Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT03057860
Status:
RECRUITING
Last Update Posted:
2022-05-09
First Post:
2017-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-15', 'size': 896697, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-03T01:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2800}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2017-02-15', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of Atopic Dermatitis (oSCORAD)', 'timeFrame': 'Change from Baseline oSCORAD at 2 years', 'description': 'Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31'}], 'secondaryOutcomes': [{'measure': 'Patient Oriented Eczema Measure (POEM)', 'timeFrame': 'Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years', 'description': "Charman CR, Venn AJ, Williams HC: The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol 2004;140:1513-1519."}, {'measure': 'Severity of Pruritus and Sleeping Problems (VAS)', 'timeFrame': 'Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years', 'description': "Charman CR, Venn AJ, Williams HC: The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol 2004;140:1513-1519."}, {'measure': 'Flares (totally/well controlled weeks)', 'timeFrame': 'Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years', 'description': 'Schmitt J, Langan S, Deckert S, Svensson A, von KL, Thomas K, Spuls P: Assessment of clinical signs of atopic dermatitis: A systematic review and recommendation. J Allergy Clin Immunol 2013;10.'}, {'measure': 'Health-related Quality of Life (DLQI)', 'timeFrame': 'Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years', 'description': 'Finlay AY, Khan GK: Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19:210-216.'}, {'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': 'Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years', 'description': 'Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M: The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol 2001;10:11-18.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate-to-severe Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.treatgermany.org', 'label': 'All Information about the Register-Project'}]}, 'descriptionModule': {'briefSummary': 'About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.\n\nSome children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy.\n\nSystematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).\n\nPharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).\n\nLarge head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.\n\nIn this situation, clinical registries can provide valuable information for evidence-based clinical decision making.\n\nExtension of TREATgermany to children and adolescents is necessary as\n\n* moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood\n* it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone\n* innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria\n* adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group\n* Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care', 'detailedDescription': "Study procedures:\n\nNo study related intervention will be performed. Included patients will be prospectively followed for at least 24 months. A maximum duration of follow-up is not intended.\n\nDuring the observation period standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, physician's reasons for treatment decisions, and satisfaction with treatment.\n\nThe first study visit is scheduled at patient inclusion (baseline-visit; V1). The second and third study visits are scheduled 3 and 6 months after baseline, respectively. (V2 after 3 months, V3 after 6 months). Thereafter, study visits are scheduled after 3 months (if a new systemic treatment was initiated) or after 6 months (in case no new systemic treatment was prescribed).\n\nIn a subset of patients biosamples for molecular analyses including blood, swabs and stool will be taken at baseline and at V6, as well as skin biopsies prior to and 3 months after systemic therapy initiation. This optional module requires separate patient information and informed consent.\n\nData assessment:\n\nProspective electronic documentation of disease course and severity, medical care and pharmaceutical treatment of AD.\n\nPseudomized data will be stored at the registry center (Center for Evidence-based Healthcare, Dresden).\n\nStudy assessments include:\n\n1. A short physician report form to document patient history and clinical parameters such as the objective severity of clinical signs, affected body regions, physician's global assessment of disease severity, course of disease and medical treatment of AD including adverse events.\n2. A patient report form to assess important subjective parameters, patient reported outcomes such as symptoms, quality of life, treatment satisfaction, patient's assessment of global disease severity, totally/partial well-controlled weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate-to-severe atopic dermatitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AD according to the United Kingdom (UK) working party diagnostic criteria\n* Moderate to severe AD\n* Objective SCORAD \\> 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03057860', 'acronym': 'TREATgermany', 'briefTitle': 'TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'EK-118032016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No study intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Werfel, Prof.', 'role': 'CONTACT'}], 'facility': 'Clinics for Dermatology, Allergy and Venerology, Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Abraham, Dr.', 'role': 'CONTACT'}, {'name': 'Susanne Abraham, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan Weidinger, Prof.', 'role': 'CONTACT'}], 'facility': 'Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'centralContacts': [{'name': 'Jochen Schmitt, Prof.Dr.', 'role': 'CONTACT', 'email': 'jochen.schmitt@uniklinikum-dresden.de', 'phone': '+493514586493'}, {'name': 'Eva Haufe, Dr.', 'role': 'CONTACT', 'email': 'eva.haufe@uniklinikum-dresden.de', 'phone': '+493514586491'}], 'overallOfficials': [{'name': 'Jochen Schmitt, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Evidence-based Healthcare, Technical University Dresden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}