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Идёт набор NCT06882148

Drug Survival of Target Therapies in Atopic Dermatitis

— Наблюдательное Atopic Dermatitis

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: target therapies (biological drug, small molecules).
Кому может быть актуально
Состояния в реестре: Atopic Dermatitis. Базовые параметры: от 18 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
Италия
Следующий шаг
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Официальное название

Evaluation of Drug Survival of Target Therapies in Atopic Dermatitis

Обзор

This is an observational study with drug to evaluate the drug survival of approved target therapies in atopic dermatitis. Patients affected by moderate-severe atopic dermatitis who will start therapy with approved target drugs (dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib) for AD will be enrolled. Patients already on therapy with these drugs will also be included. During the baseline and follow up visits, clinical and demographic data will be collected, according to ordinary clinical practice. Current or retrospective disease severity scores will also be collected. Among the main: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (NRS pruritus), Sleep Numerical Rating Scale (NRS sleep), Patient Oriented Eczema Measure (POEM).

Подробное описание

Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a prevalence of 10% in adults and 20% in children. It is of primary importance to select the best treatment option as as relapses occur quickly after discontinuation.

Drug survival rate reflects efficacy, tolerability, and safety of a drug, influencing disease management and healthcare costs. AD treatment has been revolutionized by new treatments that include monoclonal antibodies (dupilumab, tralokinumab) and JAK inhibitors (abrocitinib, baricitinib, upadacitinib).

This observational study evaluates the 12-month drug survival of these approved treatments in moderate-to-severe atopic dermatitis, assessing their safety. The study also aims to evaluate the relationship between drug survival and clinical, laboratory, and pharmacological factors.

Patients affected by moderate-severe atopic dermatitis who will start therapy with approved target drugs (dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib) for AD will be enrolled. Patients already on therapy with these drugs will also be included.

During the baseline and follow up visits, clinical and demographic data will be collected, according to ordinary clinical practice. Current or retrospective disease severity scores will also be collected.

Among the main: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (NRS pruritus), Sleep Numerical Rating Scale (NRS sleep), Patient Oriented Eczema Measure (POEM).

Вмешательства

  • Препарат target therapies (biological drug, small molecules)
    describe the drug sruvival rate of the different approved drugs

Первичные конечные точки

  • drug survival evaluation [Срок оценки: 1 year]
Вторичные конечные точки (2)
  • drug survival related to safety [Срок оценки: through study completion, an average of 3 year]
  • relationship between drug survival and clinical data [Срок оценки: through study completion, an average of 3 year]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Diagnosed with moderate-to-severe atopic dermatitis (EASI>24)
  • Undergoing therapy (retrospective cohort) or undertaking systemic therapy with a biological drug or small molecules
  • (for retrospective data) presence of at least one follow-up visit after the start of treatment for which clinical and demographic data were collected at baseline and follow-up visits.
  • Signature of informed consent to the study and to the processing of personal data for the research

Критерии исключения

  • Patients under 18 years of age
  • Patients who have undergone systemic therapy with a biological drug or small molecules for whom the start date of treatment is not available and/or no clinical-demographic data were collected at baseline and at follow-up visits.
  • Absence of informed consent to the study and processing of personal data for research purposes.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • fondazione policlinico universitario agostino gemelli IRCCS — Rome

Идентификаторы

NCT: NCT06882148 · 5909

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗