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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

Key facts

Study ID

NCT00124982

Run by

Bristol-Myers Squibb

People needed

1286

Starts

2005-04-01

Expected to finish

2009-08-01

Last updated by the study team

2012-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Local Institution — Huntsville, Alabama, United States
• Local Institution — Paradise Valley, Arizona, United States
• Local Institution — Peoria, Arizona, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Palm Springs, California, United States
• Local Institution — Palo Alto, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Santa Monica, California, United States
• Local Institution — Colorado Springs, Colorado, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Danbury, Connecticut, United States
• Local Institution — Hamden, Connecticut, United States
• Local Institution — Trumbull, Connecticut, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Aventura, Florida, United States
• Local Institution — Clearwater, Florida, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Jupiter, Florida, United States
• Local Institution — Largo, Florida, United States
• Local Institution — Sarasota, Florida, United States
• Local Institution — Atlanta, Georgia, United States
• Local Institution — Blue Ridge, Georgia, United States
• Local Institution — Macon, Georgia, United States
• Local Institution — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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