Rheumatoid Arthritis Clinical Trial
Official title:
A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose
regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to
7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The
study investigated the magnitude of effect as well as onset of effect for the different dose
regimens.
The primary objective of the extension studies was to assess long-term safety and
tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated
this objective in patients who had participated in the core study (CACZ885A2201) and
CACZ885A2201E2 did the same in patients who completed the first extension study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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