NCT01029652

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 Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

A 12 Weeks Randomized, Controlled Core 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-week Double-blind Extension Study and an Open-label 48 Week Extension Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Masking: Core: Double Blind (Subject, Investigator) Extension 1: Double Blind (Subject, Investigator) Extension 2: Open-label, terminated

Conditions

• Acute Gout

Interventions

Type	Name	Description
DRUG	Canakinumab 150 mg	Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
DRUG	Triamcinolone acetonide 40 mg	Triamcinolone acetonide 40 mg was supplied as a suspension.
DRUG	Placebo to canakinumab	Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.
DRUG	Placebo to triamcinolone acetonide	Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-12-10
• Last updated: 2014-01-30
• Results posted: 2011-11-18

Locations

47 sites across 17 countries: Australia, Belgium, Canada, Colombia, Estonia, Germany, Guatemala, Latvia, Lithuania, Mexico, Norway, Poland, Russia, Singapore, Sweden, Switzerland, Ukraine