Overview

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