A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.

Key facts

Study ID

NCT00048568

Run by

Bristol-Myers Squibb

People needed

1250

Starts

2002-12-01

Expected to finish

2009-10-01

Last updated by the study team

2011-12-05

Who can join

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

Where it is running

• Local Institution — Birmingham, Alabama, United States
• Local Institution — Huntsville, Alabama, United States
• Local Institution — Mobile, Alabama, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Scottsdale, Arizona, United States
• Local Institution — Corona, California, United States
• Local Institution — Irvine, California, United States
• Local Institution — La Jolla, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Rancho Mirage, California, United States
• Local Institution — Aurora, Colorado, United States
• Local Institution — Colorado Springs, Colorado, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Hamden, Connecticut, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Gainsville, Florida, United States
• Local Institution — Palm Harbor, Florida, United States
• Local Institution — Sarasota, Florida, United States
• Local Institution — St. Petersburg, Florida, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Rockford, Illinois, United States
• Local Institution — Wichita, Kansas, United States
• Local Institution — Coeur d'Alene, Maryland, United States
• Local Institution — Cumberland, Maryland, United States

Full record on ClinicalTrials.gov

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