[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494188":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":216,"collaborators":218,"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":228,"sex":234,"minAge":235,"maxAge":18,"enrollmentInfo":236,"targetDuration":18,"studyType":239,"phases":240,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treat-to-target","EXPERIMENTAL","T2T will be implemented based on shared decision-making (SDM), tight control and remission as a validated treatment target (disease activity score clinical SLEDAI-2k = 0 \\& glucocorticoids (GC) ≤ 5 mg prednisolone equivalent \\& physician global assessment (PGA 0-3) \\\u003C 0.5 ± immunomodulatory therapy); All intervention centers will receive T2T\u002FSDM trainings. Patients not meeting their target criterion at study entry or at any time during the trial will be included in a tight control T2T loop of 24 weeks with assessments every 6 weeks to reach the target by adjustments of their immunomodulatory treatments. Patients in target will be assessed every 12 weeks as it is standard in clinical routine care.",[13],"Other: Treat-to-target as a new treatment concept",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","In the standard of care (SoC) arm, patients receive 3-to 6-monthly controls and treatment adjustments according to their physician's discretion.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Treat-to-target as a new treatment concept","After trial initiation, the study personnel in the intervention centers will receive a training on T2T and shared decision making (SDM). Patients in the intervention centers will receive 6-weekly visits for at least 24 weeks with therapeutic adjustments to achieve remission. In case of stable remission for 6 weeks at week 24, the patients switch to 12-weekly visits until the end of the trial at week 120. In case of flare, the patient switches to 6-weekly visits for 24 consecutive weeks. Pharmaceutical treatment decisions will be guided by current treatment standards and will be taken in accordance with SDM between patients and treating physicians.",[9],[25],{"name":26,"affiliation":5,"role":27},"Matthias Schneider, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","0211 81 17817","lupus-best@rheumanet.org",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":32},"Johanna Mucke, MD","02118117817",[37,54,66,80,92,105,118,130,142,154,166,179,192,204],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Clinic Freiburg","RECRUITING","Freiburg im Breisgau","Baden-Wurttemberg","79106","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],7.85222,47.9959,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":18,"phoneExt":18,"email":18},"Stephanie Finzel, MD",{"facility":55,"status":39,"city":56,"state":41,"zip":57,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"University Clinic Heidelberg","Heidelberg","69120",{"type":46,"coordinates":59},[60,61],8.69079,49.40768,{"lat":61,"lon":60},[64],{"name":65,"role":30,"phone":18,"phoneExt":18,"email":18},"Hanns Martin Lorenz, MD",{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University Clinic Erlangen","NOT_YET_RECRUITING","Erlangen","Bavaria","91054",{"type":46,"coordinates":73},[74,75],11.00783,49.59099,{"lat":75,"lon":74},[78],{"name":79,"role":30,"phone":18,"phoneExt":18,"email":18},"Ricardo Grieshaber-Bouyer, MD",{"facility":81,"status":39,"city":82,"state":70,"zip":83,"country":43,"countryCode":44,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"LMU Munich","Munich","80336",{"type":46,"coordinates":85},[86,87],11.57549,48.13743,{"lat":87,"lon":86},[90],{"name":91,"role":30,"phone":18,"phoneExt":18,"email":18},"Hendrik Schulze-Koops, MD",{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"University Clinic Frankfurt","Frankfurt am Main","Hesse","60590",{"type":46,"coordinates":98},[99,100],8.68417,50.11552,{"lat":100,"lon":99},[103],{"name":104,"role":30,"phone":18,"phoneExt":18,"email":18},"Michaela Köhm, MD",{"facility":106,"status":39,"city":107,"state":108,"zip":109,"country":43,"countryCode":44,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Medical University Hannover","Hanover","Lower Saxony","30625",{"type":46,"coordinates":111},[112,113],9.73322,52.37052,{"lat":113,"lon":112},[116],{"name":117,"role":30,"phone":18,"phoneExt":18,"email":18},"Torsten Witte, MD",{"facility":119,"status":39,"city":120,"state":121,"zip":122,"country":43,"countryCode":44,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"University Clinic Düsseldorf","Düsseldorf","North Rhine-Westphalia","40225",{"type":46,"coordinates":124},[125,126],6.77927,51.22319,{"lat":126,"lon":125},[129],{"name":26,"role":30,"phone":18,"phoneExt":18,"email":18},{"facility":131,"status":39,"city":132,"state":121,"zip":133,"country":43,"countryCode":44,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Kliniken Essen Mitte, Essen","Essen","45136",{"type":46,"coordinates":135},[136,137],7.01228,51.45657,{"lat":137,"lon":136},[140],{"name":141,"role":30,"phone":18,"phoneExt":18,"email":18},"Gamal Chehab, MD",{"facility":143,"status":39,"city":144,"state":121,"zip":145,"country":43,"countryCode":44,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum","Herne","44649",{"type":46,"coordinates":147},[148,149],7.22572,51.5388,{"lat":149,"lon":148},[152],{"name":153,"role":30,"phone":18,"phoneExt":18,"email":18},"Ioana Andreica, MD",{"facility":155,"status":39,"city":156,"state":121,"zip":157,"country":43,"countryCode":44,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"University Clinic Münster","Münster","48149",{"type":46,"coordinates":159},[160,161],7.62571,51.96236,{"lat":161,"lon":160},[164],{"name":165,"role":30,"phone":18,"phoneExt":18,"email":18},"Martin Kriegel, MD",{"facility":167,"status":39,"city":168,"state":169,"zip":170,"country":43,"countryCode":44,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"University Clinic Mainz","Mainz","Rhineland-Palatinate","55131",{"type":46,"coordinates":172},[173,174],8.28008,49.98185,{"lat":174,"lon":173},[177],{"name":178,"role":30,"phone":18,"phoneExt":18,"email":18},"Andreas Schwarting, MD",{"facility":180,"status":39,"city":181,"state":182,"zip":183,"country":43,"countryCode":44,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"University Medical Center TU Dresden","Dresden","Saxony","01307",{"type":46,"coordinates":185},[186,187],13.73832,51.05089,{"lat":187,"lon":186},[190],{"name":191,"role":30,"phone":18,"phoneExt":18,"email":18},"Martin Aringer, MD",{"facility":193,"status":39,"city":194,"state":18,"zip":195,"country":43,"countryCode":44,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Charité - Berlin University of Medicine","Berlin","10117",{"type":46,"coordinates":197},[198,199],13.41053,52.52437,{"lat":199,"lon":198},[202],{"name":203,"role":30,"phone":18,"phoneExt":18,"email":18},"Tobias Alexander, MD",{"facility":205,"status":39,"city":206,"state":18,"zip":207,"country":43,"countryCode":44,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"UKSH Campus Kiel","Kiel","24105",{"type":46,"coordinates":209},[210,211],10.13489,54.32133,{"lat":211,"lon":210},[214],{"name":215,"role":30,"phone":18,"phoneExt":18,"email":18},"Sorwe Mojtahed Poor, MD",{"type":217,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[219,221,223],{"name":220,"class":6},"University Hospital Heidelberg",{"name":222,"class":6},"German Diabetes-Center, Leibniz-Institut in Düsseldorf",{"name":224,"class":225},"Lupus Erythematodes-Selbsthilfegemeinschaft e.V.","UNKNOWN","100494188","lupus-best---treat-to-target-in-systemic-lupus-erythematosus-100494188",false,"NCT05714930","LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus","LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus. A Multicenter Two-armed Cluster-randomized Controlled Trial","Lupus-Best","Inclusion Criteria:\n\n* Patients with SLE according to validated classification criteria\n* Age at least 18 years\n* Not in a stage of remission due to\n\n  1. Clinical SLEDAI \\> 0 AND\u002FOR\n  2. GC dosage above 5 mg prednisone equivalent per day AND\u002FOR\n  3. Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3\n* Fluent German language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Participation in other interventional trial(s)\n* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason. Examples could be:\n\n  * Life-threatening SLE manifestations that require intensive care treatment\n  * Active life-threatening diseases other than SLE\n  * Active malignancies\n  * Acute and chronic infections that do not allow the intensification of immunosuppressive treatment","ALL","18 Years",{"count":237,"type":238},606,"ESTIMATED","INTERVENTIONAL",[241],"NA","Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.",[244],"Systemic Lupus Erythematosus",[9,246],"shared decision making","2026-06-16",{"date":249,"type":250},"2026-06-17","ACTUAL",{"date":252,"type":250},"2023-12-12",{"date":254,"type":238},"2030-03-31",{"name":5,"class":6},14]