About this trial
To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of
* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine. * compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment.
Eligibility criteria
Qualifiers
Age >= 6 years old with no upper limit
Proven FMF according to Livneh international criteria and 2 non ambiguous MEFV mutations.
Colchicine resistance defined as persistent FMF attack despite the maximum daily posology of colchicine (average one or more attacks per month over a 3-months period)
Arthritis or
Disqualifiers
Evidence of active tuberculosis
Infection requiring treatment with intravenous antibiotics within 2 weeks prior to inclusion
History of recurrent infection (Need more than 4 courses of antibiotic treatment per year (in children) or more >2 times per year (in adults), experience pneumonia twice over any time or >3 bacterial sinusitis in 1 year)
Contraindication to anakinra (Hypersensitivity to the active substance or to any of the excipients (Citric acid, anhydrous Sodium chloride, Disodium edetate dehydrate, Polysorbate 80, Sodium hydroxide, Water for injections ) or to E. coli derived proteins
Trial design
Treatments tested in this trial
- ANAKINRA