NCT06336733 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
| NCT ID | NCT06336733 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | FMF |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2026-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2024-06-04 with a primary completion date of 2026-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Léa Léa Léa SAVEY
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06336733 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying FMF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06336733 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT06336733 currently recruiting?
Yes, NCT06336733 is actively recruiting participants. Contact the research team at lea.savey@aphp.fr for enrollment information.
Where is the NCT06336733 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06336733 clinical trial?
NCT06336733 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Léa Léa Léa SAVEY at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 50 participants.