Abatacept Versus Adalimumab Head-to-Head

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria

• Methotrexate failure

• Naive to RA biologics

• ≤5 years duration of disease

• Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2

• Willingness to self-inject subcutaneous (SC) drug

Exclusion Criteria:

• Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents

• History of active or chronic hepatitis

• Cancer in the last 5 years

• History of severe chronic or recurrent bacterial or viral infections

• Risk of tuberculosis

• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease