Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• score over 50 on the 0-100 VAS pain scale

• acute, confirmed gout flare for no longer than 3 days

Exclusion Criteria:

• Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months

• Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours

• Pregnant or breastfeeding women

• Major surgery with high infection risk

• History of severe allergy to food or drugs

• History or risk of tuberculosis

• Active infection

Other protocol-defined inclusion/exclusion criteria may apply