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 and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
738 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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