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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 (KIN-ATTACK-FMF).
EU CTIS ID: 2023-506721-11-00
What this study is testing
to evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine who refuse continuous daily therapy of on demand anakinra treatment associated with daily colchicine and on demand antalgics compared to standard of care treatment with on demand antalgics associated with daily colchicine. On demand anakinra defined by: injection of 100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) or 100 mg/d to prevent an attack in the event of a known trigger factor.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 6 years old with no upper limit. Proven FMF according to Livneh international criteria (2) 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-month 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) -Patients who do not have biological inflammation between attacks - Written informed consent of the patients and or his legal representatives
You likely can't join if
- - 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 109/l) - Contraindication to colchicine - Inability to provide informed consent - Ongoing chronic treatment with anti IL1 biotherapy since at least 3 months - Pregnant women or breast feeding - No health care insurance - Patient participating in another interventional clinical trial - Patient deprived of liberty - Patient under guardianship or curatorship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.