[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541966":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ANAKINRA on Demand","EXPERIMENTAL","On demand Anakinra 100 mg\u002Fj from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) + colchicine + on demand analgesics",[13],"Drug: ANAKINRA",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Usual analgesics + colchicine",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DRUG","ANAKINRA",[9],[25],{"name":26,"affiliation":5,"role":27},"Léa Léa Léa SAVEY","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Léa SAVEY","CONTACT","0033 1 56 01 67 91","lea.savey@aphp.fr",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Sophie Georgin-Lavialle, MD,PHD","00 33 1 56 01 74 31","sophie.georgin-lavialle@aphp.fr",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Service de Médecine interne Hopital Tenon","RECRUITING","Paris","75020","France","FR",{"type":47,"coordinates":48},"Point",[49,50],2.3488,48.85341,{"lat":50,"lon":49},[53,55],{"name":30,"role":31,"phone":54,"phoneExt":18,"email":33},"00 33 1 56 01 60 77",{"name":35,"role":31,"phone":56,"phoneExt":18,"email":37},"0 33 1 56 01 74 31",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100541966","phase-3-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-100541966",false,"NCT06336733","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","Inclusion Criteria:\n\n* Age \\>= 6 years old with no upper limit\n* Proven FMF according to Livneh international criteria and 2 non ambiguous MEFV mutations.\n* 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)\n\nFMF Attack is defined by:\n\n* Arthritis or\n* Chest pain or\n* Abdominal pain or\n* Myalgia or\n* Erysipelas-like skin lesion Duration of episodes 1-4 days.\n* Patient refusing daily anakinra injections-\n* Patients covered at 100% by the health insurance (ALD)\n* Patient who do not have biological inflammation between attacks\n* Written informed consent of the patients and or his legal representatives\n\nExclusion Criteria:\n\n* Evidence of active tuberculosis\n* Infection requiring treatment with intravenous antibiotics within 2 weeks prior to inclusion\n* 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)\n* 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\n* Patients with neutropenia (ANC \\\u003C1.5 x 10\\^9\u002Fl)\n* Inability to provide informed consent\n* Ongoing chronic treatment with anti IL1 biotherapy since at least 3 months\n* Pregnant women\n* Women in labor and nursing mothers\n* Patients in emergency situations and people hospitalized without consent\n* No health care insurance\n* Contraindication to colchicine\n* Patient participating in another interventional clinical trial\n* Patient deprived of liberty\n* Patient under guardianship or curatorship\n* Patient under court protection\n\nRandomization criteria :\n\n* Absence of active or latent tuberculosis (no tuberculosis sign on chest X-ray and a negative quantiferon)\n* Negative pregnancy test","ALL","6 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of\n\n* on demand anakinra treatment (100 mg\u002Fd from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine.\n* compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment.",[76],"FMF",[78,79,80,81],"Anakinra","Familial Mediterranean fever","Colchicine resistance","Randomized prospective study","2025-06-20",{"date":84,"type":85},"2025-06-25","ACTUAL",{"date":87,"type":85},"2024-06-04",{"date":89,"type":70},"2026-12-04",{"name":5,"class":6},1]