TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No study-specific intervention.
- Who it may be relevant to
- Registry conditions: Moderate-to-severe Atopic Eczema. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
Overview
The TREAT NL (TREatment of ATopic eczema, the Netherlands) registry is a national registry for children and adults with moderate-to-severe atopic eczema aiming to gather data on their prescribed photo- and systemic immunomodulating therapies. Atopic eczema is a common, chronic, itchy, inflammatory skin disease that can have a major impact on the quality of life of patients and their immediate surroundings. Serious atopic eczema patients are treated by means of photo- or systemic immunomodulating therapy. Of these mostly off-label applied therapies, there is insufficient evidence on the short and long term for their effectiveness, safety and cost-effectiveness. Moreover, good comparative research and real-life data are lacking. With the arrival of new expensive treatments it is crucial to get insight into these treatments in order to improve quality of care. By means of a prospective registry these data can be collected and help to obtain information for clinical practice, for answering research questions, for reducing costs and implementing the results by guidelines and decision aids.
Interventions
- Other No study-specific intervention
Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice
Primary outcome measures
- Mean change in EASI (Eczema Area and Severity Index) score [Time frame: 5 years]
- Mean change in IGA (Investigator's Global Assessment) score [Time frame: 5 years]
- Mean change in POEM (Patient-Oriented Eczema Measure) score [Time frame: 5 years]
- Mean change in PGA (Patient's Global Assessment) score [Time frame: 5 years]
- Mean change in DLQI (Dermatology Life Quality Index) score [Time frame: 5 years]
- Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50% [Time frame: 5 years]
- The occurrence of severe adverse events [Time frame: 5 years]
- Drug survival of the therapies [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria;
- Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab);
- Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
Exclusion criteria
- Patient uses only (systemic) antibiotics or antihistamines;
- Patient starts with systemic immunomodulating therapy for another indication than atopic eczema;
- Insufficient understanding of the study by the patient or parent/legal representative.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, — Amsterdam
Publications
- Gerbens LA, Boyce AE, Wall D, Barbarot S, de Booij RJ, Deleuran M, Middelkamp-Hup MA, Roberts A, Vestergaard C, Weidinger S, Apfelbacher CJ, Irvine AD, Schmitt J, Williamson PR, Spuls PI, Flohr C. TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries. Trials. 2017 PMID 28241851
- Spuls PI, Gerbens LAA, Apfelbacher CJ, Wall D, Arents BWM, Barbarot S, Roberts A, Deleuran M, Middelkamp-Hup MA, Vestergaard C, Weidinger S, Schmitt J, Irvine AD, Flohr C. The International TREatment of ATopic Eczema (TREAT) Registry Taskforce: An Initiative to Harmonize Data Collection across National Atopic Eczema Photo- and Systemic Therapy Registries. J Invest Dermatol. 2017 Sep;137(9):2014-20 PMID 28558913
- Gerbens LAA, Apfelbacher CJ, Irvine AD, Barbarot S, de Booij RJ, Boyce AE, Deleuran M, Eichenfield LF, Hof MH, Middelkamp-Hup MA, Roberts A, Schmitt J, Vestergaard C, Wall D, Weidinger S, Williamson PR, Flohr C, Spuls PI; international TREAT Registry Taskforce. TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items PMID 29761486
Identifiers
NCT: NCT03621137 · TREAT NL registry