Clinical Trial: Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Are Given Canakinumab at
Brief Summary: This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: To evaluate, in the extension study, the safety and tolerability in gout patients. [ Time Frame: 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate the long term follow-up safety and tolerability of prophylactic treatment of canakinumab (received in the core study), observed in the core + extension study (combined) [ Time Frame: 24 weeks ]
- To assess, the efficacy of canakinumab in the treatment of recurrent acute flares of gout in the extension study in patients who were treated with canakinumab (for at least one flare) in the extension study. [ Time Frame: 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: June 23, 2009
Date Started: July 2009
Date Completion:
Last Updated: November 15, 2016
Last Verified: May 2012
