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Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine - NCT01137344-16635(Clinical Trial 652353)



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City:  Duncansville
State:  
PA
Zip Code: 16635
Conditions: Acute Gout
Purpose: The purpose of this extension study is to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357 to support the registration of canakinumab for the indication of gout.
Study summary:
Criteria: Inclusion Criteria: - Completion of the core study CACZ885H2357. A patient is defined as completing the core study if they completed the study up to and including Visit 7. - Meeting the ACR 1977 preliminary criteria for the classification of acute arthritis of primary gout - Onset of current acute gout flare within 5 days prior to study entry - Baseline pain intensity > or = 50 mm on the 0-100 mm VAS - History of > or = 3 gout flares within the 12 months prior to study entry - Contraindication, or intolerance, or lack of efficacy for NSAIDs and/or colchicine Exclusion Criteria: - Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis. - Presence of severe renal function impairment - Use of forbidden therapies - Live vaccinations within 3 months prior to randomization. - Requirement for administration of antibiotics against latent tuberculosis (TB) - Refractory heart failure (Stage D). - Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia Other protocol-defined inclusion/exclusion criteria may apply.
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Data Source: ClinicalTrials.gov
Date Processed: November 28, 2010
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