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).

Assistance Publique Hopitaux De Paris0 sites50 target enrollmentNovember 3, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 3, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•\- 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