Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
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This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.
A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis
Study Start Date
Primary Completion Date
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• Adverse events and infections • Vital signs and body measurements, hematology, blood chemistry, and urinalysis • Physical examination • Antinuclear antibody (ANA) assessment • Electrocardiogram (ECG) evaluation [ Time Frame: throughout the study ]
Secondary Outcome Measures
• Response to treatment according to ACR20, ACR50, ACR70, and ACR90 and SDAI and DAS28. • Effect on ACR components. • Long-term immunogenicity. • Long-term pharmacokinetics of ACZ885. • Long term maintenance of health-related quality of life [ Time Frame: throughout the study ]
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent
Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
Patients who were non-compliant or who demonstrated a major protocol violation in the core study.
Patients who did not complete / discontinued from the core study.
Patients with drug related serious adverse events or severe adverse events.
Other protocol-defined inclusion/exclusion criteria may apply.