drugset / Trial / NCT00798369

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

NCT00798369

Phase 2 Completed 200 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-11
Primary completion
2009-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Canakinumab Monoclonal antibody 10 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 25 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 50 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 90 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 150 mg Subcutaneous
Comparator Triamcinolone Acetonide Other / unclassified 40 mg Intramuscular

Indications