Clinical Trial: Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Brief Summary: Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess the effect of canakinumab with regard to percentage of patients with no attacks in month 3. [ Time Frame: 12 weeks ]
- To find the optimal dose of canakinumab for FMF in this population [ Time Frame: 12 weeks ]
- To assess changes in the severity (acute phase response and VAS evaluation of attack severity by patient) and duration of acute attacks during the treatment period [ Time Frame: 12 weeks ]
- To assess PK/PD properties of canakinumab by measuring canakinumab and IL-1beta levels before dosing
- To evaluate the safety and tolerability of canakinumab by monitoring adverse events and patient discontinuations due to AE
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: March 16, 2010
Date Started: April 2010
Date Completion:
Last Updated: April 27, 2012
Last Verified: April 2012
