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RECRUITING

NCT06336733

PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-04

Completion Date

2026-12-04

Last Updated

2025-06-25

Healthy Volunteers

Conditions

FMF

Interventions

DRUG

ANAKINRA

On demand Anakinra 100 mg/j from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) + colchicine + on demand analgesics

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

Locations (1)

Service de Médecine interne Hopital Tenon

Paris, France