Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Meet ARA criteria for diagnosis of RA with active disease.

• RA diagnosis for at least 1 year.

• > = 6 swollen joints.

• > = 8 tender joints.

• Taking methotrexate (MTX) or MTX plus not more than 1 added oral DMARD for > = 3 months and stable for 28 days prior to dosing.

Exclusion Criteria:

• Serious acute or bacterial infection in last 3 months.

• Chronic or recurrent bacterial infections.

• History of TB within previous 3 years or old TB not adequately treated.

• Specific lab test abnormalities

• History of cancer within 5 years.

• Exposure to CTLA4Ig (Cytotoxic T-lymphocyte (T-cell)-associated antigen 4Ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.

• Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.

• Exposure to live vaccines.