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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
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Angela Bosma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Mean change in EASI (Eczema Area and Severity Index) score [ Time Frame: 5 years ]
    Investigator-assessed outcome measure for disease severity at physical examination

  2. Mean change in IGA (Investigator's Global Assessment) score [ Time Frame: 5 years ]
    Investigator-assessed outcome measure for global disease severity

  3. Mean change in POEM (Patient-Oriented Eczema Measure) score [ Time Frame: 5 years ]
    Patient-reported outcome measure for symptoms of atopic eczema

  4. Mean change in PGA (Patient's Global Assessment) score [ Time Frame: 5 years ]
    Patient-reported outcome measure for global disease severity

  5. Mean change in DLQI (Dermatology Life Quality Index) score [ Time Frame: 5 years ]
    Patient-reported outcome measure for skin-related quality of life

  6. 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

  7. The occurrence of severe adverse events [ Time Frame: 5 years ]
    Any undesirable experience of severe nature occurring to a subject is reported

  8. 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
TREAT NL biobank substudy


Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Contacts
Contact: Angela L. Bosma +31205662757 a.l.bosma@amc.uva.nl
Contact: Priscella B. Eppenga +31205662481 p.b.eppenga@amc.uva.nl

Locations
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: Angela Bosma         
Contact: Priscella Eppenga         
Principal Investigator: Phyllis Spuls, prof.dr.         
Sub-Investigator: Pina Middelkamp Hup, dr.         
Sub-Investigator: Louise Gerbens, dr.         
Sub-Investigator: Angela Bosma         
Sub-Investigator: Priscella Eppenga         
Sponsors and Collaborators
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

Additional Information:
Publications:
Responsible Party: Angela Bosma, Co-investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03621137     History of Changes
Other Study ID Numbers: TREAT NL registry
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Angela Bosma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Atopic Eczema
Atopic Dermatitis
Registries
Systemic therapies
Off-label use
Phototherapy
Child
Adult

Additional relevant MeSH terms:
Eczema
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases