[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546092":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":140,"collaborators":142,"id":146,"slug":26,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":26,"enrollmentInfo":155,"targetDuration":26,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":168,"whyStopped":26,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"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",[46,57,66,75,84,93,98,107,116,122,128],{"facility":47,"status":26,"city":48,"state":26,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"CH Avignon","Avignon","84000","France",{"type":52,"coordinates":53},"Point",[54,55],4.80892,43.94834,{"lat":55,"lon":54},{"facility":58,"status":26,"city":59,"state":26,"zip":60,"country":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":26},"Chu Montpied","Clermont-Ferrand","63003",{"type":52,"coordinates":62},[63,64],3.08682,45.77969,{"lat":64,"lon":63},{"facility":67,"status":26,"city":68,"state":26,"zip":69,"country":50,"cosmosGeoPoint":70,"geoPoint":74,"contacts":26},"CHU Grenoble Alpes","Grenoble","38700",{"type":52,"coordinates":71},[72,73],5.71479,45.17869,{"lat":73,"lon":72},{"facility":76,"status":26,"city":77,"state":26,"zip":78,"country":50,"cosmosGeoPoint":79,"geoPoint":83,"contacts":26},"CH Le Puy-en-Velay","Le Puy-en-Velay","43000",{"type":52,"coordinates":80},[81,82],3.88523,45.04366,{"lat":82,"lon":81},{"facility":85,"status":26,"city":86,"state":26,"zip":87,"country":50,"cosmosGeoPoint":88,"geoPoint":92,"contacts":26},"Hôpital de la Croix Rousse","Lyon","69317",{"type":52,"coordinates":89},[90,91],4.84789,45.74906,{"lat":91,"lon":90},{"facility":94,"status":26,"city":86,"state":26,"zip":26,"country":50,"cosmosGeoPoint":95,"geoPoint":97,"contacts":26},"HCL - Hôpital Edouard Herriot",{"type":52,"coordinates":96},[90,91],{"lat":91,"lon":90},{"facility":99,"status":26,"city":100,"state":26,"zip":101,"country":50,"cosmosGeoPoint":102,"geoPoint":106,"contacts":26},"CHU MONTPELLIER - Hôpital Saint-Eloi","Montpellier","34090",{"type":52,"coordinates":103},[104,105],3.87635,43.61093,{"lat":105,"lon":104},{"facility":108,"status":26,"city":109,"state":26,"zip":110,"country":50,"cosmosGeoPoint":111,"geoPoint":115,"contacts":26},"APHP - Centre hospitalier national des Quinze-Vingts","Paris","75012",{"type":52,"coordinates":112},[113,114],2.3488,48.85341,{"lat":114,"lon":113},{"facility":117,"status":26,"city":109,"state":26,"zip":118,"country":50,"cosmosGeoPoint":119,"geoPoint":121,"contacts":26},"APHP - Hôpital Pitié-Salpétrière","75013",{"type":52,"coordinates":120},[113,114],{"lat":114,"lon":113},{"facility":123,"status":26,"city":109,"state":26,"zip":124,"country":50,"cosmosGeoPoint":125,"geoPoint":127,"contacts":26},"APHP - Hôpital Cochin","75014",{"type":52,"coordinates":126},[113,114],{"lat":114,"lon":113},{"facility":129,"status":26,"city":130,"state":26,"zip":131,"country":50,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Chu de Saint-Etienne","Saint-Etienne","42055",{"type":52,"coordinates":133},[134,135],4.39,45.43389,{"lat":135,"lon":134},[138,139],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},{"type":141,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[143],{"name":144,"class":145},"Direction Générale de l'Offre de Soins","OTHER_GOV","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":156,"type":157},320,"ESTIMATED","INTERVENTIONAL",[160],"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.",[163,164],"Uveitis","Chronic Disease",[166,163,167],"Adalimumab","Therapeutic drug monitoring","NOT_YET_RECRUITING","2025-06-27",{"date":171,"type":172},"2025-07-01","ACTUAL",{"date":174,"type":157},"2025-06",{"date":176,"type":157},"2029-05",{"name":5,"class":6},11]