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Tests treatment safety and results for FMF
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
ClinicalTrials.gov ID: NCT06336733
What this study is testing
What is ANAKINRA?
ANAKINRA is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for fmf.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- 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...
- Arthritis or
- Chest pain or
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)...
- Contraindication to anakinra (Hypersensitivity to the active substance or to any of the excipients (Citric acid, anhydrous Sodium chloride, Disodium...
- Patients with neutropenia (ANC \<1.5 x 10\^9/l)
- Inability to provide informed consent
See the full eligibility 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
- 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
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 study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.