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Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy (RACAT)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Rheumatoid Arthritis Investigational Network (RAIN)
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00405275
First received: November 29, 2006
Last updated: November 7, 2013
Last verified: November 2013
Results First Received: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Etanercept
Drug: methotrexate
Drug: Sulfasalazine
Drug: Hydroxychloroquine
Drug: Placebo, triple
Drug: Placebo, etanercept

  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
Bi-national, multi-center 3.5 year recruitment at 16 VA, 12 RAIN and 8 Canadian medical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Triple

Hydroxychloroquine (400mg daily); Sulfasalazine (1g daily for 6 weeks, then increased to 2g daily; Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, etanercept (subcutaneous injection).

Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Etanercept at 24 weeks. This is denoted in results table below as "switch". "No switch" participants remained on Triple therapy throughout the trial.

Etanercept

Etanercept (50mg subcutaneous injections weekly); Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, triple: placebo hydroxychloroquine (tablets daily) and placebo sulfasalazine (tablets daily).

Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Triple. This is denoted in results table below as "switch". "No switch" participants remained on Etanercept therapy throughout the trial.


Participant Flow:   Overall Study
    Triple     Etanercept  
STARTED     178     175  
24 Weeks (Total)     163     165  
24 Week (no Switch)     119     121  
24 Week (Switch)     44     44  
COMPLETED     155     156  
NOT COMPLETED     23     19  
Death                 1                 0  
Lost to Follow-up                 5                 1  
Withdrawal by Subject                 7                 9  
Unwilling to continue                 10                 9  



  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
Triple Hydroxychloroquine, sulfasalazine and methotrexate
Etanercept Etanercept and Methotrexate
Total Total of all reporting groups

Baseline Measures
    Triple     Etanercept     Total  
Number of Participants  
[units: participants]
  178     175     353  
Age  
[units: years]
Mean ± Standard Deviation
  57.8  ± 13.0     56.0  ± 13.2     56.9  ± 13.1  
Gender, Customized  
[units: participants]
     
Female     77     85     162  
Male     101     89     190  
Unknown     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     134     130     264  
Canada     44     45     89  



  Outcome Measures

1.  Primary:   Mean 48-week Change in DAS28   [ Time Frame: 48 weeks after baseline assessment ]


  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 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: James R. O'Dell, MD
Organization: VA Nebraska-Western Iowa Health Care System
phone: 402-559-7288
e-mail: jrodell@unmc.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00405275     History of Changes
Other Study ID Numbers: 551, Y1-AR-0048-01
Study First Received: November 29, 2006
Results First Received: June 5, 2013
Last Updated: November 7, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration