Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - TREATswitzerland
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Atopic Dermatitis. Базовые параметры: от 12 лет · 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
- Швейцария
- 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
Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland
Обзор
As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.
Подробное описание
A prospective, non-interventional, national multicenter study in patients with moderate-to-severe AD. According to the availability of approved systemic drugs for the treatment of AD, the study will include children ≥12 years, adolescents and adult patients.
The general goal of the AD registry TREATswitzerland is to provide the scientific community with a disease-oriented prospective cohort of patients suffering from moderate-to-severe AD.
The primary objective of the AD registry is the documentation of medical care given to patients with moderate-to-severe AD in order to assess the appropriateness of care.
Further objectives of the AD registry are:
1. to evaluate the psychosocial impact of AD; 2. to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and 3. to establish a research network and foster clinical research projects.
The study procedures include:
* No study related intervention will be performed * Patients have to fulfill all inclusion criteria to be enrolled in the study. * Included patients are prospectively followed for at least 24 months. A maximum duration of follow-up is not intended. * During the observation period, standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, reasons for treatment decisions, and satisfaction with treatment.
Первичные конечные точки
- Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis [Срок оценки: 24 months]
Вторичные конечные точки (9)
- assessment of patients demographic data [Срок оценки: 24 months]
- assessment of past treatment and current treatment [Срок оценки: 24 months]
- assessment of concomitant topical therapy for AD and concomitant treatment [Срок оценки: 24 months]
- assessment of past and current comorbidities [Срок оценки: 24 months]
- change in subjective and objective SCORAD (SCORing Atopic Dermatitis) [Срок оценки: 24 months]
- change in EASI (Eczema Area and Severity Index) [Срок оценки: 24 months]
- change in DLQI (Dermatology Life Quality Index) [Срок оценки: 24 months]
- change in POEM (Patient Oriented Eczema Measure) [Срок оценки: 24 months]
- change in RECAP (Recap of atopic eczema) [Срок оценки: 24 months]
Критерии участия
Критерии включения
- Age ≥ 12 years
- AD according to the UK Working Party's Diagnostic Criteria (28)
- Moderate to severe AD as defined by
- objective SCORAD > 20 or IGA ≥ 3 (moderate) or
- currently on systemic antiinflammatory therapy for AD or
- previous systemic antiinflammatory therapy for AD within past 24 months
Критерии исключения
- refusal to sign the informed consent form
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 9 центров
- Universitätsspital Basel, Allergologie — Basel
- Inselspital, Department of Dermatology — Bern
- Dermatology & Skin Care Clinic — Buochs
- HFR Hôpital Cantonal de Fribourg — Fribourg
- Dermatologie CHUV — Lausanne
- Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie — Lucerne
- Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie — Sankt Gallen
- PLAZA Kliniken — Uster
- … и ещё 1 центр
Идентификаторы
NCT: NCT05819463 · 2022-00205