TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis (TREATgermany)

TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis

About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.

Some 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.

Systematic 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).

Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).

Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.

In this situation, clinical registries can provide valuable information for evidence-based clinical decision making.

Extension of TREATgermany to children and adolescents is necessary as

• 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
• 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
• 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
• 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
• 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

Study Overview

• Status: Recruiting
• Conditions: Moderate-to-severe Atopic Dermatitis
• Intervention / Treatment: Other: No study intervention

Detailed Description

Study procedures:

No 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.

During 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.

The 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).

In 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.

Data assessment:

Prospective electronic documentation of disease course and severity, medical care and pharmaceutical treatment of AD.

Pseudomized data will be stored at the registry center (Center for Evidence-based Healthcare, Dresden).

Study assessments include:

1. 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.
2. 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.

• Study Type: Observational
• Enrollment (Anticipated): 2800

Contacts and Locations

• Study Contact: Name: Jochen Schmitt, Prof.Dr.; Phone Number: +493514586493; Email: jochen.schmitt@uniklinikum-dresden.de
• Study Contact Backup: Name: Eva Haufe, Dr.; Phone Number: +493514586491; Email: eva.haufe@uniklinikum-dresden.de

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Recruiting
      • Clinics for Dermatology, Allergy and Venerology, Hannover Medical School
      • Contact: Thomas Werfel, Prof.
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden
      • Contact: Susanne Abraham, Dr.
      • Principal Investigator: Susanne Abraham, Dr.
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Recruiting
      • Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel
      • Contact: Stephan Weidinger, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate-to-severe atopic dermatitis

Description

Inclusion Criteria:

• AD according to the United Kingdom (UK) working party diagnostic criteria
• Moderate to severe AD
• Objective SCORAD > 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of Atopic Dermatitis (oSCORAD)	Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31	Change from Baseline oSCORAD at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Oriented Eczema Measure (POEM)	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.	Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Severity of Pruritus and Sleeping Problems (VAS)	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.	Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Flares (totally/well controlled weeks)	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.	Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Health-related Quality of Life (DLQI)	Finlay AY, Khan GK: Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19:210-216.	Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years
Eczema Area and Severity Index (EASI)	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.	Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Jochen Schmitt, Prof.Dr., Center for Evidence-based Healthcare, Technical University Dresden

Publications and helpful links

Helpful Links

• All Information about the Register-Project

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: EK-118032016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No