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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Part A - Placebo (Wk 0-Wk 12) Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks.
Part A - Placebo Then Sirukumab (Wk 12 to End of Study) 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.
Part A - Sirukumab (Wk 0-Wk 12) Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10.
Part A - Sirukumab Then Placebo (Wk 12 to End of Study) Participants received placebo at Weeks 12 and q2w through Week 22.
Part B - Placebo (Wk 0-Wk 12) Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks.
Part B - Placebo Then Sirukumab 100 mg q2 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.
Part B - Sirukumab 100mg q2w Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
Part B - Sirukumab 100mg q4w 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.
Part B - Sirukumab 50mg q4w 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.
Part B: Sirukumab 25 mg q4 Weeks Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.

Participant Flow for 2 periods

Period 1:   Prior to Week 12
    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
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 
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 2:   Week 12 to End of Study
    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
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 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Part A: Placebo Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22.
Part A: Sirukumab 100 mg q2 Weeks Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22.
Part B: Placebo Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24.
Part B: Sirukumab 100 mg q2 Weeks Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24.
Part B: Sirukumab 100 mg q4 Weeks Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Part B: Sirukumab 50 mg q4 Weeks Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Part B: Sirukumab 25 mg q4 Weeks Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22.
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 19   17   30   30   30   30   31   187 
Age 
[Units: Years]
Mean (Standard Deviation)
 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 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
               
Hungary   0   0   2   5   3   3   4   17 
Japan   0   0   5   5   5   6   6   27 
Mexico   0   0   5   3   4   5   6   23 
Poland   13   12   9   10   6   5   7   62 
Republic of Korea   0   0   0   1   1   2   1   5 
Russian Federation   0   0   9   6   10   9   7   41 
United States   6   5   0   0   1   0   0   12 


  Outcome Measures

1.  Primary:   Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)   [ Time Frame: Week 12 ]

2.  Secondary:   Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)   [ Time Frame: Week 12 ]

4.  Secondary:   Serum Sirukumab Concentrations Through Week 38 (Part A)   [ 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 ]

5.  Secondary:   Serum Sirukumab Concentrations Through Week 38 (Part B)   [ 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 ]

6.  Secondary:   Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)   [ Time Frame: Baseline, Week 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00718718     History of Changes
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