Conditions: Gouty Arthritis
Keywords: Gout Inflammatory gout acute gout
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 136
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: ACZ885H arm 2: ACZ885H

Interventions: intervention 1: Canakinumab, ACZ885 intervention 2: Triamcinolone acetonide
Intervention descriptions: intervention 1: Canakinumab and placebo matching to triamcinolone acetonide intervention 2: Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Protocol document: