A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study
A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study
The purpose of this 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 CACZ885H2357.
The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.
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:
- Continuation in this extension study was considered inappropriate by the treating physician.
Extension Study 2:
Inclusion Criteria:
Exclusion Criteria:
-Continuation in this second extension study was considered inappropriate by the treating physician.
Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.
Long Beach, California 90806, United States
Bumberland, Rhode Island 02864, United States
North Richard Hills, Texas 76180, United States
Kaohsiung Hsien, Taiwan, China
Kaohsiung, Taiwan, China
Taichung, Taiwan, China
Taipei, Taiwan, China