[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fmf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fmf":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"FMF",[28,29,30,31],"Anakinra","Familial Mediterranean fever","Colchicine resistance","Randomized prospective study","RECRUITING","2025-06-20",{"date":35,"type":36},"2025-06-25","ACTUAL",{"date":38,"type":36},"2024-06-04",{"date":40,"type":20},"2026-12-04",{"name":42,"class":43},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100453934","phase-2-safety-and-efficacy-of-rph-104-used-to-prevent-recurrent-fever-attacks-in-adult-patients-with-colchicine-resistant-or-colchicine-intolerant-familial-mediterranean-fever-100453934","NCT05190991","Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever","An International Multicenter Open-label Clinical Study of the Safety and Efficacy of RPH-104 for Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine","Inclusion Criteria:\n\n1. The patient with Familial Mediterranean Fever (FMF) with resistance to or intolerance of colchicine, who completed the core study, during which he\u002Fshe received at least one dose of RPH-104.\n2. Voluntarily signed and dated Patient Informed Consent Form (ICF) for participation in this study.\n3. The patient's ability and desire, according to the Investigator's discretion, to follow the schedule of visits, follow the study procedures and follow the Protocol requirements, including the following:\n\n   * to visit the study site every 2 weeks for RPH-104 administration by qualified study site personnel\n\nor\n\n• to learn the subcutaneous (SC) injection technique and self-administer RPH-104 at his\u002Fher accommodation as per the study Protocol\n\nor\n\n• to agree with the qualified medical personnel visits to his\u002Fher accommodation for RPH-104 administration.\n\nExclusion Criteria:\n\n1. Any medically significant event that was observed in a patient during his\u002Fher participation in the core study, as well as any other medical conditions (including psychiatric disorders) or laboratory abnormalities, which may increase the potential risk associated with participation in the study and treatment with RPH-104, or may affect the interpretation of the study results, and which, according to the Investigator's opinion, may lead to the patient's non-compliance with the study inclusion criteria.\n2. Pregnant and\u002For lactating women or women planning pregnancy during the study or within 2 months after the last RPH-104 dose.\n3. Women of childbearing potential, i.e. all females with physiological ability to conceive except for those with final cessation of menses, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status, for example, at respective age, who do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose or Men who are sexually active and do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose.\n\n   Highly effective contraception methods include:\n   * complete abstinence: if it corresponds to the preferred and conventional lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation method) and interrupted coitus are not considered acceptable contraceptive methods;\n   * female sterilization: surgical bilateral ovariectomy (with\u002Fwithout hysterectomy) or tubal ligation at least 6 weeks before the start of the core study. In a case of ovariectomy only, the female reproductive status should be verified by further hormonal test;\n   * male sterilization (with documented absence of sperm in ejaculate post vasectomy) at least 6 months before the start of the core study. Vasectomized male partner should be the only partner of the participating female subject;\n   * combination of any two of the following methods (a+b or a+c or b+c):\n\n     1. use of oral, injectable or implanted hormonal contraceptives; in a case of oral contraceptives, the woman should constantly use the same product as was used during the core study;\n     2. installation of an intrauterine device or contraceptive system;\n     3. use of barrier contraceptives: condom or occlusive cap (diaphragm or cervical cap\u002Fcontraceptive vaginal ring) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository\n4. The need for a therapy with any of the following products from the moment of signing the ICF till the study treatment period completion:\n\n   * systemic glucocorticoids at a dose exceeding 0,2 mg\u002Fkg\u002Fday of prednisolone (or 0,16 mg\u002Fkg\u002Fday of methylprednisolone, or an equivalent dose of another glucocorticoid) orally;\n   * rilonacept, tocilizumab, rituximab, canakinumab, tumor necrosis factor alpha (TNF-a) inhibitors (TNFi) and other biological products (except for RPH-104);\n   * immunosuppressants (cyclosporine, methotrexate, leflunomide, thalidomide, azathioprine, 6-mercaptopurine, cyclophosphamide, etc.);\n   * methylprednisolone (or an equivalent) at a dose of more than 40 mg\u002Fday parenterally;\n   * intramuscular, intra-articular or peri-articular administration of glucocorticoids;\n   * anakinra;\n   * tofacitinib, baricitinib;\n   * any experimental drugs (except for RPH-104)\n5. The need to use a live (attenuated) vaccine during the study or within 3 months after the last RPH-104 dose. Live attenuated vaccines include vaccines against viruses: measles, rubella, mumps, chickenpox, rotavirus, flu (as a nasal spray), yellow fever, polio (oral polio vaccine); vaccines against tuberculosis (BCG), typhoid fever (oral typhoid vaccine) and typhus (typhus vaccine). Immunocompetent family members of the patient should not be vaccinated with the oral polio vaccine during the patient's participation in the study\n6. Positive results of tuberculosis screening performed at Visit 10 of the core study (QuantiFERON-Tuberculosis(TB)\u002FT-Spot.TB test, chest X-ray).\n7. Participation in other experimental studies (except for the core study).","18 Years","80 Years",{"count":55,"type":20},60,[57],"PHASE2","The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF) with colchicine resistance or intolerance (i.e. colchicine resistant, crFMF), who completed the core study, during which they received at least one dose of RPH-104 (i.e. study patient population).",[60,26],"Familial Mediterranean Fever",[62,63,64,65,66,26,67],"RPH-104","colchicine inefficacy","colchicine intolerance","colchicine resistance","subcutaneous","interleukin-1 inhibitor","2024-12-10",{"date":70,"type":36},"2024-12-16",{"date":72,"type":36},"2021-10-05",{"date":74,"type":20},"2029-01",{"name":76,"class":77},"R-Pharm International, LLC","INDUSTRY",8,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":44},"100461754","are-mast-cells-involved-in-autoinflammatory-diseases-100461754","NCT05292768","Are Mast Cells Involved in Autoinflammatory Diseases","INFLAMAST","Inclusion Criteria:\n\n* Patients \\>18 years old with Auto-inflammatory diseases already followed up at the CeRéMAIA (french national reference center for autoinflamamtory diseases and AA amyloidosis) of Tenon hospital and included in the JIRcohorte\n* Healthy adult controls, age- and sex-matched with MAI patients, and controls with mastocytosis, an immuno-inflammatory disease.\n* Subject affiliated to or entitled to a social security scheme\n* Collection of the patient's or healthy control's non-opposition\n\nExclusion Criteria:\n\n* Subjects unable to answer questions or express themselves\n* Subjects who do not speak French\n* Subject deprived of liberty or under legal protection.",{"count":87,"type":20},590,"OBSERVATIONAL","Autoinflammatory diseases (AID) are caused by innate immunity dysregulation. AID pathophysiology is only partly understood, especially in the case of unclassified AID. Mast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS).Our aim is to evaluate the involvement of MC in AID by assessing clinical and biological signs of MC activation and studying cutaneous and digestive biopsies.",[91,26,92,93,94,95],"Autoinflammatory Disease","TRAPS","MKD","Cryopyrin Associated Periodic Syndrome","Haploinsufficiency",[97,98,99],"Autoinflammatory disease","Mast cells","Mast cell activation syndrome","NOT_YET_RECRUITING","2022-03-22",{"date":103,"type":36},"2022-03-23",{"date":105,"type":20},"2022-03",{"date":107,"type":20},"2026-10",{"name":42,"class":43}]