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 (TREAT NL)

January 30, 2024 updated by: Angela Bosma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • North-Holland
      • Amsterdam, North-Holland, Netherlands
        • Recruiting
        • Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
        • Contact:
          • Ariënna Hyseni
        • Contact:
          • Angela Bosma
        • Principal Investigator:
          • Phyllis Spuls, prof.dr.
        • Sub-Investigator:
          • Pina Middelkamp Hup, dr.
        • Sub-Investigator:
          • Louise Gerbens, dr.
        • Sub-Investigator:
          • Angela Bosma
        • Sub-Investigator:
          • Ariënna Hyseni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients of participating centres that meet the predefined in- and exclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with moderate-to-severe atopic eczema
Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema
Other: No study-specific intervention
Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in EASI (Eczema Area and Severity Index) score
Time Frame: 5 years
Investigator-assessed outcome measure for disease severity at physical examination
5 years
Mean change in IGA (Investigator's Global Assessment) score
Time Frame: 5 years
Investigator-assessed outcome measure for global disease severity
5 years
Mean change in POEM (Patient-Oriented Eczema Measure) score
Time Frame: 5 years
Patient-reported outcome measure for symptoms of atopic eczema
5 years
Mean change in PGA (Patient's Global Assessment) score
Time Frame: 5 years
Patient-reported outcome measure for global disease severity
5 years
Mean change in DLQI (Dermatology Life Quality Index) score
Time Frame: 5 years
Patient-reported outcome measure for skin-related quality of life
5 years
Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50%
Time Frame: 5 years
Investigator-assessed outcome measure for disease severity at physical examination
5 years
The occurrence of severe adverse events
Time Frame: 5 years
Any undesirable experience of severe nature occurring to a subject is reported
5 years
Drug survival of the therapies
Time Frame: 5 years
Assessment of the duration until discontinuation of a drug together with the reason thereof
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Phyllis I. Spuls, prof.dr., Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREAT NL registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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