CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
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: 10 лет — 15 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.
Подробное описание
The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
Первичные конечные точки
- AD epidemiology, presentation, natural history, management, and outcomes [Срок оценки: Through Study completion until the subject is 18 years]
Вторичные конечные точки (12)
- Percentage of patients with history of comorbidities [Срок оценки: Time Frame: at registry enrollment]
- Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD [Срок оценки: every 6 months until the subject is 18 years]
- Physician reported: Nail changes due to atopic dermatitis (graduated VAS) [Срок оценки: every 6 months until the subject is 18 years]
- Atopic dermatitis body surface area (BSA) [Срок оценки: every 6 months until the subject is 18 years]
- Eczema Area and Severity Index (EASI) (calculated) [Срок оценки: every 6 months until the subject is 18 years]
- Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated) [Срок оценки: every 6 months until the subject is 18 years]
- Patient reported : Patient global assessments of disease control and severity [Срок оценки: every 6 months until the subject is 18 years]
- Physician reported : Pubertal Progression: Tanner Staging Assessment [Срок оценки: Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment]
- Patient reported: Patient Oriented Eczema Measure (POEM) [Срок оценки: every 6 months until the subject is 18 years]
- Patient reported: Peak pruritus (itch) NRS [Срок оценки: every 6 months until the subject is 18 years]
- Patient reported: Skin pain NRS [Срок оценки: every 6 months until the subject is 18 years]
- Patient reported: Fatigue NRS [Срок оценки: every 6 months until the subject is 18 years]
Критерии участия
Критерии включения
- To be eligible to participate in this registry, an individual must meet all the following criteria:
- Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider
- Is 10 - 15 years of age at the time of enrollment.
- Subject has initiated or is initiating an enrollment-eligible medication at the time of enrollment
Критерии исключения
- An individual who meets any of the following criteria will be excluded from participation in the registry:
- Is participating or planning to participate in a blinded clinical trial for an AD drug.
- Is unwilling or unable to provide standing height measurements.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- CorEvitas, LLC — Waltham
Идентификаторы
NCT: NCT06238765 · CorEvitas-AD-555