Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, Sirukumab, CNTO 136, CNTO136ARA3002, SIRROUND-D, CNTO136ARA3003, SIRROUND-T, SIRROUND-LTE
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
Detailed description
This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two groups of participants at the same time (parallel-group study). The maximum duration of participation in this study is 208 weeks, followed by approximately 16 weeks of safety and efficacy follow-up after the administration of the final study agent injection of sirukumab. Participant safety will be monitored throughout the study.
Interventions
DRUGSirukumab 100 mg
Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
DRUGSirukumab 50 mg
Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
DRUGPlacebo
Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
Sponsors
GlaxoSmithKline
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003 * Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study
Exclusion criteria
* Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003 * Is pregnant * Has active diverticulitis * Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) | From baseline of this LTE study up to 4.3 years | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | From baseline of this LTE study up to 4.3 years | MACE was defined as a composite of Myocardial Infarction (MI), stroke, death, hospitalization for unstable angina, and hospitalization for Transient Ischemic Attack (TIA). Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. |
| Percentage of Participants With Malignancies | From baseline of this LTE study up to 4.3 years | Percentage of participants with one or more malignancy was reported. |
| Percentage of Participants With Serious Infections | From baseline of this LTE study up to 4.3 years | Percentage of participants with one or more serious infections was reported. |
| Percentage of Participants With Gastrointestinal (GI) Perforations | From baseline of this LTE study up to 4.3 years | Percentage of participants with one or more GI perforations was reported. GI perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder. |
| Percentage of Participants With Hepatobiliary Abnormalities | From baseline of this LTE study up to 4.3 years | Percentage of participants with hepatobiliary abnormalities was reported. |
| Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events | From baseline of this LTE study up to 4.3 years | Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with normal HDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal HDL value was defined as HDL value \< 40 mg/dL. |
| Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with normal triglyceride value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal triglyceride value was defined as triglyceride value \> 250 mg/dL. |
| Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | ACR 50 response is greater than or equal to (\>=) 50 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and \>= 50% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), Participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received. |
| Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) \<=1; swollen joint count (66 joints) \<=1; CRP \<=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) \<=1 on a 0 (very well ) to 10 (extremely bad) scale. Higher scores indicates worst health condition. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received. |
| Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with toxicity grade 4 decrease in neutrophils was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decrease in neutrophils less than (\<) 500 per Cubic Millimeter (mm\^3) or \< 0.5 \* 10\^9 per liter. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received. |
| Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of \<= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 \[0 =very well to 10 = very poor\]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 \[0=no arthritis to 10=extremely active arthritis\]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received. |
| Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received. |
| Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260 | The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\<) 2.6 at any study visit. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received. |
| Percentage of Participants With Toxicity Grade 4 Decrease in Platelets | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with toxicity grade 4 decrease in platelets was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decreased in platelets \<25000/mm\^3 or \< 25.0 \* 10\^9 per liter. |
| Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with Alanine Aminotranserase (ALT) \>= 3\*Upper Limit of Normal (ULN), ALT \>= 5\*ULN or ALT \>= 8\*ULN was reported. |
| Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with Aspartate Aminotransferase (AST) \>= 3\*ULN, AST \>= 5\*ULN and AST \>= 8\*ULN was reported. |
| Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with either ALT \>= 3\*ULN or AST \>= 3\*ULN and total bilirubin \>= 2\*ULN was reported. |
| Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with normal total cholesterol value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal total cholesterol value was defined as total cholesterol value more than (\>) 200 milligrams per deciliter (mg/dL). |
| Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | From baseline of primary studies through end of this LTE study (Approximately 5.3 years) | Percentage of participants with normal LDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal LDL value was defined as LDL value \> 130 mg/dL. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, France, Germany, Japan, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants who completed participation in studies CNTO136ARA3002 (NCT01604343) and CNTO136ARA3003 (NCT01606761) and consented to participate in extension study were enrolled in this study.
Pre-assignment details
Data in the participant flow section is reported for treatment discontinuation.
Participants by arm
| Arm | Count |
|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO Participants initially randomized to placebo, then at early escape (EE), late escape (LE), or cross over (CO) randomized to sirukumab 50 mg every 4 weeks (q4w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen (sirukumab 50 mg q4w) upon entering this long-term extension (LTE) study. | 305 |
| Placebo to 100 mg q2w Due to EE/LE/CO Participants initially randomized to placebo, then at EE, LE, or CO randomized to sirukumab 100 mg every two weeks (q2w) during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study. | 291 |
| Sirukumab 50 mg q4w Participants initially randomized to sirukumab 50 mg q4w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study. | 606 |
| Sirukumab 100 mg q2w Participants initially randomized to sirukumab 100 mg q2w during the primary studies CNTO136ARA3002 and CNTO136ARA3003, and then continued to receive the same regimen upon entering this LTE study. | 618 |
| Total | 1,820 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 31 | 31 | 55 | 65 |
| Overall Study | Death | 4 | 6 | 11 | 6 |
| Overall Study | Lack of Efficacy | 14 | 9 | 40 | 25 |
| Overall Study | Lost to Follow-up | 6 | 2 | 4 | 8 |
| Overall Study | Noncompliance With Study Drug | 0 | 1 | 4 | 1 |
| Overall Study | Other | 227 | 225 | 447 | 469 |
| Overall Study | Physician Decision | 6 | 1 | 6 | 8 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 11 | 13 | 28 | 26 |
Baseline characteristics
| Characteristic | Sirukumab 100 mg q2w | Total | Placebo to 100 mg q2w Due to EE/LE/CO | Sirukumab 50 mg q4w | Placebo to 50 mg q4w Due to EE/LE/CO |
|---|---|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 11.29 | 53.4 years STANDARD_DEVIATION 11.51 | 53.1 years STANDARD_DEVIATION 11.75 | 53.1 years STANDARD_DEVIATION 11.43 | 54 years STANDARD_DEVIATION 11.92 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 11 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 110 Participants | 309 Participants | 47 Participants | 102 Participants | 50 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants | 69 Participants | 15 Participants | 21 Participants | 10 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 4 Participants | 12 Participants | 2 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 31 Participants | 97 Participants | 15 Participants | 40 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 443 Participants | 1318 Participants | 211 Participants | 433 Participants | 231 Participants |
| Region of Enrollment Argentina | 2 Participants | 15 Participants | 5 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Australia | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Austria | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Belgium | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Bulgaria | 3 Participants | 9 Participants | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment Canada | 3 Participants | 7 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Chile | 18 Participants | 50 Participants | 7 Participants | 14 Participants | 11 Participants |
| Region of Enrollment Colombia | 11 Participants | 29 Participants | 6 Participants | 10 Participants | 2 Participants |
| Region of Enrollment Croatia | 2 Participants | 8 Participants | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment France | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Germany | 5 Participants | 20 Participants | 3 Participants | 10 Participants | 2 Participants |
| Region of Enrollment Italy | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Japan | 78 Participants | 224 Participants | 36 Participants | 74 Participants | 36 Participants |
| Region of Enrollment Korea, Republic Of | 23 Participants | 48 Participants | 5 Participants | 14 Participants | 6 Participants |
| Region of Enrollment Lithuania | 32 Participants | 81 Participants | 10 Participants | 26 Participants | 13 Participants |
| Region of Enrollment Malaysia | 1 Participants | 5 Participants | 0 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Mexico | 40 Participants | 112 Participants | 16 Participants | 39 Participants | 17 Participants |
| Region of Enrollment Netherlands | 1 Participants | 5 Participants | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Poland | 62 Participants | 196 Participants | 31 Participants | 67 Participants | 36 Participants |
| Region of Enrollment Portugal | 4 Participants | 10 Participants | 0 Participants | 3 Participants | 3 Participants |
| Region of Enrollment Puerto Rico | 0 Participants | 4 Participants | 0 Participants | 3 Participants | 1 Participants |
| Region of Enrollment Romania | 4 Participants | 8 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Russia | 72 Participants | 198 Participants | 29 Participants | 63 Participants | 34 Participants |
| Region of Enrollment Serbia | 36 Participants | 118 Participants | 23 Participants | 38 Participants | 21 Participants |
| Region of Enrollment South Africa | 20 Participants | 71 Participants | 16 Participants | 22 Participants | 13 Participants |
| Region of Enrollment Spain | 4 Participants | 14 Participants | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Taiwan, Province Of China | 4 Participants | 27 Participants | 6 Participants | 12 Participants | 5 Participants |
| Region of Enrollment Ukraine | 41 Participants | 101 Participants | 13 Participants | 31 Participants | 16 Participants |
| Region of Enrollment United Kingdom | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 149 Participants | 449 Participants | 73 Participants | 156 Participants | 71 Participants |
| Sex: Female, Male Female | 503 Participants | 1454 Participants | 231 Participants | 479 Participants | 241 Participants |
| Sex: Female, Male Male | 115 Participants | 366 Participants | 60 Participants | 127 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 305 | 7 / 291 | 13 / 605 | 8 / 619 |
| other Total, other adverse events | 139 / 305 | 135 / 291 | 268 / 605 | 281 / 619 |
| serious Total, serious adverse events | 65 / 305 | 81 / 291 | 160 / 605 | 143 / 619 |
Outcome results
Primary
Percentage of Participants With Gastrointestinal (GI) Perforations
Percentage of participants with one or more GI perforations was reported. GI perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Gastrointestinal (GI) Perforations | 0.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Gastrointestinal (GI) Perforations | 1.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Gastrointestinal (GI) Perforations | 0.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Gastrointestinal (GI) Perforations | 0.5 Percentage of participants |
Primary
Percentage of Participants With Hepatobiliary Abnormalities
Percentage of participants with hepatobiliary abnormalities was reported.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Hepatobiliary Abnormalities | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Hepatobiliary Abnormalities | 0.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Hepatobiliary Abnormalities | 0.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Hepatobiliary Abnormalities | 0.2 Percentage of participants |
Primary
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
MACE was defined as a composite of Myocardial Infarction (MI), stroke, death, hospitalization for unstable angina, and hospitalization for Transient Ischemic Attack (TIA). Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | 2.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | 0.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | 2.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | 1.1 Percentage of participants |
Primary
Percentage of Participants With Malignancies
Percentage of participants with one or more malignancy was reported.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Malignancies | 1.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Malignancies | 3.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Malignancies | 1.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Malignancies | 1.8 Percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Serious Adverse Events (SAEs) | 21.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Serious Adverse Events (SAEs) | 27.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Serious Adverse Events (SAEs) | 26.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Serious Adverse Events (SAEs) | 23.1 Percentage of participants |
Primary
Percentage of Participants With Serious Infections
Percentage of participants with one or more serious infections was reported.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Serious Infections | 7.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Serious Infections | 12.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Serious Infections | 10.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Serious Infections | 10.7 Percentage of participants |
Primary
Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events
Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.
Time frame: From baseline of this LTE study up to 4.3 years
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events | 0.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events | 0.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events | 0.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events | 0.3 Percentage of participants |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260
The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.
Time frame: Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 156 | -26.53 Units on a scale | Standard Deviation 14.998 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 132 | -27.24 Units on a scale | Standard Deviation 12.671 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 76 | -27.49 Units on a scale | Standard Deviation 12.763 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 24 | -15.08 Units on a scale | Standard Deviation 11.697 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 128 | -24.55 Units on a scale | Standard Deviation 13.797 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 104 | -26.85 Units on a scale | Standard Deviation 13.261 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 80 | -23.31 Units on a scale | Standard Deviation 14.84 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 36 | -21.49 Units on a scale | Standard Deviation 12.343 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 20 | -7.19 Units on a scale | Standard Deviation 12.051 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 260 | -34.70 Units on a scale | Standard Deviation 4.776 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 44 | -22.80 Units on a scale | Standard Deviation 14.39 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 32 | -20.36 Units on a scale | Standard Deviation 14.238 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 232 | -26.61 Units on a scale | Standard Deviation 13.42 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 48 | -23.74 Units on a scale | Standard Deviation 13.685 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 28 | -19.69 Units on a scale | Standard Deviation 13.518 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 208 | -27.54 Units on a scale | Standard Deviation 12.054 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 180 | -27.21 Units on a scale | Standard Deviation 14.37 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 52 | -24.09 Units on a scale | Standard Deviation 13.629 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 40 | -22.67 Units on a scale | Standard Deviation 13.374 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 76 | -25.91 Units on a scale | Standard Deviation 13.537 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 32 | -20.69 Units on a scale | Standard Deviation 12.754 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 36 | -22.53 Units on a scale | Standard Deviation 12.609 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 40 | -22.36 Units on a scale | Standard Deviation 13.208 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 44 | -22.31 Units on a scale | Standard Deviation 13.062 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 48 | -22.56 Units on a scale | Standard Deviation 13.229 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 52 | -23.17 Units on a scale | Standard Deviation 13.28 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 80 | -22.67 Units on a scale | Standard Deviation 12.546 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 104 | -26.08 Units on a scale | Standard Deviation 12.872 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 128 | -25.12 Units on a scale | Standard Deviation 12.102 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 132 | -26.62 Units on a scale | Standard Deviation 13.994 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 156 | -26.85 Units on a scale | Standard Deviation 13.999 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 180 | -27.07 Units on a scale | Standard Deviation 13.969 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 208 | -27.06 Units on a scale | Standard Deviation 15.579 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 232 | -26.25 Units on a scale | Standard Deviation 17.509 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 260 | -26.60 Units on a scale | Standard Deviation 20.789 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 20 | -7.01 Units on a scale | Standard Deviation 11.666 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 24 | -12.78 Units on a scale | Standard Deviation 11.654 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 28 | -19.58 Units on a scale | Standard Deviation 12.578 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 28 | -21.85 Units on a scale | Standard Deviation 14 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 6 | -13.79 Units on a scale | Standard Deviation 12.198 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 208 | -27.01 Units on a scale | Standard Deviation 12.968 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 8 | -15.56 Units on a scale | Standard Deviation 12.736 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 132 | -26.06 Units on a scale | Standard Deviation 13.661 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 12 | -17.79 Units on a scale | Standard Deviation 13.955 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 44 | -23.19 Units on a scale | Standard Deviation 14.214 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 16 | -18.50 Units on a scale | Standard Deviation 13.956 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 36 | -22.64 Units on a scale | Standard Deviation 13.75 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 18 | -18.93 Units on a scale | Standard Deviation 14.459 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 232 | -26.06 Units on a scale | Standard Deviation 16.858 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 40 | -23.09 Units on a scale | Standard Deviation 13.89 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 156 | -25.59 Units on a scale | Standard Deviation 14.641 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 20 | -20.72 Units on a scale | Standard Deviation 14.077 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 180 | -26.95 Units on a scale | Standard Deviation 13.671 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 80 | -23.27 Units on a scale | Standard Deviation 15.372 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 260 | -20.73 Units on a scale | Standard Deviation 11.983 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 52 | -24.05 Units on a scale | Standard Deviation 13.93 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 32 | -22.37 Units on a scale | Standard Deviation 13.935 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 104 | -25.75 Units on a scale | Standard Deviation 13.931 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 2 | -6.54 Units on a scale | Standard Deviation 9.464 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 76 | -25.98 Units on a scale | Standard Deviation 14.077 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 24 | -21.20 Units on a scale | Standard Deviation 13.625 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 128 | -25.06 Units on a scale | Standard Deviation 15.496 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 48 | -23.22 Units on a scale | Standard Deviation 14.281 |
| Sirukumab 50 mg q4w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 4 | -11.09 Units on a scale | Standard Deviation 11.257 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 12 | -17.89 Units on a scale | Standard Deviation 13.636 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 132 | -24.61 Units on a scale | Standard Deviation 13.391 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 36 | -22.79 Units on a scale | Standard Deviation 13.22 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 156 | -25.60 Units on a scale | Standard Deviation 13.196 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 48 | -23.20 Units on a scale | Standard Deviation 13.008 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 44 | 23.04 Units on a scale | Standard Deviation 13.484 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 180 | -25.88 Units on a scale | Standard Deviation 13.91 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 208 | -27.12 Units on a scale | Standard Deviation 13.008 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 232 | -27.23 Units on a scale | Standard Deviation 14.636 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 40 | -22.49 Units on a scale | Standard Deviation 14.268 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 260 | -19.03 Units on a scale | Standard Deviation 18.823 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 2 | -6.10 Units on a scale | Standard Deviation 9.295 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 4 | -10.73 Units on a scale | Standard Deviation 11.469 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 6 | -14.05 Units on a scale | Standard Deviation 11.613 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 8 | -15.74 Units on a scale | Standard Deviation 12.333 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 24 | -21.06 Units on a scale | Standard Deviation 13.888 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 16 | -18.65 Units on a scale | Standard Deviation 13.584 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 18 | -18.40 Units on a scale | Standard Deviation 13.524 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 32 | -22.17 Units on a scale | Standard Deviation 13.462 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 20 | -19.96 Units on a scale | Standard Deviation 13.678 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 80 | -23.70 Units on a scale | Standard Deviation 14.755 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 76 | -24.83 Units on a scale | Standard Deviation 12.664 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 28 | -21.33 Units on a scale | Standard Deviation 13.655 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 104 | -25.60 Units on a scale | Standard Deviation 13.596 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 128 | -26.14 Units on a scale | Standard Deviation 14.81 |
| Sirukumab 100 mg q2w | Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260 | Change at Week 52 | -23.61 Units on a scale | Standard Deviation 13.376 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260
The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
Time frame: Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after the escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies number of participants analyzed at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 180 | -0.4505 Units on Scale | Standard Deviation 0.7024 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 20 | -0.1363 Units on Scale | Standard Deviation 0.4947 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 40 | -0.4138 Units on Scale | Standard Deviation 0.5778 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 232 | -0.4191 Units on Scale | Standard Deviation 0.741 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 52 | -0.4228 Units on Scale | Standard Deviation 0.5752 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 28 | -0.3722 Units on Scale | Standard Deviation 0.5683 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 48 | -0.4392 Units on Scale | Standard Deviation 0.5911 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 80 | -0.2074 Units on Scale | Standard Deviation 0.5333 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 44 | -0.4231 Units on Scale | Standard Deviation 0.5809 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 156 | -0.4614 Units on Scale | Standard Deviation 0.661 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 104 | -0.4778 Units on Scale | Standard Deviation 0.6569 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 260 | -0.5417 Units on Scale | Standard Deviation 0.8323 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 128 | -0.2664 Units on Scale | Standard Deviation 0.5963 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 132 | -0.4831 Units on Scale | Standard Deviation 0.6979 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 36 | -0.3862 Units on Scale | Standard Deviation 0.5474 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 208 | -0.4622 Units on Scale | Standard Deviation 0.6898 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 32 | -0.3847 Units on Scale | Standard Deviation 0.5651 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 24 | -0.3192 Units on Scale | Standard Deviation 0.5279 |
| Placebo to 50 mg q4w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 76 | -0.5816 Units on Scale | Standard Deviation 0.6313 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 132 | -0.4815 Units on Scale | Standard Deviation 0.6656 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 44 | -0.4461 Units on Scale | Standard Deviation 0.5206 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 104 | -0.5107 Units on Scale | Standard Deviation 0.5958 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 36 | -0.4339 Units on Scale | Standard Deviation 0.5432 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 180 | -0.4957 Units on Scale | Standard Deviation 0.5969 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 208 | -0.4973 Units on Scale | Standard Deviation 0.6032 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 232 | -0.4655 Units on Scale | Standard Deviation 0.6477 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 260 | -0.3750 Units on Scale | Standard Deviation 1.0607 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 40 | -0.4509 Units on Scale | Standard Deviation 0.4988 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 48 | -0.4567 Units on Scale | Standard Deviation 0.5254 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 52 | -0.4609 Units on Scale | Standard Deviation 0.5455 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 76 | -0.5351 Units on Scale | Standard Deviation 0.5605 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 80 | -0.3980 Units on Scale | Standard Deviation 0.5579 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 24 | -0.3267 Units on Scale | Standard Deviation 0.4739 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 128 | -0.4476 Units on Scale | Standard Deviation 0.5263 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 156 | -0.4984 Units on Scale | Standard Deviation 0.652 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 28 | -0.3836 Units on Scale | Standard Deviation 0.4741 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 20 | -0.2005 Units on Scale | Standard Deviation 0.4987 |
| Placebo to 100 mg q2w Due to EE/LE/CO | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 32 | -0.4015 Units on Scale | Standard Deviation 0.5532 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 16 | -0.3991 Units on Scale | Standard Deviation 0.5611 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 32 | -0.4769 Units on Scale | Standard Deviation 0.588 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 20 | -0.4425 Units on Scale | Standard Deviation 0.5826 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 12 | -0.3866 Units on Scale | Standard Deviation 0.5421 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 180 | -0.5072 Units on Scale | Standard Deviation 0.6492 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 104 | -0.5153 Units on Scale | Standard Deviation 0.6094 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 260 | -0.2083 Units on Scale | Standard Deviation 0.6702 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 28 | -0.4736 Units on Scale | Standard Deviation 0.5696 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 128 | -0.3615 Units on Scale | Standard Deviation 0.6227 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 24 | -0.4506 Units on Scale | Standard Deviation 0.5665 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 132 | -0.5045 Units on Scale | Standard Deviation 0.6542 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 80 | -0.3834 Units on Scale | Standard Deviation 0.5685 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 6 | -0.3112 Units on Scale | Standard Deviation 0.4944 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 156 | -0.4719 Units on Scale | Standard Deviation 0.6604 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 76 | -0.5628 Units on Scale | Standard Deviation 0.6089 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 48 | -0.4890 Units on Scale | Standard Deviation 0.6242 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 8 | -0.3499 Units on Scale | Standard Deviation 0.5077 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 40 | -0.4850 Units on Scale | Standard Deviation 0.5894 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 44 | -0.4906 Units on Scale | Standard Deviation 0.6088 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 18 | -0.4365 Units on Scale | Standard Deviation 0.5476 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 2 | -0.1136 Units on Scale | Standard Deviation 0.3455 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 36 | -0.4850 Units on Scale | Standard Deviation 0.5764 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 4 | -0.2307 Units on Scale | Standard Deviation 0.4173 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 232 | -0.5877 Units on Scale | Standard Deviation 0.8312 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 52 | -0.4946 Units on Scale | Standard Deviation 0.6021 |
| Sirukumab 50 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 208 | -0.5031 Units on Scale | Standard Deviation 0.6701 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 260 | -0.5000 Units on Scale | Standard Deviation 0.4507 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 4 | -0.2417 Units on Scale | Standard Deviation 0.4034 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 6 | -0.3683 Units on Scale | Standard Deviation 0.4823 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 8 | -0.3914 Units on Scale | Standard Deviation 0.5022 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 16 | -0.4414 Units on Scale | Standard Deviation 0.543 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 18 | -0.4621 Units on Scale | Standard Deviation 0.5325 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 32 | -0.5307 Units on Scale | Standard Deviation 0.574 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 36 | -0.5176 Units on Scale | Standard Deviation 0.5688 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 40 | -0.5039 Units on Scale | Standard Deviation 0.5735 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 44 | -0.5297 Units on Scale | Standard Deviation 0.5777 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 48 | -0.5470 Units on Scale | Standard Deviation 0.5942 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 52 | -0.5374 Units on Scale | Standard Deviation 0.5881 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 76 | -0.6128 Units on Scale | Standard Deviation 0.5992 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 80 | -0.4211 Units on Scale | Standard Deviation 0.5626 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 104 | -0.5579 Units on Scale | Standard Deviation 0.5913 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 156 | -0.4998 Units on Scale | Standard Deviation 0.6109 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 232 | -0.6069 Units on Scale | Standard Deviation 0.6262 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 2 | -0.1230 Units on Scale | Standard Deviation 0.3741 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 12 | -0.4121 Units on Scale | Standard Deviation 0.527 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 20 | -0.4920 Units on Scale | Standard Deviation 0.5582 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 24 | -0.4876 Units on Scale | Standard Deviation 0.5622 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 28 | -0.4912 Units on Scale | Standard Deviation 0.5626 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 128 | -0.4506 Units on Scale | Standard Deviation 0.5527 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 132 | -0.5310 Units on Scale | Standard Deviation 0.624 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 180 | -0.5258 Units on Scale | Standard Deviation 0.6167 |
| Sirukumab 100 mg q2w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260 | Change at Week 208 | -0.5588 Units on Scale | Standard Deviation 0.6023 |
Secondary
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260
ACR 50 response is greater than or equal to (\>=) 50 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and \>= 50% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), Participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
Time frame: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 128 | 35.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 20 | 4.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 104 | 48.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 28 | 24.4 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 76 | 56.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 48 | 43.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 156 | 48.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 32 | 30.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 232 | 48.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 52 | 41.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 80 | 38.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 36 | 29.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 180 | 53.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 208 | 50.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 132 | 51.1 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 40 | 38.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 24 | 17.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 260 | 66.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 44 | 40.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 128 | 43.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 44 | 33.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 180 | 54.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 48 | 27.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 104 | 46.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 52 | 34.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 20 | 3.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 76 | 49.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 80 | 26.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 24 | 10.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 260 | 50.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 156 | 56.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 28 | 23.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 208 | 50.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 32 | 30.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 232 | 57.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 132 | 46.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 36 | 33.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 40 | 34.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 80 | 38.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 4 | 9.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 6 | 16.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 8 | 21.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 12 | 27.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 16 | 31.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 18 | 33.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 20 | 36.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 24 | 35.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 28 | 40.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 32 | 40.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 36 | 42.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 40 | 42.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 44 | 43.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 48 | 44.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 52 | 43.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 76 | 52.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 2 | 2.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 104 | 50.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 128 | 42.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 132 | 50.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 156 | 50.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 180 | 54.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 208 | 50.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 232 | 51.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 260 | 60.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 6 | 14.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 128 | 46.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 36 | 43.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 32 | 42.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 260 | 25.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 132 | 53.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 28 | 39.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 24 | 37.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 232 | 57.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 156 | 52.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 20 | 38.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 18 | 32.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 4 | 9.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 180 | 56.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 16 | 29.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 12 | 29.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 2 | 2.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 76 | 56.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 208 | 59.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 80 | 44.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 52 | 44.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 48 | 44.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 8 | 20.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 104 | 53.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 44 | 44.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260 | At Week 40 | 42.2 Percentage of participants |
Secondary
Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN
Percentage of participants with Alanine Aminotranserase (ALT) \>= 3\*Upper Limit of Normal (ULN), ALT \>= 5\*ULN or ALT \>= 8\*ULN was reported.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 3 * ULN | 14.1 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 8 * ULN | 0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 5 * ULN | 2.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 3 * ULN | 14.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 8 * ULN | 0.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 5 * ULN | 2.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 5 * ULN | 2.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 3 * ULN | 15.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 8 * ULN | 0.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 3 * ULN | 17.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 8 * ULN | 0.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN | ALT >= 5 * ULN | 3.9 Percentage of participants |
Secondary
Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN
Percentage of participants with Aspartate Aminotransferase (AST) \>= 3\*ULN, AST \>= 5\*ULN and AST \>= 8\*ULN was reported.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 3 * ULN | 3.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 8 * ULN | 0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 5 * ULN | 0.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 3 * ULN | 6.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 8 * ULN | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 5 * ULN | 1.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 5 * ULN | 0.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 3 * ULN | 4.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 8 * ULN | 0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 3 * ULN | 7.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 8 * ULN | 0.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN | AST >= 5 * ULN | 1.1 Percentage of participants |
Secondary
Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260
Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) \<=1; swollen joint count (66 joints) \<=1; CRP \<=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) \<=1 on a 0 (very well ) to 10 (extremely bad) scale. Higher scores indicates worst health condition. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.
Time frame: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 6.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 2.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 2.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 4.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 2.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 11.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 4.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 4.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 2.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 12.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 10.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 6.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 9.4 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 11.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 9.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 0.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 12.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 8.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 11.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 2.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 11.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 7.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 6.6 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 4.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 13.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 8.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 4.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 17.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 6.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 0.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 6.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 8.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 10.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 7.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 18.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 14.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 11.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 18.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 2 | 0.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 4 | 0.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 6 | 0.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 8 | 1.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 12 | 3.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 16 | 3.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 18 | 4.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 4.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 5.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 6.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 4.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 7.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 7.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 7.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 9.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 9.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 10.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 7.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 12.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 10.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 10.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 10.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 5.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 9.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 7.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 18 | 5.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 16 | 5.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 11.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 9.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 12 | 4.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 8 | 2.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 10.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 6.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 6 | 1.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 4 | 0.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 19.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 10.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 2 | 0.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 9.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 9.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 13.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 9.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 7.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 6.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 8.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 9.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 8.1 Percentage of participants |
Secondary
Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260
The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\<) 2.6 at any study visit. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.
Time frame: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 76 | 44.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 44 | 34.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 260 | 66.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 32 | 24.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 52 | 30.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 208 | 55.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 20 | 1.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 156 | 43.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 24 | 7.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 104 | 44.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 28 | 17.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 180 | 48.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 80 | 38.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 48 | 33.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 132 | 41.4 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 232 | 59.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 36 | 21.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 128 | 43.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 40 | 29.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 180 | 48.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 24 | 7.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 40 | 32.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 208 | 54.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 104 | 47.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 32 | 24.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 80 | 39.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 36 | 30.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 44 | 30.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 48 | 31.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 52 | 32.6 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 76 | 44.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 156 | 47.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 28 | 20.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 260 | 100.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 132 | 47.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 232 | 52.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 20 | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 128 | 43.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 2 | 2.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 4 | 7.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 12 | 20.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 16 | 23.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 18 | 25.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 32 | 35.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 36 | 35.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 40 | 34.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 48 | 38.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 52 | 38.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 76 | 47.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 80 | 38.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 104 | 42.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 232 | 57.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 6 | 10.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 8 | 15.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 20 | 29.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 24 | 30.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 28 | 33.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 44 | 36.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 128 | 45.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 132 | 48.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 156 | 46.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 180 | 50.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 208 | 54.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 260 | 77.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 24 | 32.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 20 | 30.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 12 | 23.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 128 | 43.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 4 | 9.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 2 | 2.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 8 | 18.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 132 | 49.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 76 | 45.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 48 | 38.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 232 | 59.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 156 | 49.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 40 | 34.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 36 | 35.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 6 | 13.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 180 | 53.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 18 | 25.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 16 | 24.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 260 | 25.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 208 | 60.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 52 | 37.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 44 | 35.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 32 | 36.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 80 | 38.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 28 | 32.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260 | At Week 104 | 46.6 Percentage of participants |
Secondary
Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN
Percentage of participants with either ALT \>= 3\*ULN or AST \>= 3\*ULN and total bilirubin \>= 2\*ULN was reported.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN | 0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN | 0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN | 0.2 Percentage of participants |
Secondary
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260
HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
Time frame: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 180 | 61.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 48 | 61.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 104 | 64.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 128 | 51.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 80 | 40.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 28 | 58.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 232 | 67.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 76 | 70.4 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 52 | 60.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 36 | 61.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 32 | 59.4 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 24 | 54.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 40 | 61.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 156 | 62.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 20 | 40.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 260 | 66.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 44 | 62.6 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 132 | 65.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 208 | 65.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 260 | 50.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 28 | 61.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 40 | 67.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 44 | 65.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 48 | 65.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 76 | 69.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 80 | 58.6 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 104 | 68.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 128 | 64.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 132 | 63.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 156 | 64.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 180 | 69.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 208 | 69.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 232 | 69.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 20 | 45.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 24 | 54.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 32 | 59.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 36 | 64.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 52 | 65.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 44 | 65.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 20 | 64.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 260 | 44.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 18 | 63.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 180 | 66.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 24 | 64.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 132 | 66.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 2 | 36.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 36 | 67.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 208 | 71.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 128 | 54.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 4 | 48.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 32 | 65.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 76 | 68.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 6 | 56.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 16 | 62.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 8 | 58.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 80 | 58.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 12 | 60.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 52 | 65.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 104 | 66.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 232 | 65.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 48 | 65.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 156 | 65.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 40 | 65.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 28 | 66.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 24 | 67.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 132 | 69.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 44 | 67.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 180 | 72.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 16 | 63.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 208 | 72.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 232 | 72.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 40 | 66.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 260 | 66.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 2 | 36.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 6 | 57.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 12 | 62.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 18 | 66.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 156 | 66.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 20 | 67.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 36 | 67.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 28 | 66.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 32 | 68.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 8 | 62.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 76 | 73.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 48 | 70.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 4 | 51.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 80 | 62.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 104 | 68.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 52 | 68.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260 | At Week 128 | 61.1 Percentage of participants |
Secondary
Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Percentage of participants with normal HDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal HDL value was defined as HDL value \< 40 mg/dL.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study and had HDL baseline value within normal range.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 16.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 14.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 16.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 16.0 Percentage of participants |
Secondary
Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Percentage of participants with normal LDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal LDL value was defined as LDL value \> 130 mg/dL.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study and had LDL baseline value within normal range.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 70.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 67.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 69.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 70.8 Percentage of participants |
Secondary
Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Percentage of participants with normal total cholesterol value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal total cholesterol value was defined as total cholesterol value more than (\>) 200 milligrams per deciliter (mg/dL).
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study and had total cholesterol baseline value within normal range.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 86.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 81.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 82.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 87.2 Percentage of participants |
Secondary
Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline
Percentage of participants with normal triglyceride value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal triglyceride value was defined as triglyceride value \> 250 mg/dL.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study and had triglyceride baseline value within normal range.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 32.6 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 35.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 36.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline | 34.4 Percentage of participants |
Secondary
Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260
Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of \<= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 \[0 =very well to 10 = very poor\]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 \[0=no arthritis to 10=extremely active arthritis\]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.
Time frame: Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260
Population: Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 16.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 9.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 14.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 1.8 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 33.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 18.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 21.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 18.3 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 3.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 25.39 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 905 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 4.0 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 8.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 7.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 17.9 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 8.7 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 4.5 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 8.2 Percentage of participants |
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 10.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 13.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 10.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 8.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 7.1 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 18.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 15.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 1.9 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 20.2 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 11.0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 15.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 20.7 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 14.8 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 6.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 12.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 20.4 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 7.5 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 50.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 2 | 0.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 4 | 0.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 6 | 1.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 8 | 2.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 12 | 4.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 16 | 5.2 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 18 | 7.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 10.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 9.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 11.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 13.7 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 11.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 14.9 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 15.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 12.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 17.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 16.1 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 22.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 22.4 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 55.6 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 8.0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 9.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 16.8 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 20.5 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 27.3 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 17.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 76 | 14.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 16 | 8.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 260 | 0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 8 | 3.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 12 | 6.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 6 | 2.9 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 2 | 0.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 24 | 10.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 52 | 12.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 32 | 12.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 44 | 13.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 40 | 13.7 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 36 | 13.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 48 | 12.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 28 | 9.2 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 20 | 9.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 18 | 7.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 4 | 1.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 180 | 24.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 156 | 19.4 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 132 | 19.0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 80 | 11.1 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 208 | 30.3 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 128 | 13.6 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 232 | 29.8 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260 | At Week 104 | 19.8 Percentage of participants |
Secondary
Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils
Percentage of participants with toxicity grade 4 decrease in neutrophils was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decrease in neutrophils less than (\<) 500 per Cubic Millimeter (mm\^3) or \< 0.5 \* 10\^9 per liter.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils | 1.3 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils | 0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils | 0.5 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils | 0 Percentage of participants |
Secondary
Percentage of Participants With Toxicity Grade 4 Decrease in Platelets
Percentage of participants with toxicity grade 4 decrease in platelets was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decreased in platelets \<25000/mm\^3 or \< 25.0 \* 10\^9 per liter.
Time frame: From baseline of primary studies through end of this LTE study (Approximately 5.3 years)
Population: Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to 50 mg q4w Due to EE/LE/CO | Percentage of Participants With Toxicity Grade 4 Decrease in Platelets | 0 Percentage of participants |
| Placebo to 100 mg q2w Due to EE/LE/CO | Percentage of Participants With Toxicity Grade 4 Decrease in Platelets | 0 Percentage of participants |
| Sirukumab 50 mg q4w | Percentage of Participants With Toxicity Grade 4 Decrease in Platelets | 0 Percentage of participants |
| Sirukumab 100 mg q2w | Percentage of Participants With Toxicity Grade 4 Decrease in Platelets | 0 Percentage of participants |