[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"familial-mediterranean-fever\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:familial-mediterranean-fever":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,78,107,134,153,169,193,218,247],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100632712","a-study-on-the-use-of-canakinumab-among-familial-mediterranean-fever-and-stills-disease-patients-100632712",false,"NCT07517250","A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients","Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel","Inclusion criteria:\n\n* Pediatric or adult patients who were prescribed canakinumab before October 2021 and received canakinumab for at least 6 months for the treatment of FMF or Still's disease (including SJIA or AOSD).\n* Have data on clinical characteristics and treatments available for at least 3 years following the initiation of canakinumab treatment.\n\nExclusion criteria:\n\n• Patients Aged \\\u003C2 Years (24 Months) at Index Date.","ALL","1 Year",{"count":19,"type":20},160,"ESTIMATED","OBSERVATIONAL","This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including systemic juvenile idiopathic arthritis \\[SJIA\\] and adult-onset Still's disease \\[AOSD\\]) that received canakinumab for at least 6 months.",[24,25,26,27],"Familial Mediterranean Fever","Still Disease","Systemic Juvenile Idiopathic Arthritis","Adult-Onset Still Disease",[29,30,31,32,33,34],"Canakinumab","Real-world evidence study","Treatment patterns","Clinical outcomes","Patient quality of life","Pediatric and adult patients","RECRUITING","2026-06-05",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":39},"2026-03-15",{"date":43,"type":20},"2026-12-03",{"name":45,"class":46},"Novartis Pharmaceuticals","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":59,"studyType":21,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100640752","validity-and-reliability-of-the-international-physical-fitness-questionnaire-and-the-self-perceived-health-related-physical-fitness-questionnaire-in-children-and-adolescents-with-jia-and-fmf-100640752","NCT07617558","Validity and Reliability of the International Physical Fitness Questionnaire and the Self-Perceived Health-Related Physical Fitness Questionnaire in Children and Adolescents With JIA and FMF","Investigation of the Validity and Reliability of the International Physical Fitness Questionnaire and the Self-Perceived Health-Related Physical Fitness Questionnaire for Children in Children and Adolescents Diagnosed With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever","Inclusion Criteria:\n\n* Age between 10 and 18 years\n* Diagnosis of Familial Mediterranean Fever (FMF) or Juvenile Idiopathic Arthritis (JIA) established by a pediatric rheumatologist at least six months prior\n* Voluntary willingness to participate in the study\n* Provision of informed consent by both the participant and their parents\u002Fguardians\n* Ability to ambulate independently, communicate effectively, and comply with the instructions required for the research assessments\n* Sufficient literacy to comprehend written instructions and complete study-related materials\n\nExclusion Criteria:\n\n* Having a history of a mental or psychological problem that would prevent the understanding of questions or compliance with given instructions.\n* Medically unstable conditions (history of hospitalization due to heart or lung disease or a disease flare within the 4 weeks prior to the test).\n* Having a history of a chronic disease of cardiovascular, orthopedic, neuromuscular, or neurological origin that could affect physical fitness.\n* Having a history of trauma affecting the musculoskeletal system within the last 6 months.","10 Years","18 Years",{"count":58,"type":20},100,"7 Days","Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF), two of the most prevalent pediatric rheumatologic diseases, significantly compromise the physical health of children and adolescents, leading to reduced physical fitness, muscle weakness, and a sedentary lifestyle. This study aims to evaluate the validity and reliability of the International Fitness Scale (IFS) and the Self-Perceived Health-Related Fitness Questionnaire for Children (PHFQ-C) as assessment tools for physical fitness in individuals diagnosed with JIA and FMF. Our hypothesis is that these scales will provide demonstrably reliable and valid data within this patient population. To test this, 98 patients aged 10-18 years, recruited from the Pediatric Rheumatology Clinic at Istanbul Faculty of Medicine, will participate. Their physical fitness will be objectively measured using the FitnessGram Test Battery (assessing aerobic capacity, muscular strength, and flexibility), while the IFS and PHFQ-C will be administered online. Statistical analysis, conducted using SPSS 25.0, will employ Pearson\u002FSpearman correlation for validity and Cronbach's alpha and test-retest Intraclass Correlation Coefficient (ICC) for reliability.\n\nThe expected findings will confirm the utility of the IFS and PHFQ-C as practical, economical, and valid instruments for assessing physical fitness in children and adolescents with JIA\u002FFMF. Promoting the widespread use of these scales in clinical settings will facilitate the rapid and convenient evaluation of patients' fitness levels, thereby enabling the development of early, targeted intervention strategies and ultimately contributing to an improved quality of life. Furthermore, by offering a validated alternative to standard test batteries-which are often cumbersome due to requirements for time, specialized equipment, and expert personnel-this work will make a valuable methodological contribution to the existing scientific literature.",[62,24],"Juvenile Idiopathic Arthritis",[62,24,64,65,66],"physical fitness","reliability","validity","NOT_YET_RECRUITING","2026-05-29",{"date":70,"type":39},"2026-06-01",{"date":72,"type":20},"2026-07-01",{"date":74,"type":20},"2026-10-30",{"name":76,"class":77},"Istanbul University - Cerrahpasa","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":56,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100626723","age-and-cally-index-in-familial-mediterranean-fever-100626723","NCT07439341","AGE and CALLY Index in Familial Mediterranean Fever","Association Between Skin Autofluorescence-Measured Advanced Glycation End Products and the CALLY Index in Patients With Familial Mediterranean Fever: A Cross-Sectional Controlled Study","Inclusion Criteria:\n\nFor FMF Patients:\n\n* Age between 18 and 65 years\n* Diagnosis of Familial Mediterranean Fever according to Tel-Hashomer criteria\n* At least 6 months of clinical follow-up\n* Available routine laboratory data (CRP, albumin, lymphocyte count)\n* Not in an acute FMF attack at the time of assessment\n* Ability to provide written informed consent\n\nFor Healthy Controls:\n\n* Age between 18 and 65 years\n* No history of chronic inflammatory, autoimmune, metabolic, or renal disease\n* Ability to provide written informed consent\n\nExclusion Criteria :\n\n* Diagnosis of diabetes mellitus\n* Chronic kidney disease stage 3 or higher\n* Active infection\n* Malignancy within the past 5 years\n* Dermatologic condition affecting the forearm measurement site\n* Use of high-dose antioxidant or vitamin supplementation within the past 3 months\n* Any condition that, in the opinion of the investigators, may interfere with study participation",true,"65 Years",{"count":88,"type":20},150,"Familial Mediterranean Fever (FMF) is an autoinflammatory disease characterized by recurrent inflammatory attacks and persistent low-grade inflammation. Even during attack-free periods, subclinical inflammation may continue and contribute to long-term complications.\n\nAdvanced glycation end products (AGEs) are molecules that accumulate under chronic inflammatory and oxidative stress conditions. AGEs can be measured non-invasively using skin autofluorescence (SAF). The C-reactive protein-albumin-lymphocyte (CALLY) index is a composite marker derived from routine laboratory parameters and reflects systemic inflammation and nutritional status.\n\nThis observational cross-sectional study aims to evaluate the association between skin autofluorescence-measured AGE levels and the CALLY index in patients with FMF. The study will also compare AGE levels between FMF patients and age- and sex-matched healthy controls.\n\nThe study does not involve any intervention, treatment assignment, or randomization. All laboratory parameters will be obtained from routine clinical evaluations, and AGE measurement will be performed using a non-invasive device.",[24],[92,93,94,95,96],"Advanced Glycation End Products","Skin Autofluorescence","CALLY Index","Amyloidosis","Inflammatory Biomarkers","2026-02-23",{"date":99,"type":39},"2026-02-27",{"date":101,"type":20},"2026-02-01",{"date":103,"type":20},"2026-11-01",{"name":105,"class":106},"Bursa City Hospital","OTHER_GOV",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":47},"100602961","mediterranean-diet-in-familial-mediterranean-fever-is-fatty-liver-affected-by-addition-of-aerobic-exercise-100602961","NCT07130318","Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise","Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Elliptical Aerobic Exercise","Inclusion Criteria:\n\n* familial Mediterrean fever women\n* obese women\n* women who have fatty live (non alcoholic type)\n\nExclusion Criteria:\n\n* cardiac patients\n* respiratory disease\n* renal disease\n* cancer","FEMALE","30 Years","55 Years",{"count":118,"type":20},40,"INTERVENTIONAL",[121],"NA","Familial Mediterranean fever (FMF) affect liver and causes some dysfunctions including non-alcoholic fatty liver.. still exercise and diet limitation is the treatment for this case",[24,124],"Non-Alcoholic Fatty Liver Disease","2025-08-18",{"date":127,"type":39},"2025-08-19",{"date":129,"type":39},"2025-05-08",{"date":131,"type":20},"2026-01-08",{"name":133,"class":77},"Cairo University",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":119,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":47},"100602901","outcomes-of-inspiratory-muscle-training-in-fmf-adolescents-100602901","NCT07129538","Outcomes of Inspiratory Muscle Training in FMF Adolescents","Inclusion Criteria:\n\n* FMF adolecents\n* ages 13 -17 years\n* forty patients\n\nExclusion Criteria:\n\n* cardiac problems\n* renal problems\n* liver problems\n* diabetes\n* brain problems","13 Years","17 Years",{"count":118,"type":20},[121],"Familial mediterranean fever (FMF) is common to be diagnosed before age of 18 . this disorder is connected with deterioration in exercise tolerance, pulmonary capacities, fatigue tolerance,",[24],"2025-08-12",{"date":127,"type":39},{"date":149,"type":39},"2025-05-10",{"date":151,"type":20},"2025-09-15",{"name":133,"class":77},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":114,"minAge":140,"maxAge":141,"enrollmentInfo":160,"targetDuration":4,"studyType":119,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":47},"100602960","is-there-an-effect-of-adding-body-vibration-to-intake-of-vitamin-d-on-some-outcomes-of-familial-mediterranean-fever-100602960","NCT07130305","is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever","is There an Effect of Addition of Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever","Inclusion Criteria:\n\nFMF adolecent girls ages 13 -17 years forty patients\n\nExclusion Criteria:\n\ncardiac problems renal problems liver problems diabetes brain problems",{"count":118,"type":20},[121],"Familial mediterranean fever (FMF) is common in mediterranean region. this disorder is connected with deterioration in functional performance, fitness of cardiorespiration, muscle strength, and bone mass",[24],{"date":127,"type":39},{"date":129,"type":39},{"date":167,"type":20},"2026-01-15",{"name":133,"class":77},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":17,"studyType":21,"phases":4,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":47},"100542132","can-glutenwheat-or-other-foods-be-responsible-for-fmf-attacks-100542132","NCT06338891","Can Gluten\u002FWheat or Other Foods be Responsible for FMF Attacks","Can Gluten\u002FWheat or Other Foods be Responsible for FMF Attacks: A Survey on Self-perceived Food Sensitivity in FMF Patients","Inclusion Criteria:\n\n* Patients, of both sexes, aged between 6 months and 80 years, affected by FMF, classified according to the Eurofever\u002FPRINTO criteria.\n* Patients able to understand and complete the questionnaires independently (or, in the case of pediatric ones, analyzed through the answers provided by parents).\n\nExclusion Criteria:\n\n* Patients aged \\\u003C6 months and \\>80 years.\n* Patients unable to provide informed consent or complete the questionnaires.","6 Months","80 Years",{"count":179,"type":20},60,"Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten\u002Fwheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten\u002FSensitivity, NCGS\u002FNCWS).\n\nTherefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten\u002Fwheat sensitivity in patients with FMF.",[24,182],"Non-celiac Gluten Sensitivity",[24,182],"2025-06-17",{"date":186,"type":39},"2025-06-22",{"date":188,"type":39},"2024-05-01",{"date":190,"type":20},"2026-05-01",{"name":192,"class":77},"University of Palermo",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":85,"sex":16,"minAge":56,"maxAge":116,"enrollmentInfo":201,"targetDuration":203,"studyType":21,"phases":4,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":47},"100591522","caspase-1-activity-il-1beta-and-il-18-in-patients-with-fmf-100591522","NCT06981520","Caspase-1 Activity, IL-1beta, and IL-18 in Patients With FMF","Effect of Caspase-1 Activity, IL-1beta, and IL-18 on Inflammation in the Mucosa of the Small Intestine of Patients With FMF","FMF","Inclusion Criteria:Age 18 years or older\n\nConfirmed diagnosis of Familial Mediterranean Fever (FMF) according to Tel-Hashomer clinical criteria and\u002For MEFV gene mutation analysis (for FMF group)\n\nUndergoing routine endoscopy with mucosal biopsy sampling\n\nAvailability of sufficient formalin-fixed paraffin-embedded (FFPE) tissue for immunohistochemical analysis\n\nFor controls: absence of systemic inflammatory or autoimmune disease -\n\nExclusion Criteria:History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n\nCurrent use of immunosuppressive therapy (excluding colchicine)\n\nSevere infection, active malignancy, or other systemic disease affecting intestinal mucosa\n\nInadequate biopsy specimen quality for histopathological evaluation\n\n\\-",{"count":202,"type":20},30,"8 Months","This study aims to investigate the intestinal mucosal expression of key inflammatory markers, namely Interleukin-1 (IL-1), Interleukin-18 (IL-18), and Caspase-1, in patients with Familial Mediterranean Fever (FMF). FMF is an autoinflammatory disorder characterized by recurrent episodes of fever and serosal inflammation. Recent studies suggest a possible role of intestinal immune activation in the disease pathogenesis, particularly through inflammasome-related cytokines. To better understand mucosal involvement in FMF, immunohistochemical staining for IL-1, IL-18, and Caspase-1 will be performed on intestinal biopsy samples obtained during routine endoscopic procedures. The staining intensity and distribution patterns will be evaluated and compared with age- and sex-matched healthy controls. The findings may help clarify mucosal inflammatory pathways involved in FMF and provide insight into novel therapeutic targets.",[24,206,207,208],"Intestinal Disease","Genetic Disease","Fever","2025-05-13",{"date":211,"type":39},"2025-05-20",{"date":213,"type":20},"2025-07-10",{"date":215,"type":20},"2026-01-19",{"name":217,"class":77},"Hitit University",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":177,"enrollmentInfo":225,"targetDuration":4,"studyType":119,"phases":226,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"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).",{"count":179,"type":20},[227],"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).",[24,199],[231,232,233,234,235,199,236],"RPH-104","colchicine inefficacy","colchicine intolerance","colchicine resistance","subcutaneous","interleukin-1 inhibitor","2024-12-10",{"date":239,"type":39},"2024-12-16",{"date":241,"type":39},"2021-10-05",{"date":243,"type":20},"2029-01",{"name":245,"class":46},"R-Pharm International, LLC",8,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":85,"sex":16,"minAge":254,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":246},"100399224","characterization-of-a-functional-test-for-mediterranean-family-fever-screening---2-100399224","NCT04478409","Characterization of a Functional Test for Mediterranean Family Fever Screening - 2","DEPIST-FMF 2","Inclusion Criteria:\n\n* Children 4 years of age or older or adults\n* Having a clinical picture compatible with an FMF and a previous genetic analysis finding at least one mutation of the MEFV gene pathogenic or possibly pathogenic for the FMF group;\n* Newly diagnosed or in the process of follow-up (with no time limit or evolutionary criteria);\n* During specific or non-specific treatment of the disease or without treatment;\n* For whom a blood test is planned as part of routine care;\n* Whose informed non-opposition has been collected (or parental non-opposition in the case of a minor patient);\n\nExclusion Criteria:\n\n* Person under legal protection or under the protection of justice or any other protective measures;\n* Person out of state to express their consent;\n* Person in emergency situation, vital or not;\n* Known infections with HIV and \u002F or HBV and \u002F or HCV;","4 Years",{"count":19,"type":20},"Familial Mediterranean fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 \u002F 10,000 inhabitants). It is caused by mutations in the MEFV gene, which encodes variants of the Pyrine inflammasome. Inflammasomes are protein complexes of the innate immunity that produce pro-inflammatory cytokines (interleukin-1β).\n\nIn vitro, our preliminary results demonstrated that the activation of the inflammatory pyrine (measured by the concentration of interleukin-1β) by kinase inhibitors is significantly increased in FMF patients compared to healthy subjects. Furthermore, a measurement of cell death gave significant results in differentiating the patients from the controls.\n\nThe performance of this functional has been tested, fast and simple diagnostic test on common mutations and wish to assess its characteristics for MEFV mutations.\n\nThe investigators hypothesize that this quick and simple functional test can serve as a diagnostic tool for FMF and can quantitatively discriminate against patients with different mutations (genotypes).",[24,258],"MEFV Gene Mutation",[260,261,262,263],"Familial Mediterranean fever","Interleukin-1β","MEFV gene mutation","innate immunity","2024-07-18",{"date":266,"type":39},"2024-07-19",{"date":268,"type":39},"2021-07-21",{"date":270,"type":20},"2029-07",{"name":272,"class":77},"Hospices Civils de Lyon"]