At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 397 enrolled
Drug / intervention
Canakinumab 150mg in prefilled syringedrug
Likely dose
Canakinumab 150mg in prefilled syringefrom 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 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
In Brief
A Phase 3 clinical trial evaluating Canakinumab 150mg in prefilled syringe for Acute Gouty Arthritis. Completed, enrolled 397 participants across 68 sites in 4 countries.
Detailed Summary
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Gouty Arthritis
CountriesCanada, Germany, Lithuania, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedSep 2011
Primary CompletionMay 2013
TodayJul 2026
First PostedSep 9, 2011
Enrollment StartAug 25, 2011
Primary CompletionMay 9, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.8 years ago
Interventions
Canakinumab 150mg in prefilled syringedrug
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares