[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588161":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":48,"overallOfficials":59,"centralContacts":64,"locations":70,"responsibleParty":87,"collaborators":33,"id":89,"slug":33,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":33,"enrollmentInfo":98,"targetDuration":33,"studyType":101,"phases":33,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":73,"whyStopped":33,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"POEM","Mean POEM change","baseline to month 6",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"DLQI","Mean DLQI change","from baseline to month 6",{"measure":19,"description":20,"timeFrame":17},"RECAP","Mean RECAP change",{"measure":22,"description":23,"timeFrame":17},"EASI","Mean EASI change",{"measure":25,"description":26,"timeFrame":17},"NRS Itch (past 3 days)","Mean NRS Itch (past 3 days) change",{"measure":28,"description":29,"timeFrame":17},"NRS sleeping problems (past 3 days)","Mean NRS sleeping problems (past 3 days) change",{"measure":31,"description":32,"timeFrame":17},"EASI 75","EASI 75 change",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"CASE_CONTROL","RETROSPECTIVE","Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and negative consequences on quality of life. The goal of this study is the replication of the primary outcome (Eczema Area and Severity Index (EASI) 75 at week 16) of the Heads Up trial and the evaluation of the patient reported outcomes (Patient-oriented Eczema Measure (POEM), Dermatologic Quality of Life Index (DLQI) and Recap of Atopic Eczema (RECAP)) that were not assessed in the Heads Up trial but are part of the recommendations by the Harmonising Outcome Measures for Eczema (HOME) initiative (Williams, HC, Schmitt, J, Thomas, KS et al (2022) doi:10.1016\\\\j.jaci.2022.03.017) regarding core outcome sets in atopic dermatitis clinical trials. The core outcome set as defined by HOME encompasses the following domains (core outcome instruments): clinical signs (EASI), patient-reported symptoms (POEM and Peak Itch), long term control (RECAP) and quality of life (DLQI). The data basis is the TREATgermany registry (https:\u002F\u002Ftreatgermany.org\u002F). TREATgermany is a national clinical registry for patients with moderate to severe AD. The physician and patient-reported outcomes are collected in about 60 clinics and private practices during routine care. Data of more than 2,400 patients is currently documented.","Adult subjects with moderate to severe atopic dermatitis enrolled in the TREATgermany disease registry who are candidates for systemic therapy.",[40,44],{"label":41,"type":33,"description":33,"interventionNames":42},"Upadacitinib (treatment group)",[43],"Drug: Upadacitinib",{"label":45,"type":33,"description":33,"interventionNames":46},"Dupilumab (active comparator)",[47],"Biological: Dupilumab",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"DRUG","Upadacitinib","30 mg tablet daily",[41],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"BIOLOGICAL","Dupilumab","300 mg injection every other week",[45],[60],{"name":61,"affiliation":62,"role":63},"Jochen M Schmitt","Center for Evidence-based Healthcare, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":33,"email":69},"Thomas Birkner","CONTACT","+4935145889937","Thomas.Birkner@ukdd.de",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Center for Evidence Based Health Care","RECRUITING","Dresden","Saxony","01307","Germany","DE",{"type":80,"coordinates":81},"Point",[82,83],13.73832,51.05089,{"lat":83,"lon":82},[86],{"name":66,"role":67,"phone":68,"phoneExt":33,"email":69},{"type":88,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100588161",false,"NCT06937788","Replication of the Heads Up Atopic Dermatitis Trial With Registry Data","Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data","Re-HU-TREAT","Inclusion Criteria:\n\n* Chronic AD with onset of symptoms at least 3 years prior to baseline\n* Meets UK working party criteria\n* EASI score ≥ 16\n* ≥ 10% body surface area (BSA) of AD involvement at baseline (\"therapy start\") visit\n\nExclusion Criteria:\n\n* contraindications according to upadacitinib or dupilumab labeling","ALL","18 Years",{"count":99,"type":100},240,"ESTIMATED","OBSERVATIONAL","The goal is the replication of the primary outcome (EASI 75 at week 16) of the Heads Up trial (Blauvelt, A, Teixeira, H, Simpson, E et al (2021) doi:10.1001\u002Fjamadermatol.2021.3023) and the evaluation of the patient reported outcomes (POEM, DLQI and RECAP) in a head-to-head comparison of upadacitinib versus dupilumab treatment in moderate-to-severe atopic dermatitis (AD).",[104],"Atopic Dermatitis",[106,107,108,109],"observational","target trial emulation","dupilumab","upadacitinib","2025-08-20",{"date":112,"type":113},"2025-08-21","ACTUAL",{"date":115,"type":113},"2021-08-02",{"date":117,"type":100},"2025-12-31",{"name":5,"class":6},1]