Overview
Phase IIIB Subcutaneous Missed Dose Study
Status:
Completed
Completed
Trial end date:
2014-02-01
2014-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Abatacept
Criteria
Inclusion Criteria:- Clinical diagnosis of Rheumatoid Arthritis
- Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
- On background methotrexate at least 3 months (≥10mg weekly)
- Must be able to self injection or allow a care giver to do it for them
- Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except
for methotrexate
Exclusion Criteria:
- Participants who had prior exposure to abatacept or CTLA-4 Ig
- Received treatment with rituximab.
- Participants who have received treatment with leflunomide within 1 year of screening
- Participants who have received treatment with immunoadsorption columns (such as
Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other
calcineurin inhibitors, or D-Penicillamine.