Clinical trial NCT03621137: 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
Official title: TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate-to-severe Atopic Eczema
Keywords: Atopic Eczema
Atopic Dermatitis
Registries
Systemic therapies
Off-label use
Phototherapy
Child
Adult
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of participating centres that meet the predefined in- and exclusion criteria.

Brief summary: 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.


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.

Primary outcomes:
measure: Mean change in EASI (Eczema Area and Severity Index) score
timeFrame: 5 years
measure: Mean change in IGA (Investigator's Global Assessment) score
timeFrame: 5 years
measure: Mean change in POEM (Patient-Oriented Eczema Measure) score
timeFrame: 5 years
measure: Mean change in PGA (Patient's Global Assessment) score
timeFrame: 5 years
measure: Mean change in DLQI (Dermatology Life Quality Index) score
timeFrame: 5 years
measure: Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50%
timeFrame: 5 years
measure: The occurrence of severe adverse events
timeFrame: 5 years
measure: Drug survival of the therapies
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
state: North-Holland
Study officials:
affiliation: Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
name: Phyllis I. Spuls, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.