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 now · Phase 3

Conditions studied: FMF

In brief

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.

Key facts

Study ID

NCT06336733

Run by

Assistance Publique - Hôpitaux de Paris

People needed

50

Starts

2024-06-04

Expected to finish

2026-12-04

Last updated by the study team

2025-06-25

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• FMF Attack is defined by:
• Arthritis or
• Chest pain or
• Abdominal pain or
• Myalgia or
• Erysipelas-like skin lesion Duration of episodes 1-4 days.
• Patient refusing daily anakinra injections-
• Patients covered at 100% by the health insurance (ALD)
• Patient who do not have biological inflammation between attacks
• Written informed consent of the patients and or his legal representatives

You may not qualify if…

• 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
• Patients with neutropenia (ANC <1.5 x 10\^9/l)
• Inability to provide informed consent
• Ongoing chronic treatment with anti IL1 biotherapy since at least 3 months
• Pregnant women
• Women in labor and nursing mothers
• Patients in emergency situations and people hospitalized without consent
• No health care insurance
• Contraindication to colchicine
• Patient participating in another interventional clinical trial
• Patient deprived of liberty
• Patient under guardianship or curatorship
• Patient under court protection
• Randomization criteria :
• Absence of active or latent tuberculosis (no tuberculosis sign on chest X-ray and a negative quantiferon)
• Negative pregnancy test

Where it is running

• Service de Médecine interne Hopital Tenon — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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