Monocytes | 0.010 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0424 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Lymphocytes | 0.010 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.3253 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Total WBC | -0.85 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.061 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Neutrophils | -0.935 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.6718 |
Primary
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Time frame: Baseline (Day 01) and Week 24
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Neutrophils | -0.348 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.18 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Lymphocytes | -0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.55 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Monocytes | 0.003 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.18 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Eosinophils | 0.027 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1623 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Basophils | -0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0405 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Total WBC | -0.32 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.212 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Basophils | -0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.04 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Neutrophils | -0.390 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.13 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Eosinophils | 0.022 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.171 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Lymphocytes | -0.012 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.55 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Total WBC | -0.38 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.23 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Monocytes | 0.00 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.194 |
Primary
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Time frame: Baseline (Day 01) and Week 48
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Neutrophils | -0.318 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.2215 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Lymphocytes | -0.022 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.5385 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Monocytes | -0.002 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1871 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Eosinophils | 0.018 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1435 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Basophils | -0.004 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0391 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Total WBC | -0.33 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.283 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Basophils | -0.006 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0403 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Neutrophils | -0.541 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.1426 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Eosinophils | 0.028 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1844 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Lymphocytes | -0.051 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.5725 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Total WBC | -0.58 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.262 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Monocytes | -0.013 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.2461 |
Primary
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96
Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.
Time frame: Baseline (Day 01) and Week 96
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Lymphocytes | 0.090 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.6453 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Eosinophils | 0.025 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1725 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Neutrophils | -0.243 Giga cells per liter (10^9 cells/L) | Standard Deviation 1.8851 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Basophils | -0.007 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0423 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Monocytes | -0.042 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.2001 |
| Otilimab 90 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Total WBC | -0.18 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.043 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Total WBC | -0.53 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.568 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Neutrophils | -0.582 Giga cells per liter (10^9 cells/L) | Standard Deviation 2.4346 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Lymphocytes | 0.018 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.5816 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Monocytes | -0.001 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.2035 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Eosinophils | 0.029 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.1526 |
| Otilimab 150 mg | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Basophils | -0.013 Giga cells per liter (10^9 cells/L) | Standard Deviation 0.0346 |
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.
Time frame: Up to approximately 145 Weeks
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Otilimab 90 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Participants with AEs | 902 Participants |
| Otilimab 90 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Participants with SAEs | 123 Participants |
| Otilimab 90 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Participants with AESI | 120 Participants |
| Otilimab 150 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Participants with AEs | 931 Participants |
| Otilimab 150 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Participants with SAEs | 114 Participants |
| Otilimab 150 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Participants with AESI | 95 Participants |
Primary
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities
Number of participants with NCI-CTCAE \>=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case \>=Grade 3 shifts from Baseline.
Time frame: Up to approximately 145 Weeks
Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Otilimab 90 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hypercalcemia, Total, Grade 3 | 1 Participants |
| Otilimab 90 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hyperkalemia, Total, Grade 4 | 2 Participants |
| Otilimab 90 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hypernatremia, Total, Grade 3 | 1 Participants |
| Otilimab 90 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hypernatremia, Total, Grade 4 | 0 Participants |
| Otilimab 90 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Chronic Kidney Disease, Total, Grade 3 | 0 Participants |
| Otilimab 90 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Creatinine increased, Total, Grade 3 | 1 Participants |
| Otilimab 150 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Chronic Kidney Disease, Total, Grade 3 | 1 Participants |
| Otilimab 150 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hypercalcemia, Total, Grade 3 | 0 Participants |
| Otilimab 150 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hypernatremia, Total, Grade 4 | 1 Participants |
| Otilimab 150 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hyperkalemia, Total, Grade 4 | 0 Participants |
| Otilimab 150 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Creatinine increased, Total, Grade 3 | 0 Participants |
| Otilimab 150 mg | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Hypernatremia, Total, Grade 3 | 0 Participants |
Secondary
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)
For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at 0 (no pain) and 100 (most severe pain). A negative change from baseline indicates an improvement.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 96 | 39.3 Scores on a scale | Standard Deviation 24.62 |
| Otilimab 90 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 48 | 37.0 Scores on a scale | Standard Deviation 23.55 |
| Otilimab 90 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 24 | 34.6 Scores on a scale | Standard Deviation 23.51 |
| Otilimab 150 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 144 | 26.0 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 48 | 36.0 Scores on a scale | Standard Deviation 23.88 |
| Otilimab 150 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 24 | 36.6 Scores on a scale | Standard Deviation 23.85 |
| Otilimab 150 mg | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | Week 96 | 38.1 Scores on a scale | Standard Deviation 27.08 |
Secondary
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score
CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 96 | 14.62 Scores on a scale | Standard Deviation 11.443 |
| Otilimab 90 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 48 | 13.85 Scores on a scale | Standard Deviation 10.612 |
| Otilimab 90 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 24 | 13.42 Scores on a scale | Standard Deviation 10.669 |
| Otilimab 150 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 144 | 11.30 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 48 | 14.07 Scores on a scale | Standard Deviation 11.186 |
| Otilimab 150 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 24 | 14.26 Scores on a scale | Standard Deviation 11.637 |
| Otilimab 150 mg | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | Week 96 | 15.22 Scores on a scale | Standard Deviation 13.997 |
Secondary
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 96 | 3.44 Scores on a scale | Standard Deviation 1.188 |
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 48 | 3.51 Scores on a scale | Standard Deviation 1.224 |
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 24 | 3.49 Scores on a scale | Standard Deviation 1.237 |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 144 | 3.21 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 48 | 3.54 Scores on a scale | Standard Deviation 1.232 |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 24 | 3.55 Scores on a scale | Standard Deviation 1.269 |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | Week 96 | 3.52 Scores on a scale | Standard Deviation 1.389 |
Secondary
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter \[mm\]/hour\[hr\]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.
Time frame: Week 24, 48, 96 and 132
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 24 | 3.97 Scores on a scale | Standard Deviation 1.295 |
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 48 | 4.02 Scores on a scale | Standard Deviation 1.284 |
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 96 | 3.92 Scores on a scale | Standard Deviation 1.216 |
| Otilimab 90 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 132 | 3.77 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 132 | 4.26 Scores on a scale | Standard Deviation 1.56 |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 24 | 4.01 Scores on a scale | Standard Deviation 1.333 |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 96 | 4.04 Scores on a scale | Standard Deviation 1.47 |
| Otilimab 150 mg | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Week 48 | 4.05 Scores on a scale | Standard Deviation 1.306 |
Secondary
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 without any difficulty to 3 unable to do. Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 96 | 1.074 Scores on a scale | Standard Deviation 0.6852 |
| Otilimab 90 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 48 | 1.072 Scores on a scale | Standard Deviation 0.6679 |
| Otilimab 90 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 24 | 1.045 Scores on a scale | Standard Deviation 0.6764 |
| Otilimab 150 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 144 | 2.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 48 | 1.096 Scores on a scale | Standard Deviation 0.6691 |
| Otilimab 150 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 24 | 1.060 Scores on a scale | Standard Deviation 0.6849 |
| Otilimab 150 mg | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 96 | 1.156 Scores on a scale | Standard Deviation 0.7582 |
Secondary
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 96 | 35.2 Scores on a scale | Standard Deviation 10.77 |
| Otilimab 90 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 48 | 35.5 Scores on a scale | Standard Deviation 10.53 |
| Otilimab 90 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 24 | 36.0 Scores on a scale | Standard Deviation 10.33 |
| Otilimab 150 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 144 | 26.0 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 48 | 35.4 Scores on a scale | Standard Deviation 10.59 |
| Otilimab 150 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 24 | 35.9 Scores on a scale | Standard Deviation 10.25 |
| Otilimab 150 mg | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | Week 96 | 34.8 Scores on a scale | Standard Deviation 11.87 |
Secondary
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)
Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity.
Time frame: Week 24 and 48
Population: The analysis was performed on the ITT set that includes participants from qualifying studies 201790 and 201791 only who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Week 24 | 23.26 Scores on a scale | Standard Deviation 34.191 |
| Otilimab 90 mg | Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Week 48 | 23.27 Scores on a scale | Standard Deviation 33.953 |
| Otilimab 150 mg | Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Week 24 | 30.31 Scores on a scale | Standard Deviation 40.236 |
| Otilimab 150 mg | Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Week 48 | 30.34 Scores on a scale | Standard Deviation 40.432 |
Secondary
Absolute Values SF-36 Domain Scores
Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 24 | 67.47 Scores on a scale | Standard Deviation 19.387 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 48 | 52.22 Scores on a scale | Standard Deviation 21.099 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 96 | 49.90 Scores on a scale | Standard Deviation 20.943 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | General Health at week 24 | 51.00 Scores on a scale | Standard Deviation 18.744 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | General Health at week 48 | 50.35 Scores on a scale | Standard Deviation 18.817 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | General Health at week 96 | 48.44 Scores on a scale | Standard Deviation 20.029 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 24 | 54.49 Scores on a scale | Standard Deviation 21.457 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 48 | 67.64 Scores on a scale | Standard Deviation 19.701 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 96 | 66.90 Scores on a scale | Standard Deviation 20.86 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 24 | 56.20 Scores on a scale | Standard Deviation 25.644 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 48 | 54.23 Scores on a scale | Standard Deviation 26.222 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 96 | 51.87 Scores on a scale | Standard Deviation 25.735 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 24 | 74.79 Scores on a scale | Standard Deviation 24.653 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 48 | 75.31 Scores on a scale | Standard Deviation 24.008 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 96 | 73.35 Scores on a scale | Standard Deviation 25.188 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 24 | 58.58 Scores on a scale | Standard Deviation 23.155 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 48 | 56.49 Scores on a scale | Standard Deviation 23.645 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 96 | 54.27 Scores on a scale | Standard Deviation 23.818 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Social Function at week 24 | 71.20 Scores on a scale | Standard Deviation 24.001 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Social Function at week 48 | 70.88 Scores on a scale | Standard Deviation 24.596 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Social Function at week 96 | 68.25 Scores on a scale | Standard Deviation 24.065 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Vitality at week 24 | 55.77 Scores on a scale | Standard Deviation 20.69 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Vitality at week 48 | 55.24 Scores on a scale | Standard Deviation 20.972 |
| Otilimab 90 mg | Absolute Values SF-36 Domain Scores | Vitality at week 96 | 51.04 Scores on a scale | Standard Deviation 23.127 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 48 | 53.98 Scores on a scale | Standard Deviation 25.397 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Social Function at week 24 | 71.39 Scores on a scale | Standard Deviation 23.936 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 96 | 50.92 Scores on a scale | Standard Deviation 26.175 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 144 | 35.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Vitality at week 96 | 54.25 Scores on a scale | Standard Deviation 22.738 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 24 | 75.09 Scores on a scale | Standard Deviation 24.76 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Social Function at week 48 | 71.29 Scores on a scale | Standard Deviation 24.123 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 48 | 76.18 Scores on a scale | Standard Deviation 24.163 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Vitality at week 48 | 54.49 Scores on a scale | Standard Deviation 21.262 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 24 | 53.83 Scores on a scale | Standard Deviation 21.158 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 96 | 74.44 Scores on a scale | Standard Deviation 26.324 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 48 | 52.94 Scores on a scale | Standard Deviation 21.158 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Emotional At week 144 | 50.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 96 | 51.11 Scores on a scale | Standard Deviation 21.983 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Bodily Pain at Week 144 | 41.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Social Function at week 96 | 69.43 Scores on a scale | Standard Deviation 26.526 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | General Health at week 24 | 50.30 Scores on a scale | Standard Deviation 17.98 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 24 | 57.78 Scores on a scale | Standard Deviation 23.514 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | General Health at week 48 | 49.44 Scores on a scale | Standard Deviation 17.645 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Social Function at week 144 | 62.50 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | General Health at week 96 | 46.73 Scores on a scale | Standard Deviation 18.543 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | General Health at week 144 | 45.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 48 | 57.57 Scores on a scale | Standard Deviation 23.463 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 24 | 68.05 Scores on a scale | Standard Deviation 19.15 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Vitality at week 144 | 50.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 48 | 67.97 Scores on a scale | Standard Deviation 19.636 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 96 | 55.15 Scores on a scale | Standard Deviation 24.956 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 96 | 68.49 Scores on a scale | Standard Deviation 20.217 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Mental Health at week 144 | 50.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Role Physical at week 144 | 25.00 Scores on a scale | — |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Physical Function at week 24 | 55.28 Scores on a scale | Standard Deviation 25.615 |
| Otilimab 150 mg | Absolute Values SF-36 Domain Scores | Vitality at week 24 | 55.18 Scores on a scale | Standard Deviation 20.593 |
Secondary
Absolute Values SF-36 Physical Component Scores (PCS)
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 96 | 39.18 T-Score | Standard Deviation 9.28 |
| Otilimab 90 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 48 | 40.17 T-Score | Standard Deviation 8.586 |
| Otilimab 90 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 24 | 41.19 T-Score | Standard Deviation 8.173 |
| Otilimab 150 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 144 | 35.03 T-Score | — |
| Otilimab 150 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 48 | 40.13 T-Score | Standard Deviation 8.271 |
| Otilimab 150 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 24 | 40.67 T-Score | Standard Deviation 8.232 |
| Otilimab 150 mg | Absolute Values SF-36 Physical Component Scores (PCS) | Week 96 | 38.86 T-Score | Standard Deviation 8.879 |
Secondary
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)
SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Otilimab 90 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 96 | 48.66 T-score | Standard Deviation 11.483 |
| Otilimab 90 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 48 | 49.54 T-score | Standard Deviation 10.577 |
| Otilimab 90 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 24 | 49.14 T-score | Standard Deviation 10.386 |
| Otilimab 150 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 144 | 42.55 T-score | — |
| Otilimab 150 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 48 | 49.70 T-score | Standard Deviation 10.557 |
| Otilimab 150 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 24 | 49.44 T-score | Standard Deviation 10.384 |
| Otilimab 150 mg | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | Week 96 | 49.75 T-score | Standard Deviation 11.351 |
Secondary
Number of Participants With Anti-GSK3196165 Antibodies
Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA
Time frame: Week 120
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Otilimab 90 mg | Number of Participants With Anti-GSK3196165 Antibodies | 11 Participants |
| Otilimab 150 mg | Number of Participants With Anti-GSK3196165 Antibodies | 10 Participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144
Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) \<= 1, Swollen Joint Count 66 (SJC66) \<= 1, high sensitivity C-reactive Protein (hsCRP) \<= 1mg/dl and patient's global assessment of disease activity (PtGA) \<= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI \<= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otilimab 90 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 96 | 8.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 48 | 8.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 24 | 7.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 144 | 0.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 48 | 4.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 24 | 6.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR, Week 96 | 9.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score \<=2.8. Percentage values are rounded off.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otilimab 90 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 96 | 13.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 48 | 12.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 24 | 11.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 144 | 0.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 48 | 9.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 24 | 10.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Week 96 | 9.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144
Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score \<=10. Percentage values are rounded off.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the intent to treat (ITT) set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otilimab 90 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 96 | 40.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 48 | 44.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 24 | 47.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 144 | 0.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 48 | 47.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 24 | 46.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Week 96 | 47.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144
The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (\<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.
Time frame: Week 24, 48, 96 and 144
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 96 | 26.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 48 | 25.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 24 | 26.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 144 | 0.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 48 | 25.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 24 | 25.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | Week 96 | 28.0 Percentage of participants |
Secondary
Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132
The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR \<2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.
Time frame: Week 24, 48, 96 and 132
Population: The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 24 | 15.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 48 | 14.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 96 | 16.0 Percentage of participants |
| Otilimab 90 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 132 | 0.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 132 | 33.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 24 | 14.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 96 | 12.0 Percentage of participants |
| Otilimab 150 mg | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | Week 48 | 13.0 Percentage of participants |