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)
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| ClinicalTrials.gov Identifier: NCT03621137 |
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Recruitment Status :
Recruiting
First Posted : August 8, 2018
Last Update Posted : February 16, 2022
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Moderate-to-severe Atopic Eczema | Other: No study-specific intervention |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry |
| Actual Study Start Date : | November 1, 2017 |
| Estimated Primary Completion Date : | October 31, 2027 |
| Estimated Study Completion Date : | October 31, 2027 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients with moderate-to-severe atopic eczema
Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema
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Other: No study-specific intervention
Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice |
- Mean change in EASI (Eczema Area and Severity Index) score [ Time Frame: 5 years ]Investigator-assessed outcome measure for disease severity at physical examination
- Mean change in IGA (Investigator's Global Assessment) score [ Time Frame: 5 years ]Investigator-assessed outcome measure for global disease severity
- Mean change in POEM (Patient-Oriented Eczema Measure) score [ Time Frame: 5 years ]Patient-reported outcome measure for symptoms of atopic eczema
- Mean change in PGA (Patient's Global Assessment) score [ Time Frame: 5 years ]Patient-reported outcome measure for global disease severity
- Mean change in DLQI (Dermatology Life Quality Index) score [ Time Frame: 5 years ]Patient-reported outcome measure for skin-related quality of life
- 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
- The occurrence of severe adverse events [ Time Frame: 5 years ]Any undesirable experience of severe nature occurring to a subject is reported
- Drug survival of the therapies [ Time Frame: 5 years ]Assessment of the duration until discontinuation of a drug together with the reason thereof
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621137
| Contact: Angela L. Bosma | +31205662757 | a.l.bosma@amsterdamumc.nl | |
| Contact: Ariënna M. Hyseni | +31205662481 | a.m.hyseni@amsterdamumc.nl |
| 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 | Recruiting |
| Amsterdam, North-Holland, 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 | |
| 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:
| Responsible Party: | Angela Bosma, Co-investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT03621137 |
| Other Study ID Numbers: |
TREAT NL registry |
| First Posted: | August 8, 2018 Key Record Dates |
| Last Update Posted: | February 16, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Atopic Eczema Atopic Dermatitis Registries Systemic therapies |
Off-label use Phototherapy Child Adult |
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Dermatitis, Atopic Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous |
Skin Diseases, Genetic Genetic Diseases, Inborn Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |