Actively Recruiting
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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-25
50
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 years or older with no upper age limit
- Diagnosed with FMF according to Livneh criteria and confirmed by 2 specific MEFV mutations
- Persistent FMF attacks despite maximum tolerated colchicine dose (one or more attacks per month over 3 months)
- Experiencing FMF attacks defined by arthritis, chest pain, abdominal pain, myalgia, or erysipelas-like skin lesions lasting 1-4 days
- Refusal of daily anakinra injections
- Covered 100% by health insurance (ALD)
- No biological inflammation between attacks
- Provided written informed consent (patient or legal representative)
You will not qualify if you...
- Active tuberculosis or signs of latent tuberculosis
- Infection requiring intravenous antibiotics within 2 weeks prior to enrollment
- History of recurrent infections needing frequent antibiotics or multiple episodes of pneumonia or bacterial sinusitis
- Allergy or hypersensitivity to anakinra or its components
- Neutropenia (absolute neutrophil count less than 1.5 x 10^9/L)
- Unable to provide informed consent
- Receiving chronic anti IL1 biotherapy for at least 3 months
- Pregnant, in labor, or nursing
- In emergency situations or hospitalized without consent
- No health insurance coverage
- Contraindication to colchicine
- Participation in another interventional clinical trial
- Under legal protection such as guardianship, curatorship, or court protection
- Deprived of liberty
- Positive pregnancy test at screening
- Evidence of active or latent tuberculosis by chest X-ray or quantiferon test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service de Médecine interne Hopital Tenon
Paris, France, 75020
Actively Recruiting
Research Team
L
Léa SAVEY
CONTACT
S
Sophie Georgin-Lavialle, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here