Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06336733
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT06336733
Study Brief:
Protocol Section:
NCT06336733