Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

Key Inclusion Criteria:

• Subjects ≥18 years of age

• Diagnosis of Rheumatoid Arthritis confirmed by participant's physician

• Disease activity under control

Key Exclusion Criteria:

• Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of enrollment

• Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer

• Current or prior use of Rituximab ≤6 months

• Current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil & d-Penicillamine