Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy

ConditionFMF
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6+
SponsorAssistance Publique - Hôpitaux de Paris

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

Treatment groups

50 Participants
are divided into 2 treatment groups