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 (KIN-ATTACK-FMF).

Phase 1

Conditions: Familial Mediterranean Fever (FMF)
MedDRA version: 20.0Level: SOCClassification code: 10010331Term: Congenital familial and genetic disorders Class: 21
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-506721-11-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Age > 6 years old with no upper limit. Proven FMF according to Livneh international criteria (2) 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-month 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) -Patients who do not have biological inflammation between attacks - Written informed consent of the patients and or his legal representatives

Exclusion Criteria

- 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 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 109/l) - Contraindication to colchicine - Inability to provide informed consent - Ongoing chronic treatment with anti IL1 biotherapy since at least 3 months - Pregnant women or breast feeding - No health care insurance - Patient participating in another interventional clinical trial - Patient deprived of liberty - Patient under guardianship or curatorship