drugset
drugset / Trial / NCT00819585

A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

NCT00819585 ↗

Phase 2 Completed 432 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2008-12
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Canakinumab Monoclonal antibody 25 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 50 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 100 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 200 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 300 mg Subcutaneous
Subject Colchicine Small molecule 0.5 mg Oral
Background Allopurinol Small molecule 100 mg Oral
Background Allopurinol Small molecule 300 mg Oral

Indications

gout