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

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ClinicalTrials.gov Identifier: NCT01689532
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: Sirukumab 100 mg
Drug: Sirukumab 50 mg
Drug: Placebo
Enrollment 122
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description 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. Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Period Title: Overall Study
Started 61 61
Completed 47 52
Not Completed 14 9
Reason Not Completed
Adverse Event             9             5
Lack of Efficacy             2             2
Withdrawal by Subject             1             2
Physician Decision             2             0
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg Total
Hide Arm/Group Description 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. Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52. Total of all reporting groups
Overall Number of Baseline Participants 61 61 122
Hide Baseline Analysis Population Description
Baseline population included all randomized participants who received study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 61 participants 122 participants
55.4  (10.7) 54.7  (12.16) 55.1  (11.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Female
47
  77.0%
43
  70.5%
90
  73.8%
Male
14
  23.0%
18
  29.5%
32
  26.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
JAPAN Number Analyzed 61 participants 61 participants 122 participants
61 61 122
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAE)
Hide Description 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.
Time Frame Baseline upto Week 68
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: participants
56 58
2.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
Hide Description 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).
Time Frame At Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 77.0 72.1
Week 24 73.8 82.0
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
Hide Description 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.
Time Frame At Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 47.5 57.4
Week 24 49.2 63.9
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
Hide Description 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.
Time Frame At Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 26.2 32.8
Week 24 24.6 36.1
5.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response
Hide Description 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.
Time Frame At Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 8.2 11.5
Week 24 6.6 14.8
6.Secondary Outcome
Title Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 -65.66  (40.201) -73.84  (31.162)
Change at Week 24 -71.16  (38.343) -75.82  (30.860)
7.Secondary Outcome
Title Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 -63.95  (41.738) -65.58  (41.898)
Change at Week 24 -65.58  (41.933) -67.34  (42.145)
8.Secondary Outcome
Title Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24
Hide Description 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).
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 -53.44  (39.043) -52.94  (44.384)
Change at Week 24 -52.45  (38.266) -57.56  (49.725)
9.Secondary Outcome
Title Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24
Hide Description Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 -50.64  (48.679) -53.15  (38.925)
Change at Week 24 -51.55  (50.569) -56.94  (42.208)
10.Secondary Outcome
Title Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24
Hide Description 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).
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 -65.28  (27.268) -66.17  (28.774)
Change at Week 24 -67.54  (25.521) -68.44  (27.161)
11.Secondary Outcome
Title Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 (n= 59, 58) -38.90  (53.204) -46.18  (48.572)
Change at Week 24 (n= 59, 58) -42.25  (52.741) -48.98  (44.917)
12.Secondary Outcome
Title Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24
Hide Description Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 16 -98.60  (2.026) -98.97  (1.637)
Change at Week 24 -98.64  (2.148) -98.99  (1.251)
13.Secondary Outcome
Title Percentage of Participants Who Achieved Major Clinical Response at Week 52
Hide Description 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).
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
13.1 24.6
14.Secondary Outcome
Title Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24
Hide Description 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.
Time Frame At Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 90.2 96.7
Week 24 88.5 96.7
15.Secondary Outcome
Title Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24
Hide Description 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.
Time Frame At Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
49.2 59.0
16.Secondary Outcome
Title Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.566  (0.8088) 5.805  (1.0553)
Change at Week 16 -2.858  (1.1867) -3.069  (1.1483)
Change at Week 24 -2.949  (1.2445) -3.185  (1.1552)
17.Secondary Outcome
Title Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52
Hide Description 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.
Time Frame At Weeks 16, 24 and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 14.8 19.7
Week 24 16.4 18.0
Week 52 18.0 26.2
18.Secondary Outcome
Title Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52
Hide Description 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.
Time Frame At Weeks 16, 24 and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 4.9 14.8
Week 24 9.8 8.2
Week 52 8.2 13.1
19.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 31.36  (9.454) 35.69  (13.923)
Change at Week 16 -19.43  (12.138) -22.69  (13.231)
Change at Week 24 -20.27  (12.207) -23.86  (13.487)
20.Secondary Outcome
Title Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
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All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
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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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 34.318  (9.6078) 38.911  (14.7996)
Change at Week 16 -22.365  (12.4411) -25.896  (13.9910)
Change at Week 24 -23.206  (12.6842) -27.064  (14.2368)
21.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24
Hide Description 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.
Time Frame Baseline, at Week 16 and 24
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All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
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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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.3484  (0.65396) 1.1721  (0.64111)
Change at Week 16 -0.5676  (0.53695) -0.4980  (0.61343)
Change at Week 24 -0.5738  (0.54600) -0.5697  (0.56758)
22.Secondary Outcome
Title Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24
Hide Description 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.
Time Frame At Weeks 16 and 24
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
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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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 75.4 67.2
Week 24 73.8 70.5
23.Secondary Outcome
Title Percentage of Participants Maintaining HAQ-DI Response
Hide Description 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.
Time Frame Baseline upto Week 52
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants
70.5 65.6
24.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline, Weeks 24 and 52
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
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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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale*week
Week 0 Through Week 24 -74.0645  (78.34712) -69.2439  (75.85153)
Week 0 Through Week 52 -189.2531  (178.07291) -187.4068  (191.77329)
25.Secondary Outcome
Title Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24
Hide Description 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.
Time Frame Baseline, Weeks 16 and 24
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
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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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: minute
Change at Week 16 -103.8  (268.32) -160.4  (374.17)
Change at Week 24 -77.6  (334.00) -169.4  (374.36)
26.Secondary Outcome
Title Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52
Hide Description 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.
Time Frame Baseline, Weeks 16, 24 and 52
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Mental Component Score [MCS]) 45.49  (9.577) 46.55  (11.332)
Change at Week 16 (MCS) 5.38  (9.655) 6.46  (9.183)
Change at Week 24 (MCS) 5.82  (10.376) 6.81  (9.273)
Change at Week 52 (MCS) 6.74  (9.681) 6.27  (9.915)
27.Secondary Outcome
Title Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52
Hide Description 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.
Time Frame Baseline, Weeks 16, 24 and 52
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Physical Component Score [PCS]) 22.12  (15.315) 24.10  (15.642)
Change at Week 16 (PCS) 12.12  (14.349) 12.48  (15.886)
Change at Week 24 (PCS) 12.45  (15.979) 14.72  (15.290)
Change at Week 52 (PCS) 13.67  (15.754) 14.30  (15.395)
28.Secondary Outcome
Title Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52
Hide Description 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.
Time Frame Baseline, Weeks 16, 24 and 52
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 16 30.20  (26.145) 25.93  (27.371)
Change at Week 24 32.46  (26.562) 28.85  (28.397)
Change at Week 52 33.54  (26.972) 31.50  (29.666)
29.Secondary Outcome
Title Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52
Hide Description 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.
Time Frame Baseline, Weeks 16, 24 and 52
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Hide Analysis Population Description
All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description:
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.
Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 16 0.16  (0.173) 0.18  (0.177)
Change at Week 24 0.17  (0.169) 0.19  (0.172)
Change at Week 52 0.16  (0.164) 0.19  (0.166)
Time Frame Baseline up to Week 68
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Hide Arm/Group Description 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. Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
All-Cause Mortality
Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/61 (6.56%)   5/61 (8.20%) 
Gastrointestinal disorders     
Gastrooesophageal Reflux Disease * 1  0/61 (0.00%)  1/61 (1.64%) 
Large Intestine Polyp * 1  1/61 (1.64%)  0/61 (0.00%) 
Infections and infestations     
Acute Sinusitis * 1  0/61 (0.00%)  1/61 (1.64%) 
Hepatitis E * 1  0/61 (0.00%)  1/61 (1.64%) 
Osteomyelitis * 1  1/61 (1.64%)  0/61 (0.00%) 
Injury, poisoning and procedural complications     
Comminuted Fracture * 1  1/61 (1.64%)  0/61 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion * 1  0/61 (0.00%)  1/61 (1.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Borderline Serous Tumour of Ovary * 1  0/61 (0.00%)  1/61 (1.64%) 
Psychiatric disorders     
Schizophrenia * 1  1/61 (1.64%)  0/61 (0.00%) 
Reproductive system and breast disorders     
Endometriosis * 1  0/61 (0.00%)  1/61 (1.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sirukumab 50 Milligram (mg) Sirukumab 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   48/61 (78.69%)   51/61 (83.61%) 
Gastrointestinal disorders     
Diarrhoea * 1  5/61 (8.20%)  3/61 (4.92%) 
General disorders     
Injection Site Erythema * 1  19/61 (31.15%)  20/61 (32.79%) 
Injection Site Pruritus * 1  7/61 (11.48%)  13/61 (21.31%) 
Injection Site Swelling * 1  10/61 (16.39%)  12/61 (19.67%) 
Infections and infestations     
Bronchitis * 1  5/61 (8.20%)  0/61 (0.00%) 
Gastroenteritis * 1  4/61 (6.56%)  1/61 (1.64%) 
Nasopharyngitis * 1  27/61 (44.26%)  27/61 (44.26%) 
Paronychia * 1  6/61 (9.84%)  2/61 (3.28%) 
Pharyngitis * 1  6/61 (9.84%)  7/61 (11.48%) 
Tinea Pedis * 1  4/61 (6.56%)  1/61 (1.64%) 
Injury, poisoning and procedural complications     
Skin Abrasion * 1  4/61 (6.56%)  1/61 (1.64%) 
Investigations     
Alanine Aminotransferase Increased * 1  10/61 (16.39%)  10/61 (16.39%) 
Aspartate Aminotransferase Increased * 1  9/61 (14.75%)  11/61 (18.03%) 
Neutrophil Count Decreased * 1  7/61 (11.48%)  4/61 (6.56%) 
Platelet Count Decreased * 1  9/61 (14.75%)  3/61 (4.92%) 
White Blood Cell Count Decreased * 1  7/61 (11.48%)  7/61 (11.48%) 
Skin and subcutaneous tissue disorders     
Dermatitis Allergic * 1  0/61 (0.00%)  4/61 (6.56%) 
Eczema * 1  7/61 (11.48%)  7/61 (11.48%) 
Rash * 1  1/61 (1.64%)  4/61 (6.56%) 
Urticaria * 1  4/61 (6.56%)  3/61 (4.92%) 
Vascular disorders     
Hypertension * 1  5/61 (8.20%)  7/61 (11.48%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Manager
Organization: Janssen Pharmaceutical K.K.
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01689532     History of Changes
Other Study ID Numbers: CR100876
CNTO136ARA3001 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: September 18, 2012
First Posted: September 21, 2012
Results First Submitted: July 8, 2016
Results First Posted: October 27, 2016
Last Update Posted: October 27, 2016