Methotrexate - Inadequate Response Device Sub-Study

Sub-study-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.

Inclusion Criteria:

• Men and women, ages ≥ 18
• Participants who are considered methotrexate inadequate responders (MTX-IR)
• 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
• Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period

Exclusion Criteria:

• Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies
• Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus)
• Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
• Participants with severe chronic or recurrent bacterial infections
• Participants who have received treatment with rituximab