At a glance
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A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate
In Brief
A Phase 3 clinical trial evaluating Abatacept and Placebo for Active Rheumatoid Arthritis. Completed, enrolled 50 participants across 10 sites in 6 countries.
Detailed Summary
The only trial in participants who are methotrexate-inadequate responders and have active Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism-of-action information on how Abatacept exerts its effects (including on bone) through new techniques.
Study Details
Timeline
Interventions
Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment
Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment