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Идёт набор NCT03621137

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

— Наблюдательное Moderate-to-severe Atopic Eczema

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No study-specific intervention.
Кому может быть актуально
Состояния в реестре: Moderate-to-severe Atopic Eczema. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry

Обзор

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.

Вмешательства

  • Другое No study-specific intervention
    Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice

Первичные конечные точки

  • Mean change in EASI (Eczema Area and Severity Index) score [Срок оценки: 5 years]
  • Mean change in IGA (Investigator's Global Assessment) score [Срок оценки: 5 years]
  • Mean change in POEM (Patient-Oriented Eczema Measure) score [Срок оценки: 5 years]
  • Mean change in PGA (Patient's Global Assessment) score [Срок оценки: 5 years]
  • Mean change in DLQI (Dermatology Life Quality Index) score [Срок оценки: 5 years]
  • Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50% [Срок оценки: 5 years]
  • The occurrence of severe adverse events [Срок оценки: 5 years]
  • Drug survival of the therapies [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, — Amsterdam

Публикации

  • 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 PMID 28241851
  • 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):2014-20 PMID 28558913
  • 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 PMID 29761486

Идентификаторы

NCT: NCT03621137 · TREAT NL registry

Первоисточники (государственные реестры)

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