Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01088880
- Phase
- PHASE2
- Status
- Completed
Conditions
- Familial Mediterranean Fever
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Canakinumab — DRUG
Study Details
Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.
Key Dates
- Start date
- Apr 30, 2010
- Status verified
- Apr 2012
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- 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 patients with at least 50% reduction in the attack frequency during 3 month treatment period. [ Time Frame: 12 weeks ]