Conditions: Arthritis, Gouty
Keywords: Arthritis Gouty ACZ885 IL1B protein Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Detailed description:

Arms:
arm 1: Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. arm 2: Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.

Interventions: intervention 1: canakinumab intervention 2: dexamethasone intervention 3: placebo matching canakinumab intervention 4: placebo matching dexamethasone
Intervention descriptions: intervention 1: 10 mg/kg intravenous infusion 250 mL over 2 hours. intervention 2: 12 mg intravenous infusion 50 mL over 30 minutes. intervention 3: 5% glucose in water intravenous infusion. intervention 4: Placebo intravenous infusion.

Protocol document: