Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01148797
- Phase
- PHASE2
- Status
- Completed
Conditions
- Colchicine Resistant/Intolerant Familial Mediterranean Fever
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - 20 Years
- Healthy Volunteers
- Not accepted
Interventions
- Canakinumab — DRUG
Study Details
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.
Key Dates
- Start date
- Dec 31, 2010
- Status verified
- Nov 2016
- Primary completion
- Feb 29, 2012
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Canakinumab
Primary Outcome Measure
To measure the effect of canakinumab on the frequency of FMF attacks, defined as percentage of subjects with at least 50% reduction in the attack frequency during a 3 month treatment period [ Time Frame: 0-3 months ]