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
Assistance Publique - Hôpitaux de Paris
50 participants
Jun 4, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria13
- 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 Criteria19
- 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
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06336733