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

Moderate-to-severe Atopic Dermatitis Clinical Trial

— TREATgermany  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057860
• Other study ID #: EK-118032016
• Status: Recruiting
• Start date: February 1, 2016
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2022
• Source: Technische Universität Dresden
• Contact: Jochen Schmitt, Prof.Dr.
• Phone: +493514586493
• Email: jochen.schmitt[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-severe Atopic Dermatitis

Intervention

Other:
• No study intervention

Locations

Country	Name	City	State
Germany	Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden	Dresden	Saxony
Germany	Clinics for Dermatology, Allergy and Venerology, Hannover Medical School	Hannover	Lower Saxony
Germany	Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   All Information about the Register-Project