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Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01248780
First received: November 24, 2010
Last updated: August 12, 2013
Last verified: August 2013
Results First Received: October 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Golimumab
Drug: Placebo
Drug: Methotrexate (MTX)

  Participant Flow
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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
In this trial, 264 participants were randomly assigned to the 2 treatment arms.

Reporting Groups
  Description
Group I: Placebo + MTX -> Golimumab 50 mg + MTX Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
Group II: Golimumab 50 mg + MTX Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).

Participant Flow:   Overall Study
    Group I: Placebo + MTX -> Golimumab 50 mg + MTX     Group II: Golimumab 50 mg + MTX  
STARTED     132     132  
COMPLETED     123     117  
NOT COMPLETED     9     15  
Lack of Efficacy                 2                 0  
Lost to Follow-up                 0                 1  
Death                 0                 1  
Adverse Event                 2                 7  
Protocol Violation                 1                 1  
Withdrawal by Subject                 4                 4  
Not treated                 0                 1  



  Baseline Characteristics
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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
Group I: Placebo + MTX -> Golimumab 50 mg + MTX Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
Group II: Golimumab 50 mg + MTX Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
Total Total of all reporting groups

Baseline Measures
    Group I: Placebo + MTX -> Golimumab 50 mg + MTX     Group II: Golimumab 50 mg + MTX     Total  
Number of Participants  
[units: participants]
  132     132     264  
Age  
[units: years]
Mean ± Standard Deviation
  46.7  ± 12.16     47.7  ± 11.46     47.2  ± 11.81  
Gender  
[units: participants]
     
Female     104     110     214  
Male     28     22     50  



  Outcome Measures
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1.  Primary:   American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14   [ Time Frame: Week 14 ]

2.  Secondary:   Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)   [ Time Frame: Week 14 ]

3.  Secondary:   American College of Rheumatology 20 Response, Using CRP, at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline   [ Time Frame: Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Research
Organization: Janssen Research & Development
phone: 610-500-3369


No publications provided


Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01248780     History of Changes
Other Study ID Numbers: CR015913, C0524T28
Study First Received: November 24, 2010
Results First Received: October 5, 2012
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board