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