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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Moderate-to-severe Atopic Eczema

Interventions

No study-specific intervention

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Investigator-assessed outcome measure for disease severity at physical examination

Time frame: 5 years

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

Investigator-assessed outcome measure for global disease severity

Time frame: 5 years

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

Patient-reported outcome measure for symptoms of atopic eczema

Time frame: 5 years

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

Patient-reported outcome measure for global disease severity

Time frame: 5 years

Mean change in DLQI (Dermatology Life Quality Index) score

Patient-reported outcome measure for skin-related quality of life

Time frame: 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

Time frame: 5 years

The occurrence of severe adverse events

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

Time frame: 5 years

Drug survival of the therapies

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

Time frame: 5 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts