[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546092":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":141,"collaborators":143,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":149,"sex":155,"minAge":156,"maxAge":26,"enrollmentInfo":157,"targetDuration":26,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":170,"whyStopped":26,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm : conventional strategy","ACTIVE_COMPARATOR","At W0, ADA administration will be continued every 14 days. At W24, the control arm will continue to receive ADA every 14 days regardless of serum ADA concentration.",[13,14],"Diagnostic Test: Blood sample","Drug: Adalimumab Injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm 2: Interventional arm : adalimumab dose spacing strategy","EXPERIMENTAL","At W0, if the serum ADA concentration is ≥ 8 μg\u002FmL, ADA administration will be spaced every 21 days. At W24, if the ADA concentration is \\\u003C 3.3 μg\u002FmL (having a serum ADA concentration above this threshold was associated with a complete therapeutic response according to one study), administrations will be repeated every 14 days. If the ADA concentration is ≥ 3.3 and \\\u003C 8μg\u002FmL, administrations will be left every 21 days. If ADA concentration is still ≥8μg\u002FmL, ADA administrations will be spaced every 28 days.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","Blood sample","A blood sample will be taken, in addition to blood samples taken for the usual follow-up, with 4 dry tubes for the determination of ADA and anti-ADA antibodies and for bio-collection.",[16,9],null,{"type":28,"name":29,"description":29,"armGroupLabels":30,"otherNames":26},"DRUG","Adalimumab Injection",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Lucile GRANGE, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","(0)477828245","+33","lucile.grange@chu-st-etienne.fr",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Martin KILLIAN, MD","(0)477829179","martin.killian@chu-st-etienne.fr",[46,58,67,76,85,94,99,108,117,123,129],{"facility":47,"status":26,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"CH Avignon","Avignon","84000","France","FR",{"type":53,"coordinates":54},"Point",[55,56],4.80892,43.94834,{"lat":56,"lon":55},{"facility":59,"status":26,"city":60,"state":26,"zip":61,"country":50,"countryCode":51,"cosmosGeoPoint":62,"geoPoint":66,"contacts":26},"Chu Montpied","Clermont-Ferrand","63003",{"type":53,"coordinates":63},[64,65],3.08682,45.77969,{"lat":65,"lon":64},{"facility":68,"status":26,"city":69,"state":26,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":26},"CHU Grenoble Alpes","Grenoble","38700",{"type":53,"coordinates":72},[73,74],5.71479,45.17869,{"lat":74,"lon":73},{"facility":77,"status":26,"city":78,"state":26,"zip":79,"country":50,"countryCode":51,"cosmosGeoPoint":80,"geoPoint":84,"contacts":26},"CH Le Puy-en-Velay","Le Puy-en-Velay","43000",{"type":53,"coordinates":81},[82,83],3.88523,45.04366,{"lat":83,"lon":82},{"facility":86,"status":26,"city":87,"state":26,"zip":88,"country":50,"countryCode":51,"cosmosGeoPoint":89,"geoPoint":93,"contacts":26},"Hôpital de la Croix Rousse","Lyon","69317",{"type":53,"coordinates":90},[91,92],4.84789,45.74906,{"lat":92,"lon":91},{"facility":95,"status":26,"city":87,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":96,"geoPoint":98,"contacts":26},"HCL - Hôpital Edouard Herriot",{"type":53,"coordinates":97},[91,92],{"lat":92,"lon":91},{"facility":100,"status":26,"city":101,"state":26,"zip":102,"country":50,"countryCode":51,"cosmosGeoPoint":103,"geoPoint":107,"contacts":26},"CHU MONTPELLIER - Hôpital Saint-Eloi","Montpellier","34090",{"type":53,"coordinates":104},[105,106],3.87635,43.61093,{"lat":106,"lon":105},{"facility":109,"status":26,"city":110,"state":26,"zip":111,"country":50,"countryCode":51,"cosmosGeoPoint":112,"geoPoint":116,"contacts":26},"APHP - Centre hospitalier national des Quinze-Vingts","Paris","75012",{"type":53,"coordinates":113},[114,115],2.3488,48.85341,{"lat":115,"lon":114},{"facility":118,"status":26,"city":110,"state":26,"zip":119,"country":50,"countryCode":51,"cosmosGeoPoint":120,"geoPoint":122,"contacts":26},"APHP - Hôpital Pitié-Salpétrière","75013",{"type":53,"coordinates":121},[114,115],{"lat":115,"lon":114},{"facility":124,"status":26,"city":110,"state":26,"zip":125,"country":50,"countryCode":51,"cosmosGeoPoint":126,"geoPoint":128,"contacts":26},"APHP - Hôpital Cochin","75014",{"type":53,"coordinates":127},[114,115],{"lat":115,"lon":114},{"facility":130,"status":26,"city":131,"state":26,"zip":132,"country":50,"countryCode":51,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Chu de Saint-Etienne","Saint-Etienne","42055",{"type":53,"coordinates":134},[135,136],4.39,45.43389,{"lat":136,"lon":135},[139,140],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},{"type":142,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[144],{"name":145,"class":146},"Direction Générale de l'Offre de Soins","OTHER_GOV","100546092","phase-4-therapeutic-drug-monitoring-based-adalimumab-de-escalation-in-non-infectious-chronic-uveitis-100546092",false,"NCT06390436","Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis","Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis: an Open-label, Non-inferiority, Randomised Clinical Trial","SMOOTH","Inclusion Criteria:\n\n* Informed and having signed the study consent form\n* Age ≥ 18 years\n* NICU according to the Standardization of Uveitis Nomenclature (SUN) criteria\n* Complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined\n* On ADA 40mg \u002F 14 days for ≥ 24 weeks (i.e. achievement of the steady state for ADA concentrations)\n* Not having received systemic corticosteroid therapy for ≥ 12 weeks\n\nExclusion Criteria:\n\n* Inability or refusal to understand and\u002For sign the informed consent form to participate in the study.\n* Inability and\u002For refusal to carry out the follow-up examinations required for the study.\n* Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion.\n* Uveitis suspected or proven to be of infectious origin\n* Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study.","ALL","18 Years",{"count":158,"type":159},320,"ESTIMATED","INTERVENTIONAL",[162],"PHASE4","Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations \\>8 μg\u002FmL was not inferior to standard.",[165,166],"Uveitis","Chronic Disease",[168,165,169],"Adalimumab","Therapeutic drug monitoring","NOT_YET_RECRUITING","2025-06-27",{"date":173,"type":174},"2025-07-01","ACTUAL",{"date":176,"type":159},"2025-06",{"date":178,"type":159},"2029-05",{"name":5,"class":6},11]