Status:
COMPLETED
Methotrexate - Inadequate Response Device Sub-Study
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.
Eligibility Criteria
Inclusion
- Men and women, ages ≥ 18
- Participants who are considered methotrexate inadequate responders (MTX-IR)
- 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
- Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period
Exclusion
- Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies
- Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus)
- Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
- Participants with severe chronic or recurrent bacterial infections
- Participants who have received treatment with rituximab
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01173120
Start Date
November 1 2009
End Date
July 1 2010
Last Update
January 12 2012
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