At a glance
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A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare
In Brief
A Phase 2 clinical trial evaluating Canakinumab, Colchicine, and 3 other interventions for Gout. Completed, enrolled 432 participants across 89 sites in 18 countries.
Detailed Summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Study Details
Timeline
Interventions
Canakinumab was supplied in glass vials as a lyophilized powder.
0.5 mg capsule orally once daily for 16 weeks.
100-300 mg orally once daily for 24 weeks.
Subcutaneous injection.
Capsule orally once daily for 16 weeks.