At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 341 enrolled
Drug / intervention
Canakinumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Were Given Canakinumab at the Time of Gout Flare
In Brief
A Phase 2 clinical trial evaluating Canakinumab for Gouty Arthritis. Completed, enrolled 341 participants across 45 sites in 18 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGouty Arthritis
CountriesArgentina, Belgium, Colombia, Czechia, Germany, Guatemala, Hungary, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedJun 25, 2009
Enrollment StartJun 5, 2009
Primary CompletionAug 4, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.0 years ago
Interventions
Canakinumabdrug