[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517003":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":24,"enrollmentInfo":79,"targetDuration":24,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Etanercept","EXPERIMENTAL","treatment with etanercept in addition to NSAID treatment and\u002For classic Disease Modifying Antirheumatic Drugs",[13],"Drug: Etanercept",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","treatment with placeboin addition to NSAID treatment and\u002For classic Disease Modifying Antirheumatic Drugs",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"treatment with placebo in addition to NSAID treatment and\u002For classic Disease Modifying Antirheumatic Drugs",[15],[29],{"name":30,"affiliation":31,"role":32},"Jakub Wroński, PhD, MD","National Institute of Geriatrics, Rheumatology and Rehabilitation","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","22 6880632","+48","jakub.wronski@spartanska.pl",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Centrum Wsparcia Badań Klinicznych","RECRUITING","Warsaw","Masovian Voivodeship","02-637","Poland","PL",{"type":49,"coordinates":50},"Point",[51,52],21.01178,52.22977,{"lat":52,"lon":51},[55,59],{"name":56,"role":35,"phone":57,"phoneExt":37,"email":58},"Marta Kurek","603 315 033","marta.kurek@spartanska.pl",{"name":60,"role":35,"phone":61,"phoneExt":37,"email":62},"Agnieszka Kurowska","691 326 114","agnieszka.kurowska@spartanska.pl",{"type":64,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[66],{"name":67,"class":68},"Medical Research Agency, Poland","OTHER_GOV","100517003","phase-2-study-of-the-efficacy-and-safety-of-etanercept-treatment-in-patients-with-sapho-syndrome-100517003",false,"NCT06011889","Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome","A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome","SAPHO","Inclusion Criteria:\n\n1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.\n2. Age over 18.\n3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.\n4. Expressing informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. According to the Summary of Product Characteristics (SmPC) for Enbrel.\n2. Pregnancy, breastfeeding, inability to use effective contraception during the examination.\n3. Change in the dose of NSAIDs treatment in the last 4 weeks.\n4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.\n5. Use of biological drugs \u002F synthetic targeted drugs in the last 12 weeks.\n6. Use of corticosteroids (orally or local injections), bisphosphonates and\u002For antibiotics in the last 4 weeks.\n7. Any medical condition that the investigator judges to contraindicate etanercept treatment.","ALL","18 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE2","PHASE3","The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and\u002For classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.",[88],"SAPHO Syndrome","2026-04-07",{"date":91,"type":92},"2026-04-13","ACTUAL",{"date":94,"type":92},"2024-09-04",{"date":96,"type":81},"2028-10-18",{"name":5,"class":6},1]