We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01689532
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

  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
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.

Reporting Groups
  Description
Sirukumab 50 Milligram (mg) Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
Sirukumab 100 mg Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.

Participant Flow:   Overall Study
    Sirukumab 50 Milligram (mg)   Sirukumab 100 mg
STARTED   61   61 
COMPLETED   47   52 
NOT COMPLETED   14   9 
Adverse Event                9                5 
Lack of Efficacy                2                2 
Withdrawal by Subject                1                2 
Physician Decision                2                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.
Baseline population included all randomized participants who received study drug.

Reporting Groups
  Description
Sirukumab 50 Milligram (mg) Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
Sirukumab 100 mg Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
Total Total of all reporting groups

Baseline Measures
   Sirukumab 50 Milligram (mg)   Sirukumab 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   61   122 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.4  (10.7)   54.7  (12.16)   55.1  (11.41) 
Gender 
[Units: Participants]
     
Female   47   43   90 
Male   14   18   32 
Region of Enrollment 
[Units: Participants]
     
JAPAN   61   61   122 


  Outcome Measures

1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (TEAE)   [ Time Frame: Baseline upto Week 68 ]

2.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response   [ Time Frame: At Weeks 16 and 24 ]

3.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response   [ Time Frame: At Weeks 16 and 24 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response   [ Time Frame: At Weeks 16 and 24 ]

5.  Secondary:   Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response   [ Time Frame: At Weeks 16 and 24 ]

6.  Secondary:   Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

7.  Secondary:   Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

8.  Secondary:   Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

9.  Secondary:   Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

10.  Secondary:   Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

11.  Secondary:   Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

12.  Secondary:   Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

13.  Secondary:   Percentage of Participants Who Achieved Major Clinical Response at Week 52   [ Time Frame: Week 52 ]

14.  Secondary:   Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24   [ Time Frame: At Weeks 16 and 24 ]

15.  Secondary:   Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24   [ Time Frame: At Week 24 ]

16.  Secondary:   Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

17.  Secondary:   Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52   [ Time Frame: At Weeks 16, 24 and 52 ]

18.  Secondary:   Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52   [ Time Frame: At Weeks 16, 24 and 52 ]

19.  Secondary:   Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

20.  Secondary:   Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

21.  Secondary:   Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24   [ Time Frame: Baseline, at Week 16 and 24 ]

22.  Secondary:   Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24   [ Time Frame: At Weeks 16 and 24 ]

23.  Secondary:   Percentage of Participants Maintaining HAQ-DI Response   [ Time Frame: Baseline upto Week 52 ]

24.  Secondary:   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   [ Time Frame: Baseline, Weeks 24 and 52 ]

25.  Secondary:   Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24   [ Time Frame: Baseline, Weeks 16 and 24 ]

26.  Secondary:   Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52   [ Time Frame: Baseline, Weeks 16, 24 and 52 ]

27.  Secondary:   Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52   [ Time Frame: Baseline, Weeks 16, 24 and 52 ]

28.  Secondary:   Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52   [ Time Frame: Baseline, Weeks 16, 24 and 52 ]

29.  Secondary:   Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52   [ Time Frame: Baseline, Weeks 16, 24 and 52 ]


  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: Senior Manager
Organization: Janssen Pharmaceutical K.K.
e-mail: ClinicalTrialDisclosure@its.jnj.com



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