Abatacept Versus Adalimumab Head-to-Head
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT00929864
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Abatacept — DRUGSyringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
- Adalimumab — DRUGSyringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Study Details
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive
Key Dates
- Start date
- Oct 31, 2009
- Status verified
- Jan 2014
- Primary completion
- Oct 31, 2011
- Completion
- Nov 30, 2012
Study Design
- Enrollment
- 869 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Abatacept
- Active Comparator: Adalimumab
Primary Outcome Measure
The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population [ Time Frame: Day 1 to Day 365 ]
Locations (63)
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By research site
Rheumatology Associates, Pc· Birmingham, ALUniversity Of Alabama At Birmingham· Birmingham, ALClinical And Translational Research Center Of Alabama, Pc· Tuscaloosa, ALSun Valley Arthritis Center, Ltd.· Peoria, AZMercy Clinic Hot Springs Communities· Hot Springs, ARTalbert Medical Group· Huntington Beach, CA
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