On-demand anakinra for painful attacks in colchicine-resistant FMF patients who refuse daily injections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized prospective trial compares on‑demand subcutaneous anakinra (100 mg daily started at prodrome and continued until 24 hours after remission, up to 7 days) plus ongoing colchicine to standard symptomatic analgesic care with ongoing colchicine in colchicine‑resistant FMF patients who decline continuous anti‑IL‑1 therapy. Eligible participants are age 6 and older with confirmed FMF (Livneh criteria and two non‑ambiguous MEFV mutations) and persistent attacks despite maximal tolerated colchicine dose. Patients with active infection, active tuberculosis, recurrent serious infections, or ongoing biological inflammation between attacks are excluded. The study is sponsored by Assistance Publique - Hôpitaux de Paris and conducted at Hopital Tenon in Paris as a randomized interventional comparison of attack‑by‑attack management strategies.

Why it matters

Who can join: the full rules

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 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

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 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's running

• Service de Médecine interne Hopital Tenon
  Paris, France Recruiting

Study contacts

• Principal investigator: Léa Léa Léa SAVEY — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Léa SAVEY
• Email: lea.savey@aphp.fr
• Phone: 0033 1 56 01 67 91

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.