Moderate-to-severe Atopic Eczema Clinical Trial
— TREAT NLOfficial title:
TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | October 31, 2027 |
| Est. primary completion date | October 31, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands | Amsterdam | North-Holland |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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 Feb 27;18(1):87. doi: 10.1186/s13063-016-1765-7. — View Citation
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 for national atopic eczema photo- and systemic therapy registries. Br J Dermatol. 2019 Apr;180(4):790-801. doi: 10.1111/bjd.16714. Epub 2018 Aug 3. — View Citation
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):2014-2016. doi: 10.1016/j.jid.2017.05.014. Epub 2017 May 27. No abstract available. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in EASI (Eczema Area and Severity Index) score | Investigator-assessed outcome measure for disease severity at physical examination | 5 years | |
| Primary | Mean change in IGA (Investigator's Global Assessment) score | Investigator-assessed outcome measure for global disease severity | 5 years | |
| Primary | Mean change in POEM (Patient-Oriented Eczema Measure) score | Patient-reported outcome measure for symptoms of atopic eczema | 5 years | |
| Primary | Mean change in PGA (Patient's Global Assessment) score | Patient-reported outcome measure for global disease severity | 5 years | |
| Primary | Mean change in DLQI (Dermatology Life Quality Index) score | Patient-reported outcome measure for skin-related quality of life | 5 years | |
| Primary | Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50% | Investigator-assessed outcome measure for disease severity at physical examination | 5 years | |
| Primary | The occurrence of severe adverse events | Any undesirable experience of severe nature occurring to a subject is reported | 5 years | |
| Primary | Drug survival of the therapies | Assessment of the duration until discontinuation of a drug together with the reason thereof | 5 years |