A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Completed
Bristol-Myers Squibb
Phase 3
2002-12-01
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.
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
Bristol-Myers Squibb
Phase 3
2002-12-01
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.
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
Completed
Bristol-Myers Squibb
Phase 3
2002-12-01
The purpose of this clinical research study is to learn if abatacept is safe when
co-administered with other approved rheumatoid arthritis medications.
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Completed
Bristol-Myers Squibb
Phase 3
2005-02-01
The purpose of this clinical research study is to learn if Abatacept or Infliximab in
combination with Methotrexate demonstrate a greater reduction in disease activity over
placebo.
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