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

NCT03621137 | Recruiting

• 1 other identifier: TREAT NL registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate-to-severe Atopic Eczema

Keywords

Atopic Eczema; Atopic Dermatitis; Registries; Systemic therapies; Off-label use; Phototherapy; Child; Adult

Outcome Measures

Primary Outcomes (8)

• Mean change in EASI (Eczema Area and Severity Index) score

  Investigator-assessed outcome measure for disease severity at physical examination

  5 years

• Mean change in IGA (Investigator's Global Assessment) score

  Investigator-assessed outcome measure for global disease severity

  5 years

• Mean change in POEM (Patient-Oriented Eczema Measure) score

  Patient-reported outcome measure for symptoms of atopic eczema

  5 years

• Mean change in PGA (Patient's Global Assessment) score

  Patient-reported outcome measure for global disease severity

  5 years

• Mean change in DLQI (Dermatology Life Quality Index) score

  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%

  Investigator-assessed outcome measure for disease severity at physical examination

  5 years

• The occurrence of severe adverse events

  Any undesirable experience of severe nature occurring to a subject is reported

  5 years

• Drug survival of the therapies

  Assessment of the duration until discontinuation of a drug together with the reason thereof

  5 years

Study Arms (1)

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

Interventions

No study-specific intervention OTHER

Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice

Patients with moderate-to-severe atopic eczema

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

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, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 28241851 BACKGROUND

• 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.

  PMID: 28558913 BACKGROUND

• 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.

  PMID: 29761486 BACKGROUND

Related Links

• Website of the international TREAT Registry Taskforce

Biospecimen

Retention: SAMPLES WITH DNA

TREAT NL biobank substudy

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela L. Bosma

CONTACT

+31205662757; a.l.bosma@amsterdamumc.nl

Ariënna M. Hyseni

CONTACT

+31205662481; a.m.hyseni@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 8, 2018
• Study Start: November 1, 2017
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

NL (1)