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A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00718718
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : December 4, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: CNTO 136 100 mg
Drug: CNTO 136 50 mg
Drug: CNTO 136 25 mg
Drug: Placebo
Drug: Methotrexate
Enrollment 187
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A - Placebo (Wk 0-Wk 12) Part A - Placebo Then Sirukumab (Wk 12 to End of Study) Part A - Sirukumab (Wk 0-Wk 12) Part A - Sirukumab Then Placebo (Wk 12 to End of Study) Part B - Placebo (Wk 0-Wk 12) Part B - Placebo Then Sirukumab 100 mg q2 Weeks Part B - Sirukumab 100mg q2w Part B - Sirukumab 100mg q4w Part B - Sirukumab 50mg q4w Part B: Sirukumab 25 mg q4 Weeks
Hide Arm/Group Description Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Participants received placebo at Weeks 12 and q2w through Week 22. Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks. Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Period Title: Prior to Week 12
Started 19 0 17 0 30 0 30 30 30 31
Completed 18 0 16 0 27 0 29 28 28 31
Not Completed 1 0 1 0 3 0 1 2 2 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1             1             0
Withdrawal by Subject             0             0             0             0             3             0             1             1             1             0
Other             1             0             1             0             0             0             0             0             0             0
Period Title: Week 12 to End of Study
Started 0 18 0 16 0 27 29 28 28 31
Treated 0 18 0 16 0 26 29 28 28 31
Completed 0 17 0 15 0 24 27 27 27 31
Not Completed 0 1 0 1 0 3 2 1 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1             0             0
Death             0             0             0             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             2             1             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             1             0
Other             0             1             0             1             0             0             1             0             0             0
Arm/Group Title Part A: Placebo Part A: Sirukumab 100 mg q2 Weeks Part B: Placebo Part B: Sirukumab 100 mg q2 Weeks Part B: Sirukumab 100 mg q4 Weeks Part B: Sirukumab 50 mg q4 Weeks Part B: Sirukumab 25 mg q4 Weeks Total
Hide Arm/Group Description Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22. Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. Total of all reporting groups
Overall Number of Baseline Participants 19 17 30 30 30 30 31 187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 30 participants 30 participants 30 participants 30 participants 31 participants 187 participants
46.2  (10.24) 50.1  (10.72) 54.1  (12.72) 53.8  (13.02) 52  (11) 50.9  (10.29) 52.8  (9.41) 51.8  (11.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 30 participants 30 participants 30 participants 30 participants 31 participants 187 participants
Female
11
  57.9%
14
  82.4%
25
  83.3%
27
  90.0%
27
  90.0%
26
  86.7%
23
  74.2%
153
  81.8%
Male
8
  42.1%
3
  17.6%
5
  16.7%
3
  10.0%
3
  10.0%
4
  13.3%
8
  25.8%
34
  18.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 30 participants 30 participants 30 participants 30 participants 31 participants 187 participants
Hungary
0
   0.0%
0
   0.0%
2
   6.7%
5
  16.7%
3
  10.0%
3
  10.0%
4
  12.9%
17
   9.1%
Japan
0
   0.0%
0
   0.0%
5
  16.7%
5
  16.7%
5
  16.7%
6
  20.0%
6
  19.4%
27
  14.4%
Mexico
0
   0.0%
0
   0.0%
5
  16.7%
3
  10.0%
4
  13.3%
5
  16.7%
6
  19.4%
23
  12.3%
Poland
13
  68.4%
12
  70.6%
9
  30.0%
10
  33.3%
6
  20.0%
5
  16.7%
7
  22.6%
62
  33.2%
Republic of Korea
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.3%
1
   3.3%
2
   6.7%
1
   3.2%
5
   2.7%
Russian Federation
0
   0.0%
0
   0.0%
9
  30.0%
6
  20.0%
10
  33.3%
9
  30.0%
7
  22.6%
41
  21.9%
United States
6
  31.6%
5
  29.4%
0
   0.0%
0
   0.0%
1
   3.3%
0
   0.0%
0
   0.0%
12
   6.4%
1.Primary Outcome
Title Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)
Hide Description An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants in Part B.
Arm/Group Title Part B: Placebo Part B: Sirukumab 100 mg q2 Weeks Part B: Sirukumab 100 mg q4 Weeks Part B: Sirukumab 50 mg q4 Weeks Part B: Sirukumab 25 mg q4 Weeks
Hide Arm/Group Description:
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Overall Number of Participants Analyzed 30 30 30 30 31
Measure Type: Number
Unit of Measure: Percentage of Participants
3.3 26.7 23.3 26.7 19.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 100 mg q2 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 100 mg q4 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 50 mg q4 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 25 mg q4 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)
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. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
Arm/Group Title Part A: Placebo Part A: Sirukumab 100 mg q2 Weeks Part B: Placebo Part B: Sirukumab 100 mg q2 Weeks Part B: Sirukumab 100 mg q4 Weeks Part B: Sirukumab 50 mg q4 Weeks Part B: Sirukumab 25 mg q4 Weeks
Hide Arm/Group Description:
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Overall Number of Participants Analyzed 19 17 30 30 30 30 31
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Baseline Number Analyzed 19 participants 17 participants 29 participants 30 participants 30 participants 29 participants 31 participants
6.341  (0.9034) 5.919  (0.9676) 5.908  (0.7332) 5.755  (0.9706) 6.190  (0.6829) 6.051  (0.8791) 5.688  (0.9529)
Change at Week 12 Number Analyzed 17 participants 14 participants 29 participants 30 participants 30 participants 29 participants 31 participants
-0.619  (0.8541) -2.075  (0.7979) -1.073  (0.9766) -2.248  (1.2050) -2.011  (0.8843) -2.198  (0.8550) -1.964  (0.9532)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Part A: Sirukumab 100 mg q2 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Van Der Waerden ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 100 mg q2 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Van Der Waerden ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 100 mg q4 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Van Der Waerden ANOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 50 mg q4 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Van Der Waerden ANOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Sirukumab 25 mg q4 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Van Der Waerden ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)
Hide Description An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Part A: Placebo Part A: Sirukumab 100 mg q2 Weeks
Hide Arm/Group Description:
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: Percentage of Participants
5.9 28.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part A: Placebo, Part A: Sirukumab 100 mg q2 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Serum Sirukumab Concentrations Through Week 38 (Part A)
Hide Description Sirukumab Concentrations in serum were measured.
Time Frame Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.
Arm/Group Title Part A: Placebo Part A: Sirukumab 100 mg q2 Weeks
Hide Arm/Group Description:
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: Microgram per milliliter
Week 0 Number Analyzed 17 participants 14 participants
NA [1]   (NA) 0.01  (0.030)
Day 2 Number Analyzed 16 participants 12 participants
NA [2]   (NA) 3.73  (2.581)
Day 5 Number Analyzed 14 participants 10 participants
NA [2]   (NA) 7.40  (3.402)
Day 8 Number Analyzed 17 participants 12 participants
NA [2]   (NA) 6.01  (2.861)
Day 11 Number Analyzed 16 participants 14 participants
NA [2]   (NA) 5.42  (1.866)
Week 2 Number Analyzed 14 participants 13 participants
NA [2]   (NA) 4.78  (1.549)
Week 4 Number Analyzed 17 participants 13 participants
NA [2]   (NA) 8.83  (3.251)
Week 6 Number Analyzed 15 participants 12 participants
NA [2]   (NA) 10.49  (3.327)
Week 8 Number Analyzed 16 participants 11 participants
NA [2]   (NA) 12.36  (3.133)
Week 10 Number Analyzed 16 participants 11 participants
NA [2]   (NA) 13.49  (3.670)
Week 10 Day 4 Number Analyzed 12 participants 8 participants
NA [2]   (NA) 19.07  (4.630)
Week 10 Day 7 Number Analyzed 13 participants 10 participants
NA [2]   (NA) 18.71  (4.111)
Week 12 Number Analyzed 12 participants 8 participants
NA [2]   (NA) 14.31  (3.438)
Week 14 Number Analyzed 16 participants 10 participants
4.78  (1.779) 7.07  (2.544)
Week 18 Number Analyzed 14 participants 9 participants
8.52  (4.338) 2.74  (1.737)
Week 22 Number Analyzed 14 participants 8 participants
10.79  (5.830) 1.18  (0.816)
Week 24 Number Analyzed 13 participants 7 participants
11.37  (6.177) 0.88  (0.599)
Week 38 Number Analyzed 9 participants 6 participants
0.41  (0.525) 0.02  (0.051)
[1]
Data could not be analyzed as the values were below lower limit of quantification (LLOQ) (0.0977 microgram per milliliter).
[2]
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
5.Secondary Outcome
Title Serum Sirukumab Concentrations Through Week 38 (Part B)
Hide Description Sirukumab Concentrations in serum were measured.
Time Frame Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.
Arm/Group Title Part B: Placebo Part B: Sirukumab 100 mg q2 Weeks Part B: Sirukumab 100 mg q4 Weeks Part B: Sirukumab 50 mg q4 Weeks Part B: Sirukumab 25 mg q4 Weeks
Hide Arm/Group Description:
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Overall Number of Participants Analyzed 26 30 30 30 31
Mean (Standard Deviation)
Unit of Measure: Microgram per milliliter
Week 0 Number Analyzed 25 participants 29 participants 30 participants 30 participants 31 participants
NA [1]   (NA) 0.03  (0.087) 0.00  (0.000) 0.02  (0.076) 0.01  (0.048)
Day 5 Number Analyzed 15 participants 22 participants 22 participants 15 participants 22 participants
NA [1]   (NA) 6.75  (3.212) 6.21  (2.933) 2.66  (1.447) 1.59  (0.808)
Day 8 Number Analyzed 22 participants 26 participants 28 participants 26 participants 31 participants
NA [1]   (NA) 5.67  (2.398) 5.85  (2.774) 2.61  (1.339) 1.49  (0.556)
Day 11 Number Analyzed 14 participants 20 participants 18 participants 13 participants 18 participants
0.02  (0.063) 4.50  (2.307) 4.68  (2.539) 2.54  (1.233) 1.26  (0.516)
Week 2 Number Analyzed 20 participants 24 participants 25 participants 25 participants 28 participants
NA [1]   (NA) 4.30  (2.265) 3.81  (1.934) 1.97  (0.916) 1.16  (0.426)
Week 4 Number Analyzed 25 participants 27 participants 26 participants 25 participants 28 participants
NA [1]   (NA) 7.16  (3.290) 2.02  (1.073) 0.97  (0.470) 0.85  (1.167)
Week 8 Number Analyzed 24 participants 23 participants 20 participants 18 participants 24 participants
NA [1]   (NA) 10.54  (5.008) 3.08  (1.806) 1.45  (0.764) 0.99  (0.560)
Week 12 Number Analyzed 22 participants 24 participants 19 participants 18 participants 24 participants
NA [1]   (NA) 11.63  (5.232) 3.10  (1.633) 1.79  (0.836) 0.99  (0.478)
Week 16 Number Analyzed 20 participants 22 participants 14 participants 14 participants 23 participants
6.84  (2.270) 9.96  (5.107) 3.51  (2.545) 2.03  (1.366) 0.98  (0.425)
Week 20 Number Analyzed 20 participants 21 participants 15 participants 15 participants 21 participants
9.94  (3.646) 10.29  (4.951) 3.92  (2.665) 1.80  (1.030) 1.03  (0.496)
Week 24 Number Analyzed 18 participants 17 participants 14 participants 13 participants 19 participants
11.04  (4.607) 10.73  (5.182) 3.80  (2.815) 1.89  (1.042) 1.04  (0.491)
Week 24 Day 4 Number Analyzed 9 participants 9 participants 12 participants 9 participants 13 participants
16.46  (6.826) 17.34  (9.046) 9.06  (5.632) 4.42  (1.293) 3.36  (1.578)
Week 24 Day 7 Number Analyzed 14 participants 15 participants 11 participants 11 participants 15 participants
15.14  (5.991) 15.01  (7.853) 9.58  (5.721) 4.52  (1.719) 2.80  (1.580)
Week 26 Number Analyzed 10 participants 10 participants 9 participants 7 participants 15 participants
10.97  (4.565) 10.09  (6.808) 6.49  (5.401) 3.72  (1.434) 1.91  (1.009)
Week 28 Number Analyzed 16 participants 15 participants 13 participants 14 participants 19 participants
6.93  (3.378) 6.69  (4.329) 4.15  (2.830) 1.84  (0.764) 1.06  (0.539)
Week 30 Number Analyzed 17 participants 16 participants 13 participants 14 participants 18 participants
4.49  (2.708) 4.06  (2.341) 2.42  (1.931) 1.07  (0.529) 0.52  (0.335)
Week 34 Number Analyzed 14 participants 16 participants 14 participants 12 participants 17 participants
1.88  (1.451) 1.92  (1.403) 0.94  (0.948) 0.39  (0.396) 0.10  (0.138)
Week 38 Number Analyzed 16 participants 15 participants 14 participants 13 participants 18 participants
0.71  (0.756) 0.72  (0.704) 0.29  (0.382) 0.08  (0.114) 0.01  (0.037)
[1]
Data could not be analyzed as the values were below LLOQ (0.0977 microgram per milliliter).
6.Secondary Outcome
Title Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)
Hide Description Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Part B: Placebo Part B: Sirukumab 100 mg q2 Weeks Part B: Sirukumab 100 mg q4 Weeks Part B: Sirukumab 50 mg q4 Weeks Part B: Sirukumab 25 mg q4 Weeks Part A: Placebo Part A: Sirukumab 100 mg q2 Weeks
Hide Arm/Group Description:
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22.
Overall Number of Participants Analyzed 30 30 30 30 31 17 14
Mean (Standard Deviation)
Unit of Measure: Percent change
-49.31  (246.040) 81.46  (25.000) 88.53  (12.675) 85.42  (18.242) 81.22  (24.484) 19.97  (41.232) 91.19  (4.812)
Time Frame Screening up to Week 38
Adverse Event Reporting Description Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings).
 
Arm/Group Title Part A - Placebo (Wk 0-Wk 12) Part A - Placebo Then Sirukumab (Wk 12 to End of Study) Part A - Sirukumab (Wk 0-Wk 12) Part A - Sirukumab Then Placebo (Wk 12 to End of Study) Part B - Placebo (Wk 0-Wk 12) Part B - Placebo Then Sirukumab 100 mg q2 Weeks Part B - Sirukumab 100mg q2w Part B - Sirukumab 100mg q4w Part B - Sirukumab 50mg q4w Part B - Sirukumab 25mg q4w
Hide Arm/Group Description Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Participants received placebo at Weeks 12 and q2w through Week 22. Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks. Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24. Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22.
All-Cause Mortality
Part A - Placebo (Wk 0-Wk 12) Part A - Placebo Then Sirukumab (Wk 12 to End of Study) Part A - Sirukumab (Wk 0-Wk 12) Part A - Sirukumab Then Placebo (Wk 12 to End of Study) Part B - Placebo (Wk 0-Wk 12) Part B - Placebo Then Sirukumab 100 mg q2 Weeks Part B - Sirukumab 100mg q2w Part B - Sirukumab 100mg q4w Part B - Sirukumab 50mg q4w Part B - Sirukumab 25mg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Part A - Placebo (Wk 0-Wk 12) Part A - Placebo Then Sirukumab (Wk 12 to End of Study) Part A - Sirukumab (Wk 0-Wk 12) Part A - Sirukumab Then Placebo (Wk 12 to End of Study) Part B - Placebo (Wk 0-Wk 12) Part B - Placebo Then Sirukumab 100 mg q2 Weeks Part B - Sirukumab 100mg q2w Part B - Sirukumab 100mg q4w Part B - Sirukumab 50mg q4w Part B - Sirukumab 25mg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/18 (0.00%)   1/17 (5.88%)   0/16 (0.00%)   4/30 (13.33%)   2/26 (7.69%)   2/30 (6.67%)   5/30 (16.67%)   1/30 (3.33%)   3/31 (9.68%) 
Eye disorders                     
Blindness * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Infections and infestations                     
Appendicitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Arthritis Bacterial * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Bursitis Infective * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Cellulitis Staphylococcal * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Pelvic Inflammatory Disease * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Pneumonia * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Pyelonephritis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Investigations                     
Transaminases Increased * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Rheumatoid Arthritis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Fibrosarcoma * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Nervous system disorders                     
Facial Paresis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Intracranial Aneurysm * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Subarachnoid Haemorrhage * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Vertebral Artery Occlusion * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Reproductive system and breast disorders                     
Uterine Polyp * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders                     
Skin Ulcer * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA: 13.0,13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A - Placebo (Wk 0-Wk 12) Part A - Placebo Then Sirukumab (Wk 12 to End of Study) Part A - Sirukumab (Wk 0-Wk 12) Part A - Sirukumab Then Placebo (Wk 12 to End of Study) Part B - Placebo (Wk 0-Wk 12) Part B - Placebo Then Sirukumab 100 mg q2 Weeks Part B - Sirukumab 100mg q2w Part B - Sirukumab 100mg q4w Part B - Sirukumab 50mg q4w Part B - Sirukumab 25mg q4w
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/19 (63.16%)   18/18 (100.00%)   12/17 (70.59%)   10/16 (62.50%)   15/30 (50.00%)   11/26 (42.31%)   20/30 (66.67%)   18/30 (60.00%)   25/30 (83.33%)   23/31 (74.19%) 
Blood and lymphatic system disorders                     
Haemorrhagic Diathesis * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Leukopenia * 1  0/19 (0.00%)  1/18 (5.56%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  3/26 (11.54%)  4/30 (13.33%)  4/30 (13.33%)  5/30 (16.67%)  3/31 (9.68%) 
Neutropenia * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  2/30 (6.67%)  2/30 (6.67%)  0/31 (0.00%) 
Thrombocytopenia * 1  0/19 (0.00%)  2/18 (11.11%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  1/30 (3.33%)  0/30 (0.00%)  1/31 (3.23%) 
Cardiac disorders                     
Bundle Branch Block Left * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Ear and labyrinth disorders                     
Tinnitus * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Vertigo * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Eye disorders                     
Eye Pain * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Uveitis * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Vision Blurred * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Gastrointestinal disorders                     
Abdominal Pain * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  2/30 (6.67%)  1/30 (3.33%)  1/30 (3.33%)  0/31 (0.00%) 
Abdominal Pain Upper * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  2/30 (6.67%)  1/31 (3.23%) 
Aphthous Stomatitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  2/30 (6.67%)  1/30 (3.33%)  1/30 (3.33%)  0/31 (0.00%) 
Colitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  3/31 (9.68%) 
Diarrhoea * 1  1/19 (5.26%)  0/18 (0.00%)  3/17 (17.65%)  0/16 (0.00%)  1/30 (3.33%)  1/26 (3.85%)  2/30 (6.67%)  0/30 (0.00%)  1/30 (3.33%)  1/31 (3.23%) 
Dyspepsia * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  2/31 (6.45%) 
Periodontitis * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Stomatitis * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Vomiting * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
General disorders                     
Fatigue * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Injection Site Erythema * 1  0/19 (0.00%)  4/18 (22.22%)  6/17 (35.29%)  0/16 (0.00%)  1/30 (3.33%)  2/26 (7.69%)  3/30 (10.00%)  2/30 (6.67%)  4/30 (13.33%)  6/31 (19.35%) 
Injection Site Pain * 1  1/19 (5.26%)  1/18 (5.56%)  4/17 (23.53%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Injection Site Pruritus * 1  0/19 (0.00%)  0/18 (0.00%)  2/17 (11.76%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Injection Site Rash * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  2/30 (6.67%)  0/31 (0.00%) 
Injection Site Swelling * 1  0/19 (0.00%)  1/18 (5.56%)  2/17 (11.76%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Injection Site Urticaria * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Injection Site Warmth * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Pyrexia * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Hepatobiliary disorders                     
Hepatitis * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Infections and infestations                     
Acute Tonsillitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  0/31 (0.00%) 
Bronchitis * 1  2/19 (10.53%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Gastroenteritis * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  1/30 (3.33%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/31 (0.00%) 
Herpes Zoster * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Lymphangitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Nasopharyngitis * 1  1/19 (5.26%)  2/18 (11.11%)  2/17 (11.76%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  5/30 (16.67%)  0/30 (0.00%)  1/30 (3.33%)  2/31 (6.45%) 
Pharyngitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  2/30 (6.67%)  1/30 (3.33%)  2/30 (6.67%)  2/31 (6.45%) 
Pneumonia * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Rhinitis * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Sinusitis * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  2/30 (6.67%)  1/31 (3.23%) 
Staphylococcal Skin Infection * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Upper Respiratory Tract Infection * 1  2/19 (10.53%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  3/30 (10.00%)  3/30 (10.00%)  2/31 (6.45%) 
Injury, poisoning and procedural complications                     
Synovial Rupture * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Investigations                     
Alanine Aminotransferase Increased * 1  0/19 (0.00%)  4/18 (22.22%)  2/17 (11.76%)  0/16 (0.00%)  1/30 (3.33%)  1/26 (3.85%)  4/30 (13.33%)  7/30 (23.33%)  10/30 (33.33%)  6/31 (19.35%) 
Aspartate Aminotransferase Increased * 1  0/19 (0.00%)  0/18 (0.00%)  2/17 (11.76%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  3/30 (10.00%)  4/30 (13.33%)  6/30 (20.00%)  3/31 (9.68%) 
Blood Bilirubin Increased * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  1/31 (3.23%) 
Blood Cholesterol Increased * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  3/30 (10.00%)  1/30 (3.33%)  1/31 (3.23%) 
Blood Glucose Increased * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Blood Insulin Increased * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  3/30 (10.00%)  0/31 (0.00%) 
Blood Potassium Decreased * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  2/16 (12.50%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Haemoglobin Decreased * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  2/30 (6.67%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Insulin Resistance Test * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  3/30 (10.00%)  0/31 (0.00%) 
Intraocular Pressure Increased * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Transaminases Increased * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  1/26 (3.85%)  1/30 (3.33%)  0/30 (0.00%)  1/30 (3.33%)  2/31 (6.45%) 
White Blood Cell Count Decreased * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  1/26 (3.85%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  2/31 (6.45%) 
Metabolism and nutrition disorders                     
Hypercholesterolaemia * 1  1/19 (5.26%)  1/18 (5.56%)  5/17 (29.41%)  2/16 (12.50%)  1/30 (3.33%)  0/26 (0.00%)  5/30 (16.67%)  1/30 (3.33%)  2/30 (6.67%)  4/31 (12.90%) 
Hyperlipidaemia * 1  0/19 (0.00%)  1/18 (5.56%)  1/17 (5.88%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  1/31 (3.23%) 
Hypokalaemia * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  1/16 (6.25%)  1/30 (3.33%)  1/26 (3.85%)  2/30 (6.67%)  1/30 (3.33%)  1/30 (3.33%)  0/31 (0.00%) 
Intervertebral Disc Degeneration * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Musculoskeletal Chest Pain * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  1/31 (3.23%) 
Musculoskeletal Pain * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Neck Pain * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Pain in Extremity * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  1/31 (3.23%) 
Rheumatoid Arthritis * 1  2/19 (10.53%)  1/18 (5.56%)  1/17 (5.88%)  2/16 (12.50%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  3/30 (10.00%)  1/31 (3.23%) 
Spinal Column Stenosis * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Tendon Pain * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Nervous system disorders                     
Dizziness * 1  1/19 (5.26%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  3/30 (10.00%)  1/26 (3.85%)  0/30 (0.00%)  1/30 (3.33%)  0/30 (0.00%)  0/31 (0.00%) 
Headache * 1  1/19 (5.26%)  1/18 (5.56%)  0/17 (0.00%)  1/16 (6.25%)  2/30 (6.67%)  1/26 (3.85%)  2/30 (6.67%)  1/30 (3.33%)  1/30 (3.33%)  2/31 (6.45%) 
Migraine * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Sciatica * 1  0/19 (0.00%)  1/18 (5.56%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Psychiatric disorders                     
Anxiety * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  1/30 (3.33%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Upper Respiratory Tract Inflammation * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  1/30 (3.33%)  2/26 (7.69%)  0/30 (0.00%)  1/30 (3.33%)  1/30 (3.33%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders                     
Dry Skin * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Rash * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Urticaria * 1  0/19 (0.00%)  0/18 (0.00%)  1/17 (5.88%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  1/31 (3.23%) 
Vascular disorders                     
Haematoma * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  0/30 (0.00%)  0/26 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
Hypertension * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  1/16 (6.25%)  2/30 (6.67%)  0/26 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  0/30 (0.00%)  3/31 (9.68%) 
Thrombophlebitis * 1  0/19 (0.00%)  0/18 (0.00%)  0/17 (0.00%)  0/16 (0.00%)  0/30 (0.00%)  0/26 (0.00%)  2/30 (6.67%)  0/30 (0.00%)  0/30 (0.00%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA: 13.0,13.1
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
Layout table for Results Point of Contact information
Name/Title: Associate Director
Organization: Janssen Research & Development, LLC
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00718718    
Other Study ID Numbers: CR015214
C1377T04 ( Other Identifier: Centocor )
2007-006603-20 ( EudraCT Number )
First Submitted: July 17, 2008
First Posted: July 21, 2008
Results First Submitted: October 22, 2017
Results First Posted: December 4, 2017
Last Update Posted: January 23, 2018