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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00254293

Run by

Bristol-Myers Squibb

People needed

87

Starts

2006-01-01

Expected to finish

2012-07-01

Last updated by the study team

2014-04-08

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• New Orleans Center For Clinical Research — New Orleans, Louisiana, United States
• Davita Clinical Research — Minneapolis, Minnesota, United States
• The Arthritis Clinic & Carolina Bone & Joint — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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