NCT01362608

Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Conditions

• Gouty Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab, ACZ885	Canakinumab and placebo matching to triamcinolone acetonide
DRUG	Triamcinolone acetonide	Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Timeline

• Start date: 2011-06-20
• Primary completion: 2015-05-19
• Completion: 2015-05-19
• First posted: 2011-05-30
• Last updated: 2017-06-08
• Results posted: 2017-06-08

Locations

20 sites across 4 countries: Argentina, China, Poland, Singapore