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
Recruiting
Phase 3
Interventional Study
FMF
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
Contacts