At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 target
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 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever
In Brief
A Phase 2 clinical trial evaluating Canakinumab for Colchicine Resistant/Intolerant Familial Mediterranean Fever. Completed, enrolled 15 participants across 5 sites.
Detailed Summary
A study designed to evaluate the role of treatment with a biological agent - Canakinumab in pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or resistant for colchicine treatment. The study hypothesis is that Canakinumab will reduce attack frequency and severity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartDec 2010
Primary CompletionFeb 2012
TodayJul 2026
First PostedJun 22, 2010
Enrollment StartDec 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.0 years ago
Interventions
Canakinumabdrug