Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.

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

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Colchicine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• History of at least 1 gout flare prior to the Screening Visit

• Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.

• Presence of acute gout flare for no longer than 5 days.

• Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.

• Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.

Exclusion Criteria:

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.

• Presence of severe renal function impairment

• Contraindication to intramuscular injection

• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment

• Evidence of active pulmonary disease

• Live vaccinations within 3 months prior to the start of the study

• Use of forbidden therapy

Other protocol-defined inclusion/exclusion criteria applied