Actively Recruiting
Randomized Trial of On-demand Anakinra Versus Standard Analgesics in Colchicine-resistant Familial Mediterranean Fever Patients Refusing Continuous Daily Therapy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-25
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate treatments for patients with colchicine-resistant Familial Mediterranean Fever (FMF) who refuse continuous daily anti-IL-1 therapy. FMF is a genetic inflammatory disease causing recurrent painful attacks including abdominal pain, fever, and other symptoms. The study compares on-demand use of anakinra, a short-acting anti-IL-1 drug, with standard analgesics alongside daily colchicine to see which better reduces attack symptoms and duration in these patients. Participants will be randomly assigned to one of two groups: the experimental group receives on-demand anakinra injections (100 mg daily) starting from the prodromal phase of an FMF attack until 24 hours after remission, for up to 7 days, with daily colchicine and analgesics as needed. The control group receives usual analgesics combined with daily colchicine without anakinra. The study includes a 6-month treatment and follow-up period and recruits about 50 participants across multiple centers. Throughout the study, participants will be monitored at baseline, 1 month, 3 months, and 6 months. Researchers will assess the average number of FMF attacks per month as the primary outcome. Secondary outcomes include total days of attack treatment, disease activity scores, pain severity and frequency, quality of life questionnaires, injection site reactions, and adverse events. Participants will provide informed consent and undergo regular evaluations to measure treatment effects and safety over the study period.
CONDITIONS
Brief 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 international criteria and confirmed by two non-ambiguous MEFV gene mutations
- Colchicine resistance defined as having one or more FMF attacks per month over 3 months despite maximum daily colchicine dose
- FMF attacks presenting with arthritis, chest pain, abdominal pain, myalgia, or erysipelas-like skin lesions lasting 1-4 days
- Patients refusing daily anakinra injections
- Covered 100% by health insurance (ALD)
- No biological inflammation between attacks
- Written informed consent obtained from patient or legal representative
You will not qualify if you...
- Active tuberculosis or signs of latent tuberculosis
- Infection requiring intravenous antibiotics within 2 weeks before enrollment
- History of recurrent infections requiring multiple antibiotic courses or frequent pneumonia or bacterial sinusitis
- Hypersensitivity or contraindication to anakinra or its components
- Neutropenia (ANC below 1.5 x 10^9/l)
- Unable to provide informed consent
- Currently on chronic anti-IL1 therapy for at least 3 months
- Pregnant women, women in labor, or nursing mothers
- Emergency situations or hospitalized without consent
- No health insurance coverage
- Contraindication to colchicine
- Participation in another interventional clinical trial
- Under legal guardianship, curatorship, court protection, or deprived of liberty
- Positive pregnancy test at screening or latent tuberculosis on chest X-ray and quantiferon test negativity required for randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive on-demand anakinra treatment from the start of an attack until 24 hours after remission, for up to 7 days, along with daily colchicine, or they receive standard analgesics with daily colchicine.
Visits at baseline, Month 1, Month 3, and Month 6
Duration - Included within the 6-month participation period
Participants are monitored after treatment for continued assessment of FMF attacks and overall health.
Visits at Month 1, Month 3, and Month 6
Trial Site Locations
Total: 1 location
1
Service de Médecine interne Hopital Tenon
Paris, France, 75020
Actively Recruiting
Research Team
L
Léa SAVEY
S
Sophie Georgin-Lavialle, MD,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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