At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 182 enrolled
Drug / intervention
ACZ885 150 mg (Canakinumab)drug
Likely dose
ACZ885 150 mg (Canakinumab)from 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.
β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
In Brief
A Phase 3 clinical trial evaluating ACZ885 150 mg (Canakinumab) for Systemic Juvenile Idiopathic Arthritis (SJIA). Completed, enrolled 182 participants across 50 sites in 16 countries.
Detailed Summary
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Brazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedNov 2014
Primary CompletionOct 2016
Study CompletionSep 2017
TodayJul 2026
First PostedNov 20, 2014
Enrollment StartNov 17, 2014
Primary CompletionOct 14, 2016
Study CompletionSep 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.6 years ago
Interventions
ACZ885 150 mg (Canakinumab)drug
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.