Conditions: Acute Gouty Arthritis
Keywords: Gout arthritis gout flare acute gout gouty rheumatic disease uric acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 397
Healthy volunteers: no

Brief summary:
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Detailed description:

Arms:
arm 1: Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. arm 2: The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. arm 3: The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

Interventions: intervention 1: Canakinumab pre-filled syringe intervention 2: Canakinumab lyophilized powder intervention 3: Triamcinolone Acetonide intervention 4: Placebo
Intervention descriptions: intervention 1: Canakinumab pre-filled syringe intervention 2: Canakinumab lyophilized powder intervention 3: Triamcinolone Acetonide intervention 4: Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide

Protocol document: