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.

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Antirheumatic Agents

Criteria

Eligibility Criteria:

• Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF therapy in the past.

Exclusion Criteria:

• 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