At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 136 enrolled
Drug / intervention
ACZ885 +1 moredrug
Likely dose
Triamcinolone acetonide 40 mgfrom 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.
An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective
In Brief
A Phase 3 clinical trial evaluating ACZ885 and Triamcinolone acetonide 40 mg for Acute Gouty Arthritis Flares. Completed, enrolled 136 participants across 56 sites in 9 countries.
Detailed Summary
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Gouty Arthritis Flares
CountriesAustralia, Canada, Estonia, Germany, Latvia, Lithuania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionMay 2013
TodayJul 2026
First PostedNov 11, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.6 years ago
Interventions
ACZ885drug
canakinumab 150 mg s.c., given on demand upon new flares
Triamcinolone acetonide 40 mgdrug
Participants received 40 mg intramuscular (IM)