Arthritis, Rheumatoid
Conditions
Keywords
Arthritis, Rheumatoid, Rheumatoid Arthritis, Active Rheumatoid Arthritis, CNTO 136, Interleukin-6, Anti-interleukin-6 monoclonal antibody, Methotrexate, Placebo
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.
Detailed description
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) study. This study will be conducted in 2 parts (Part A and Part B). Each part consists of 3 phases: screening (approximately 1 month prior to the start of study medication), treatment phase (Part A: 22 weeks and Part B: 24 weeks), and follow-up phase (approximately 4 months after the last administration of study medication). In Part A, participants will be randomly assigned to 2 groups to receive CNTO 136 100 mg and placebo for 22 weeks. All participants in Part A, will be crossed over at Week 12 from placebo to CNTO 136 (for Group 1) and from CNTO 136 to placebo (for Group 2). In Part B, participants will be randomly assigned to 5 groups to receive placebo and/or 1 of 3 doses of CNTO 136 (100mg, 50mg or 25mg) for 24 weeks. Participants in Part B, Group 1 will be crossed over at Week 12 from placebo to CNTO 136. All participants should be maintained on a stable dose of MTX for at least 6 weeks prior to the start of study medication through Week 24. Safety will be evaluated by the assessment of adverse events, vital signs, clinical findings, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be approximately 42 weeks.
Interventions
DRUGCNTO 136 100 mg
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
DRUGCNTO 136 50 mg
CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
DRUGCNTO 136 25 mg
CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
DRUGPlacebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
DRUGMethotrexate
Stable dose of methotrexate will be maintained through Week 24.
Sponsors
Centocor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with rheumatoid arthritis (RA) for at least 4 months prior to screening * Have been treated and having an inadequate response with the tolerated dose of methotrexate (MTX) (at least 15mg/week) for at least 4 months prior to screening. MTX doses of 10 or 12.5 mg/week are allowed if participant had intolerance of 15 mg/week * MTX route of administration and dose (not to exceed 25 mg/week) should be stable for at least 6 weeks prior to the start of the study medication * Have active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and baseline, and either anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive at screening * C-reactive protein greater than or equal to 1.0 mg/dL (10 mg/L) * Agree to use one of the contraception methods defined in the protocol
Exclusion criteria
* Have inflammatory diseases other than RA that might confound the evaluation of the benefit of CNTO 136 therapy in arthritis * Family history of/ have long QT syndrome; or a history of second or third-degree heart block * Received systemic immunosuppressives or disease modifying antirheumatic drug other than MTX, sulfasalazine, hydroxychloroquine or chloroquine within 4 weeks prior to the start of study medication * Received intra articular (into joints), intramuscular, or intravenous corticosteroids within 4 weeks prior to the start of study medication * Positive human immunodeficiency virus test, hepatitis B or hepatitis C * History of / have chronic or recurrent infectious disease, history of / active tuberculosis * Have serious infection within 2 months prior to start of study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) | Week 12 | An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), physician's global assessment of disease activity using VAS (the 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, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline, Week 12 | The 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. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline. |
| Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A) | Week 12 | An ACR 50 response is defined as \>= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP. |
| Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38 | Sirukumab Concentrations in serum were measured. |
| Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38 | Sirukumab Concentrations in serum were measured. |
| Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | Baseline, Week 2 | Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement. |
Countries
Hungary, Japan, Mexico, Poland, Russia, South Korea, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: Placebo Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. | 19 |
| Part A: Sirukumab 100 mg q2 Weeks Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22. | 17 |
| Part B: Placebo Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. | 30 |
| Part B: Sirukumab 100 mg q2 Weeks Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | 30 |
| Part B: Sirukumab 100 mg q4 Weeks Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | 30 |
| Part B: Sirukumab 50 mg q4 Weeks Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | 30 |
| Part B: Sirukumab 25 mg q4 Weeks Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | 31 |
| Total | 187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Prior to Week 12 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Prior to Week 12 | Other | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Prior to Week 12 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 1 | 0 |
| Week 12 to End of Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Week 12 to End of Study | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Week 12 to End of Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Week 12 to End of Study | Other | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Week 12 to End of Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part A: Placebo | Part A: Sirukumab 100 mg q2 Weeks | Part B: Placebo | Part B: Sirukumab 100 mg q2 Weeks | Part B: Sirukumab 100 mg q4 Weeks | Part B: Sirukumab 50 mg q4 Weeks | Part B: Sirukumab 25 mg q4 Weeks | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 10.24 | 50.1 years STANDARD_DEVIATION 10.72 | 54.1 years STANDARD_DEVIATION 12.72 | 53.8 years STANDARD_DEVIATION 13.02 | 52 years STANDARD_DEVIATION 11 | 50.9 years STANDARD_DEVIATION 10.29 | 52.8 years STANDARD_DEVIATION 9.41 | 51.8 years STANDARD_DEVIATION 11.26 |
| Region of Enrollment Hungary | 0 Participants | 0 Participants | 2 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 17 Participants |
| Region of Enrollment Japan | 0 Participants | 0 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 27 Participants |
| Region of Enrollment Mexico | 0 Participants | 0 Participants | 5 Participants | 3 Participants | 4 Participants | 5 Participants | 6 Participants | 23 Participants |
| Region of Enrollment Poland | 13 Participants | 12 Participants | 9 Participants | 10 Participants | 6 Participants | 5 Participants | 7 Participants | 62 Participants |
| Region of Enrollment Republic of Korea | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Region of Enrollment Russian Federation | 0 Participants | 0 Participants | 9 Participants | 6 Participants | 10 Participants | 9 Participants | 7 Participants | 41 Participants |
| Region of Enrollment United States | 6 Participants | 5 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 12 Participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 25 Participants | 27 Participants | 27 Participants | 26 Participants | 23 Participants | 153 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 8 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 19 | 18 / 18 | 12 / 17 | 10 / 16 | 15 / 30 | 11 / 26 | 20 / 30 | 18 / 30 | 25 / 30 | 23 / 31 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 | 1 / 17 | 0 / 16 | 4 / 30 | 2 / 26 | 2 / 30 | 5 / 30 | 1 / 30 | 3 / 31 |
Outcome results
Primary
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)
An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), physician's global assessment of disease activity using VAS (the 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, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).
Time frame: Week 12
Population: Population analyzed included all randomized participants in Part B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B: Placebo | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) | 3.3 Percentage of Participants |
| Part B: Sirukumab 100 mg q2 Weeks | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) | 26.7 Percentage of Participants |
| Part B: Sirukumab 100 mg q4 Weeks | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) | 23.3 Percentage of Participants |
| Part B: Sirukumab 50 mg q4 Weeks | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) | 26.7 Percentage of Participants |
| Part B: Sirukumab 25 mg q4 Weeks | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) | 19.4 Percentage of Participants |
p-value: 0.026Cochran-Mantel-Haenszel
p-value: 0.052Cochran-Mantel-Haenszel
p-value: 0.026Cochran-Mantel-Haenszel
p-value: 0.104Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)
The 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. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.
Time frame: Baseline, Week 12
Population: Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 6.341 Units on a Scale | Standard Deviation 0.9034 |
| Part B: Placebo | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -0.619 Units on a Scale | Standard Deviation 0.8541 |
| Part B: Sirukumab 100 mg q2 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 5.919 Units on a Scale | Standard Deviation 0.9676 |
| Part B: Sirukumab 100 mg q2 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -2.075 Units on a Scale | Standard Deviation 0.7979 |
| Part B: Sirukumab 100 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 5.908 Units on a Scale | Standard Deviation 0.7332 |
| Part B: Sirukumab 100 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -1.073 Units on a Scale | Standard Deviation 0.9766 |
| Part B: Sirukumab 50 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 5.755 Units on a Scale | Standard Deviation 0.9706 |
| Part B: Sirukumab 50 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -2.248 Units on a Scale | Standard Deviation 1.205 |
| Part B: Sirukumab 25 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 6.190 Units on a Scale | Standard Deviation 0.6829 |
| Part B: Sirukumab 25 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -2.011 Units on a Scale | Standard Deviation 0.8843 |
| Part B: Sirukumab 50 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 6.051 Units on a Scale | Standard Deviation 0.8791 |
| Part B: Sirukumab 50 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -2.198 Units on a Scale | Standard Deviation 0.855 |
| Part B: Sirukumab 25 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Baseline | 5.688 Units on a Scale | Standard Deviation 0.9529 |
| Part B: Sirukumab 25 mg q4 Weeks | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) | Change at Week 12 | -1.964 Units on a Scale | Standard Deviation 0.9532 |
p-value: <0.001Van Der Waerden ANOVA
p-value: <0.001Van Der Waerden ANOVA
p-value: <0.001Van Der Waerden ANOVA
p-value: <0.001Van Der Waerden ANOVA
p-value: <0.001Van Der Waerden ANOVA
Secondary
Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)
An ACR 50 response is defined as \>= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and \>= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \[0 = very well to 10 = very poor\]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, \[0=no arthritis activity to 10=extremely active arthritis\]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.
Time frame: Week 12
Population: Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B: Placebo | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A) | 5.9 Percentage of Participants |
| Part B: Sirukumab 100 mg q2 Weeks | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A) | 28.6 Percentage of Participants |
p-value: 0.148Cochran-Mantel-Haenszel
Secondary
Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)
Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.
Time frame: Baseline, Week 2
Population: Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part B: Placebo | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | -49.31 Percent change | Standard Deviation 246.04 |
| Part B: Sirukumab 100 mg q2 Weeks | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | 81.46 Percent change | Standard Deviation 25 |
| Part B: Sirukumab 100 mg q4 Weeks | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | 88.53 Percent change | Standard Deviation 12.675 |
| Part B: Sirukumab 50 mg q4 Weeks | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | 85.42 Percent change | Standard Deviation 18.242 |
| Part B: Sirukumab 25 mg q4 Weeks | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | 81.22 Percent change | Standard Deviation 24.484 |
| Part B: Sirukumab 50 mg q4 Weeks | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | 19.97 Percent change | Standard Deviation 41.232 |
| Part B: Sirukumab 25 mg q4 Weeks | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) | 91.19 Percent change | Standard Deviation 4.812 |
Secondary
Serum Sirukumab Concentrations Through Week 38 (Part A)
Sirukumab Concentrations in serum were measured.
Time frame: Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38
Population: Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 0 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 2 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 5 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 8 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 11 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 2 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 4 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 6 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 8 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 10 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 10 Day 4 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 10 Day 7 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 12 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 14 | 4.78 Microgram per milliliter | Standard Deviation 1.779 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 18 | 8.52 Microgram per milliliter | Standard Deviation 4.338 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 22 | 10.79 Microgram per milliliter | Standard Deviation 5.83 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 24 | 11.37 Microgram per milliliter | Standard Deviation 6.177 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 38 | 0.41 Microgram per milliliter | Standard Deviation 0.525 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 14 | 7.07 Microgram per milliliter | Standard Deviation 2.544 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 0 | 0.01 Microgram per milliliter | Standard Deviation 0.03 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 10 | 13.49 Microgram per milliliter | Standard Deviation 3.67 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 2 | 3.73 Microgram per milliliter | Standard Deviation 2.581 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 38 | 0.02 Microgram per milliliter | Standard Deviation 0.051 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 5 | 7.40 Microgram per milliliter | Standard Deviation 3.402 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 10 Day 4 | 19.07 Microgram per milliliter | Standard Deviation 4.63 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 8 | 6.01 Microgram per milliliter | Standard Deviation 2.861 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 18 | 2.74 Microgram per milliliter | Standard Deviation 1.737 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Day 11 | 5.42 Microgram per milliliter | Standard Deviation 1.866 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 10 Day 7 | 18.71 Microgram per milliliter | Standard Deviation 4.111 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 2 | 4.78 Microgram per milliliter | Standard Deviation 1.549 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 24 | 0.88 Microgram per milliliter | Standard Deviation 0.599 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 4 | 8.83 Microgram per milliliter | Standard Deviation 3.251 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 12 | 14.31 Microgram per milliliter | Standard Deviation 3.438 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 6 | 10.49 Microgram per milliliter | Standard Deviation 3.327 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 22 | 1.18 Microgram per milliliter | Standard Deviation 0.816 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part A) | Week 8 | 12.36 Microgram per milliliter | Standard Deviation 3.133 |
Secondary
Serum Sirukumab Concentrations Through Week 38 (Part B)
Sirukumab Concentrations in serum were measured.
Time frame: Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38
Population: Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 7 | 15.14 Microgram per milliliter | Standard Deviation 5.991 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 30 | 4.49 Microgram per milliliter | Standard Deviation 2.708 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 5 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 12 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 2 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 28 | 6.93 Microgram per milliliter | Standard Deviation 3.378 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 34 | 1.88 Microgram per milliliter | Standard Deviation 1.451 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 8 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 20 | 9.94 Microgram per milliliter | Standard Deviation 3.646 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 4 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 8 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 | 11.04 Microgram per milliliter | Standard Deviation 4.607 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 26 | 10.97 Microgram per milliliter | Standard Deviation 4.565 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 4 | 16.46 Microgram per milliliter | Standard Deviation 6.826 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 16 | 6.84 Microgram per milliliter | Standard Deviation 2.27 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 0 | NA Microgram per milliliter | — |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 38 | 0.71 Microgram per milliliter | Standard Deviation 0.756 |
| Part B: Placebo | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 11 | 0.02 Microgram per milliliter | Standard Deviation 0.063 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 20 | 10.29 Microgram per milliliter | Standard Deviation 4.951 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 4 | 17.34 Microgram per milliliter | Standard Deviation 9.046 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 38 | 0.72 Microgram per milliliter | Standard Deviation 0.704 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 7 | 15.01 Microgram per milliliter | Standard Deviation 7.853 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 26 | 10.09 Microgram per milliliter | Standard Deviation 6.808 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 8 | 5.67 Microgram per milliliter | Standard Deviation 2.398 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 0 | 0.03 Microgram per milliliter | Standard Deviation 0.087 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 11 | 4.50 Microgram per milliliter | Standard Deviation 2.307 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 2 | 4.30 Microgram per milliliter | Standard Deviation 2.265 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 34 | 1.92 Microgram per milliliter | Standard Deviation 1.403 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 4 | 7.16 Microgram per milliliter | Standard Deviation 3.29 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 8 | 10.54 Microgram per milliliter | Standard Deviation 5.008 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 30 | 4.06 Microgram per milliliter | Standard Deviation 2.341 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 12 | 11.63 Microgram per milliliter | Standard Deviation 5.232 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 16 | 9.96 Microgram per milliliter | Standard Deviation 5.107 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 5 | 6.75 Microgram per milliliter | Standard Deviation 3.212 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 28 | 6.69 Microgram per milliliter | Standard Deviation 4.329 |
| Part B: Sirukumab 100 mg q2 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 | 10.73 Microgram per milliliter | Standard Deviation 5.182 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 34 | 0.94 Microgram per milliliter | Standard Deviation 0.948 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 5 | 6.21 Microgram per milliliter | Standard Deviation 2.933 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 12 | 3.10 Microgram per milliliter | Standard Deviation 1.633 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 0 | 0.00 Microgram per milliliter | Standard Deviation 0 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 11 | 4.68 Microgram per milliliter | Standard Deviation 2.539 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 8 | 5.85 Microgram per milliliter | Standard Deviation 2.774 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 | 3.80 Microgram per milliliter | Standard Deviation 2.815 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 16 | 3.51 Microgram per milliliter | Standard Deviation 2.545 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 4 | 9.06 Microgram per milliliter | Standard Deviation 5.632 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 28 | 4.15 Microgram per milliliter | Standard Deviation 2.83 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 7 | 9.58 Microgram per milliliter | Standard Deviation 5.721 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 4 | 2.02 Microgram per milliliter | Standard Deviation 1.073 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 38 | 0.29 Microgram per milliliter | Standard Deviation 0.382 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 2 | 3.81 Microgram per milliliter | Standard Deviation 1.934 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 26 | 6.49 Microgram per milliliter | Standard Deviation 5.401 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 8 | 3.08 Microgram per milliliter | Standard Deviation 1.806 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 30 | 2.42 Microgram per milliliter | Standard Deviation 1.931 |
| Part B: Sirukumab 100 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 20 | 3.92 Microgram per milliliter | Standard Deviation 2.665 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 8 | 1.45 Microgram per milliliter | Standard Deviation 0.764 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 0 | 0.02 Microgram per milliliter | Standard Deviation 0.076 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 5 | 2.66 Microgram per milliliter | Standard Deviation 1.447 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 8 | 2.61 Microgram per milliliter | Standard Deviation 1.339 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 11 | 2.54 Microgram per milliliter | Standard Deviation 1.233 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 2 | 1.97 Microgram per milliliter | Standard Deviation 0.916 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 4 | 0.97 Microgram per milliliter | Standard Deviation 0.47 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 12 | 1.79 Microgram per milliliter | Standard Deviation 0.836 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 16 | 2.03 Microgram per milliliter | Standard Deviation 1.366 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 20 | 1.80 Microgram per milliliter | Standard Deviation 1.03 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 | 1.89 Microgram per milliliter | Standard Deviation 1.042 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 4 | 4.42 Microgram per milliliter | Standard Deviation 1.293 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 7 | 4.52 Microgram per milliliter | Standard Deviation 1.719 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 26 | 3.72 Microgram per milliliter | Standard Deviation 1.434 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 28 | 1.84 Microgram per milliliter | Standard Deviation 0.764 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 30 | 1.07 Microgram per milliliter | Standard Deviation 0.529 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 34 | 0.39 Microgram per milliliter | Standard Deviation 0.396 |
| Part B: Sirukumab 50 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 38 | 0.08 Microgram per milliliter | Standard Deviation 0.114 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 20 | 1.03 Microgram per milliliter | Standard Deviation 0.496 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 16 | 0.98 Microgram per milliliter | Standard Deviation 0.425 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 8 | 1.49 Microgram per milliliter | Standard Deviation 0.556 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 28 | 1.06 Microgram per milliliter | Standard Deviation 0.539 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 12 | 0.99 Microgram per milliliter | Standard Deviation 0.478 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 8 | 0.99 Microgram per milliliter | Standard Deviation 0.56 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 38 | 0.01 Microgram per milliliter | Standard Deviation 0.037 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 5 | 1.59 Microgram per milliliter | Standard Deviation 0.808 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 30 | 0.52 Microgram per milliliter | Standard Deviation 0.335 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 4 | 0.85 Microgram per milliliter | Standard Deviation 1.167 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 2 | 1.16 Microgram per milliliter | Standard Deviation 0.426 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Day 11 | 1.26 Microgram per milliliter | Standard Deviation 0.516 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 0 | 0.01 Microgram per milliliter | Standard Deviation 0.048 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 7 | 2.80 Microgram per milliliter | Standard Deviation 1.58 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 Day 4 | 3.36 Microgram per milliliter | Standard Deviation 1.578 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 34 | 0.10 Microgram per milliliter | Standard Deviation 0.138 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 26 | 1.91 Microgram per milliliter | Standard Deviation 1.009 |
| Part B: Sirukumab 25 mg q4 Weeks | Serum Sirukumab Concentrations Through Week 38 (Part B) | Week 24 | 1.04 Microgram per milliliter | Standard Deviation 0.491 |