At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 177 enrolled
Drug / intervention
canakinumab +1 moredrug
Likely dose
canakinumab 4 mg/kgfrom 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 Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations
In Brief
A Phase 3 clinical trial evaluating canakinumab and placebo for Systemic Juvenile Idiopathic Arthritis With Active Flare. Completed, enrolled 177 participants across 73 sites in 19 countries.
Detailed Summary
This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Brazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United States
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartJul 2009
Primary CompletionSep 2011
TodayJul 2026
First PostedApr 29, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.2 years ago
Interventions
canakinumabdrug
Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.
placebodrug
Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.