Status:
COMPLETED
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumati...
Eligibility Criteria
Inclusion
- Completed double-blind portion of the IM101064 study.
- Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
- American College of Rheumatology (ACR) functional class I, II, III
- Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months
Exclusion
- Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
- History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1286 Patients enrolled
Trial Details
Trial ID
NCT00124982
Start Date
April 1 2005
End Date
August 1 2009
Last Update
February 27 2012
Active Locations (148)
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1
Local Institution
Birmingham, Alabama, United States
2
Local Institution
Huntsville, Alabama, United States
3
Local Institution
Paradise Valley, Arizona, United States
4
Local Institution
Peoria, Arizona, United States