Status:
COMPLETED
Abatacept Versus Adalimumab Head-to-Head
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
- Methotrexate failure
- Naive to RA biologics
- ≤5 years duration of disease
- Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
- Willingness to self-inject subcutaneous (SC) drug
Exclusion
- Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
- History of active or chronic hepatitis
- Cancer in the last 5 years
- History of severe chronic or recurrent bacterial or viral infections
- Risk of tuberculosis
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
869 Patients enrolled
Trial Details
Trial ID
NCT00929864
Start Date
October 1 2009
End Date
November 1 2012
Last Update
February 4 2014
Active Locations (83)
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1
Rheumatology Associates, Pc
Birmingham, Alabama, United States, 35205
2
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
3
Clinical And Translational Research Center Of Alabama, Pc
Tuscaloosa, Alabama, United States, 35406
4
Sun Valley Arthritis Center, Ltd.
Peoria, Arizona, United States, 85381