Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.
Completed · Phase 3 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.
Key facts
- Study ID
- NCT00048581
- Run by
- Bristol-Myers Squibb
- People needed
- 738
- Starts
- 2002-12-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2011-11-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Women who are pregnant or breast feeding
- Current symptoms of serious medical disease
- History of cancer in last 5 years other than non-melanoma skin cancer
- Chronic serious infection
- Active TB requiring treatment in last 5 years
- Herpes zoster in last 2 months
- Any active viral infection including Human Immunodeficiency Virus (HIV)
- Serious side effects associated with previous anti-TNF therapy
Where it is running
- Local Institution — Birmingham, Alabama, United States
- Local Institution — Mobile, Alabama, United States
- Local Institution — Paradise Valley, Arizona, United States
- Local Institution — La Jolla, California, United States
- Local Institution — Long Beach, California, United States
- Local Institution — Palo Alto, California, United States
- Local Institution — Rancho Mirage, California, United States
- Local Institution — Denver, Colorado, United States
- Local Institution — Englewood, Colorado, United States
- Local Institution — Bridgeport, Connecticut, United States
- Local Institution — Hamden, Connecticut, United States
- Local Institution — Clearwater, Florida, United States
- Local Institution — Fort Lauderdale, Florida, United States
- Local Institution — Largo, Florida, United States
- Local Institution — Palm Harbor, Florida, United States
- Local Institution — Tampa, Florida, United States
- Local Institution — Rome, Georgia, United States
- Local Institution — Indianapolis, Indiana, United States
- Local Institution — Wichita, Kansas, United States
- Local Institution — New Orleans, Louisiana, United States
- Local Institution — Boston, Massachusetts, United States
- Local Institution — Springfield, Massachusetts, United States
- Local Institution — Lincoln, Nebraska, United States
- Local Institution — New Brunswick, New Jersey, United States
- Local Institution — Albany, New York, United States
Full record on ClinicalTrials.gov
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