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Идёт набор NCT07467564

The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe 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: Dupilumab.
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
Катар, Саудовская Аравия, ОАЭ
Следующий шаг
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Официальное название

The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries

Обзор

This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.

Вмешательства

  • Препарат Dupilumab
    This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Первичные конечные точки

  • Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8 [Срок оценки: Week 24]
  • Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8 [Срок оценки: Week 24]
  • Change from Baseline in HADS Total Score. [Срок оценки: Baseline to up to Week 24]
  • Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score [Срок оценки: Week 24]
  • Change from Baseline in POEM Total Score. [Срок оценки: Baseline to up to Week 24]
Вторичные конечные точки (4)
  • Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score. [Срок оценки: Baseline to week 24]
  • Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID) [Срок оценки: Week 24]
  • Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p) [Срок оценки: Baseline to up to Week 24]
  • Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p [Срок оценки: At Baseline and Week 24.]

Критерии участия

Критерии включения

  • Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.
  • Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation
  • Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.

Критерии исключения

  • Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.
  • Participants who are participating in another trial.
  • Participants with active chronic or acute infection requiring systemic treatment.
  • Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.
  • Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
  • Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

ОАЭ · 4 центра
  • Investigational Site: NMC Specialty Hospital LTD — Abu Dhabi
  • Investigational Site: Dibba Hospital — Fujairah
  • Investigational Site: Ibrahem Bin Hamad Hospital — Ras al-Khaimah
  • Investigational Site: Al Qassimi Hospital — Sharjah city
Саудовская Аравия · 2 центра
  • Investigational Site: Saudi Medical Services (Medical Fakeeh) — Jeddah
  • Investigational Site: King Faisal Specialist Hospital — Jeddah
Катар · 1 центр
  • Investigational Site: Hamad Medical Corporation — Doha

Идентификаторы

NCT: NCT07467564 · OBS18647 · U1111-1316-0051

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗