Status:
COMPLETED
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00254293
Start Date
January 1 2006
End Date
July 1 2012
Last Update
April 8 2014
Active Locations (5)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32806
2
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
3
New Orleans Center For Clinical Research
New Orleans, Louisiana, United States, 70119
4
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404