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About
The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.
The purpose of the first 12-week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2356.
The purpose of the second 48 week open-label extension study was to collect additional long-term safety and tolerability data in patients who have completed the first extension study CACZ885H2356E1.
Full description
Masking:
Core: Double Blind (Subject, Investigator) Extension 1: Double Blind (Subject, Investigator) Extension 2: Open-label, terminated
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Core Study:
Inclusion criteria:
Exclusion criteria:
Extension Study 1:
Inclusion Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.
Exclusion
Extension Study 2:
Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).
Exclusion
-Continuation in this extension study was considered inappropriate by the treating physician
Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.
Primary purpose
Allocation
Interventional model
Masking
230 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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