Trial Outcomes & Findings for A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine (NCT NCT01689532)

NCT ID: NCT01689532

Last Updated: 2016-10-27

Results Overview

A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is \[i.e.\] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 122 participants
• Primary outcome timeframe: Baseline upto Week 68
• Results posted on: 2016-10-27

Participant Flow

Of the 180 participants who signed informed consent of this study, 122 participants (61 participants in each treatment group) were randomized and treated during the study.

Participant milestones

Measure	Sirukumab 50 Milligram (mg) Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Study STARTED	61	61
Overall Study COMPLETED	47	52
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Measure	Sirukumab 50 Milligram (mg) Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Study Adverse Event	9	5
Overall Study Lack of Efficacy	2	2
Overall Study Withdrawal by Subject	1	2
Overall Study Physician Decision	2	0

Baseline Characteristics

A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

Baseline characteristics by cohort

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.	Total n=122 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	54.7 years STANDARD_DEVIATION 12.16 • n=7 Participants	55.1 years STANDARD_DEVIATION 11.41 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment JAPAN	61 participants n=5 Participants	61 participants n=7 Participants	122 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline upto Week 68

Population: Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.

A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Number of Participants With Treatment Emergent Adverse Events (TEAE)	56 participants	58 participants

SECONDARY outcome

Timeframe: At Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response Week 16	77.0 percentage of participants	72.1 percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response Week 24	73.8 percentage of participants	82.0 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response Week 16	47.5 percentage of participants	57.4 percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response Week 24	49.2 percentage of participants	63.9 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response Week 16	26.2 percentage of participants	32.8 percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response Week 24	24.6 percentage of participants	36.1 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The ACR 90 Response is defined as >=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response Week 16	8.2 percentage of participants	11.5 percentage of participants
Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response Week 24	6.6 percentage of participants	14.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24 Change at Week 16	-65.66 percent change Standard Deviation 40.201	-73.84 percent change Standard Deviation 31.162
Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24 Change at Week 24	-71.16 percent change Standard Deviation 38.343	-75.82 percent change Standard Deviation 30.860

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24 Change at Week 16	-63.95 percent change Standard Deviation 41.738	-65.58 percent change Standard Deviation 41.898
Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24 Change at Week 24	-65.58 percent change Standard Deviation 41.933	-67.34 percent change Standard Deviation 42.145

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24 Change at Week 16	-53.44 percent change Standard Deviation 39.043	-52.94 percent change Standard Deviation 44.384
Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24 Change at Week 24	-52.45 percent change Standard Deviation 38.266	-57.56 percent change Standard Deviation 49.725

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24 Change at Week 16	-50.64 percent change Standard Deviation 48.679	-53.15 percent change Standard Deviation 38.925
Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24 Change at Week 24	-51.55 percent change Standard Deviation 50.569	-56.94 percent change Standard Deviation 42.208

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24 Change at Week 24	-67.54 percent change Standard Deviation 25.521	-68.44 percent change Standard Deviation 27.161
Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24 Change at Week 16	-65.28 percent change Standard Deviation 27.268	-66.17 percent change Standard Deviation 28.774

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The HAQ-DI is a 20-question instrument that 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 to 3 (0=no difficulty and 3=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. Here, 'n' signifies those participants who were evaluable for the specific timepoint.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24 Change at Week 16 (n= 59, 58)	-38.90 percent change Standard Deviation 53.204	-46.18 percent change Standard Deviation 48.572
Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24 Change at Week 24 (n= 59, 58)	-42.25 percent change Standard Deviation 52.741	-48.98 percent change Standard Deviation 44.917

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24 Change at Week 16	-98.60 percent change Standard Deviation 2.026	-98.97 percent change Standard Deviation 1.637
Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24 Change at Week 24	-98.64 percent change Standard Deviation 2.148	-98.99 percent change Standard Deviation 1.251

SECONDARY outcome

Timeframe: Week 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Who Achieved Major Clinical Response at Week 52	13.1 percentage of participants	24.6 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

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. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24 Week 24	88.5 percentage of participants	96.7 percentage of participants
Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24 Week 16	90.2 percentage of participants	96.7 percentage of participants

SECONDARY outcome

Timeframe: At Week 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

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. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24	49.2 percentage of participants	59.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

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.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24 Change at Week 16	-2.858 units on a scale Standard Deviation 1.1867	-3.069 units on a scale Standard Deviation 1.1483
Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24 Change at Week 24	-2.949 units on a scale Standard Deviation 1.2445	-3.185 units on a scale Standard Deviation 1.1552
Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24 Baseline	5.566 units on a scale Standard Deviation 0.8088	5.805 units on a scale Standard Deviation 1.0553

SECONDARY outcome

Timeframe: At Weeks 16, 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician's global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at the visit.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52 Week 16	14.8 percentage of participants	19.7 percentage of participants
Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52 Week 24	16.4 percentage of participants	18.0 percentage of participants
Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52 Week 52	18.0 percentage of participants	26.2 percentage of participants

SECONDARY outcome

Timeframe: At Weeks 16, 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The 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 to 10 scale.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52 Week 16	4.9 percentage of participants	14.8 percentage of participants
Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52 Week 24	9.8 percentage of participants	8.2 percentage of participants
Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52 Week 52	8.2 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The CDAI score is a derived score combining 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 range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24 Baseline	31.36 units on a scale Standard Deviation 9.454	35.69 units on a scale Standard Deviation 13.923
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24 Change at Week 16	-19.43 units on a scale Standard Deviation 12.138	-22.69 units on a scale Standard Deviation 13.231
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24 Change at Week 24	-20.27 units on a scale Standard Deviation 12.207	-23.86 units on a scale Standard Deviation 13.487

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI <=3.3; Low Disease Activity SDAI >3.3 and <=11; Moderate Disease Activity SDAI >11 and <=26; High Disease Activity SDAI >26.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24 Baseline	34.318 units on a scale Standard Deviation 9.6078	38.911 units on a scale Standard Deviation 14.7996
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24 Change at Week 16	-22.365 units on a scale Standard Deviation 12.4411	-25.896 units on a scale Standard Deviation 13.9910
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24 Change at Week 24	-23.206 units on a scale Standard Deviation 12.6842	-27.064 units on a scale Standard Deviation 14.2368

SECONDARY outcome

Timeframe: Baseline, at Week 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (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.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24 Baseline	1.3484 units on a scale Standard Deviation 0.65396	1.1721 units on a scale Standard Deviation 0.64111
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24 Change at Week 16	-0.5676 units on a scale Standard Deviation 0.53695	-0.4980 units on a scale Standard Deviation 0.61343
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24 Change at Week 24	-0.5738 units on a scale Standard Deviation 0.54600	-0.5697 units on a scale Standard Deviation 0.56758

SECONDARY outcome

Timeframe: At Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of > -0.22 from baseline in HAQ-DI score.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24 Week 16	75.4 percentage of participants	67.2 percentage of participants
Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24 Week 24	73.8 percentage of participants	70.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline upto Week 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of > -0.22 in HAQ-DI score.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Percentage of Participants Maintaining HAQ-DI Response	70.5 percentage of participants	65.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (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. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52 Week 0 Through Week 24	-74.0645 units on a scale*week Standard Deviation 78.34712	-69.2439 units on a scale*week Standard Deviation 75.85153
Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52 Week 0 Through Week 52	-189.2531 units on a scale*week Standard Deviation 178.07291	-187.4068 units on a scale*week Standard Deviation 191.77329

SECONDARY outcome

Timeframe: Baseline, Weeks 16 and 24

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24 Change at Week 16	-103.8 minute Standard Deviation 268.32	-160.4 minute Standard Deviation 374.17
Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24 Change at Week 24	-77.6 minute Standard Deviation 334.00	-169.4 minute Standard Deviation 374.36

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Change at Week 16 (MCS)	5.38 units on a scale Standard Deviation 9.655	6.46 units on a scale Standard Deviation 9.183
Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Change at Week 52 (MCS)	6.74 units on a scale Standard Deviation 9.681	6.27 units on a scale Standard Deviation 9.915
Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Baseline (Mental Component Score [MCS])	45.49 units on a scale Standard Deviation 9.577	46.55 units on a scale Standard Deviation 11.332
Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Change at Week 24 (MCS)	5.82 units on a scale Standard Deviation 10.376	6.81 units on a scale Standard Deviation 9.273

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Baseline (Physical Component Score [PCS])	22.12 units on a scale Standard Deviation 15.315	24.10 units on a scale Standard Deviation 15.642
Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Change at Week 16 (PCS)	12.12 units on a scale Standard Deviation 14.349	12.48 units on a scale Standard Deviation 15.886
Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Change at Week 24 (PCS)	12.45 units on a scale Standard Deviation 15.979	14.72 units on a scale Standard Deviation 15.290
Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52 Change at Week 52 (PCS)	13.67 units on a scale Standard Deviation 15.754	14.30 units on a scale Standard Deviation 15.395

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52 Change at Week 16	30.20 units on a scale Standard Deviation 26.145	25.93 units on a scale Standard Deviation 27.371
Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52 Change at Week 24	32.46 units on a scale Standard Deviation 26.562	28.85 units on a scale Standard Deviation 28.397
Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52 Change at Week 52	33.54 units on a scale Standard Deviation 26.972	31.50 units on a scale Standard Deviation 29.666

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24 and 52

Population: All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.

Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead.

Outcome measures

Measure	Sirukumab 50 Milligram (mg) n=61 Participants Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 Participants Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52 Change at Week 16	0.16 units on a scale Standard Deviation 0.173	0.18 units on a scale Standard Deviation 0.177
Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52 Change at Week 24	0.17 units on a scale Standard Deviation 0.169	0.19 units on a scale Standard Deviation 0.172
Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52 Change at Week 52	0.16 units on a scale Standard Deviation 0.164	0.19 units on a scale Standard Deviation 0.166

Adverse Events

Sirukumab 50 Milligram (mg)

Serious events: 4 serious events

Other events: 48 other events

Deaths: 0 deaths

Sirukumab 100 mg

Serious events: 5 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sirukumab 50 Milligram (mg) n=61 participants at risk Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 participants at risk Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Gastrointestinal disorders Large Intestine Polyp	1.6% 1/61 • Baseline up to Week 68	0.00% 0/61 • Baseline up to Week 68
Infections and infestations Acute Sinusitis	0.00% 0/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Infections and infestations Hepatitis E	0.00% 0/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Infections and infestations Osteomyelitis	1.6% 1/61 • Baseline up to Week 68	0.00% 0/61 • Baseline up to Week 68
Injury, poisoning and procedural complications Comminuted Fracture	1.6% 1/61 • Baseline up to Week 68	0.00% 0/61 • Baseline up to Week 68
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline Serous Tumour of Ovary	0.00% 0/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Psychiatric disorders Schizophrenia	1.6% 1/61 • Baseline up to Week 68	0.00% 0/61 • Baseline up to Week 68
Reproductive system and breast disorders Endometriosis	0.00% 0/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68

Other adverse events

Measure	Sirukumab 50 Milligram (mg) n=61 participants at risk Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.	Sirukumab 100 mg n=61 participants at risk Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Gastrointestinal disorders Diarrhoea	8.2% 5/61 • Baseline up to Week 68	4.9% 3/61 • Baseline up to Week 68
General disorders Injection Site Erythema	31.1% 19/61 • Baseline up to Week 68	32.8% 20/61 • Baseline up to Week 68
General disorders Injection Site Pruritus	11.5% 7/61 • Baseline up to Week 68	21.3% 13/61 • Baseline up to Week 68
General disorders Injection Site Swelling	16.4% 10/61 • Baseline up to Week 68	19.7% 12/61 • Baseline up to Week 68
Infections and infestations Bronchitis	8.2% 5/61 • Baseline up to Week 68	0.00% 0/61 • Baseline up to Week 68
Infections and infestations Gastroenteritis	6.6% 4/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Infections and infestations Nasopharyngitis	44.3% 27/61 • Baseline up to Week 68	44.3% 27/61 • Baseline up to Week 68
Infections and infestations Paronychia	9.8% 6/61 • Baseline up to Week 68	3.3% 2/61 • Baseline up to Week 68
Infections and infestations Pharyngitis	9.8% 6/61 • Baseline up to Week 68	11.5% 7/61 • Baseline up to Week 68
Infections and infestations Tinea Pedis	6.6% 4/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Injury, poisoning and procedural complications Skin Abrasion	6.6% 4/61 • Baseline up to Week 68	1.6% 1/61 • Baseline up to Week 68
Investigations Alanine Aminotransferase Increased	16.4% 10/61 • Baseline up to Week 68	16.4% 10/61 • Baseline up to Week 68
Investigations Aspartate Aminotransferase Increased	14.8% 9/61 • Baseline up to Week 68	18.0% 11/61 • Baseline up to Week 68
Investigations Neutrophil Count Decreased	11.5% 7/61 • Baseline up to Week 68	6.6% 4/61 • Baseline up to Week 68
Investigations Platelet Count Decreased	14.8% 9/61 • Baseline up to Week 68	4.9% 3/61 • Baseline up to Week 68
Investigations White Blood Cell Count Decreased	11.5% 7/61 • Baseline up to Week 68	11.5% 7/61 • Baseline up to Week 68
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/61 • Baseline up to Week 68	6.6% 4/61 • Baseline up to Week 68
Skin and subcutaneous tissue disorders Eczema	11.5% 7/61 • Baseline up to Week 68	11.5% 7/61 • Baseline up to Week 68
Skin and subcutaneous tissue disorders Rash	1.6% 1/61 • Baseline up to Week 68	6.6% 4/61 • Baseline up to Week 68
Skin and subcutaneous tissue disorders Urticaria	6.6% 4/61 • Baseline up to Week 68	4.9% 3/61 • Baseline up to Week 68
Vascular disorders Hypertension	8.2% 5/61 • Baseline up to Week 68	11.5% 7/61 • Baseline up to Week 68

Additional Information

Senior Manager

Janssen Pharmaceutical K.K.

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER