PPDTM CorEvitasTM Chronic Hand Eczema (CHE) 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
- В протоколе указаны: Observational (Non-Interventional) Registry.
- Кому может быть актуально
- Состояния в реестре: Chronic Hand Eczema. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The design is a prospective, observational registry for subjects with CHE under the care of dermatology or other qualified healthcare provider. Longitudinal data are collected from both subjects and their treating provider during routine clinical encounters using a structured and standardized data collection method
Подробное описание
The objective of the registry is to create a cohort of CHE subjects to evaluate long-term real world safety and effectiveness of standard of care treatments for CHE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of CHE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers.
Вмешательства
- Другое Observational (Non-Interventional) Registry
This is an observational (non-interventional) registry
Первичные конечные точки
- CHE Disease Epidemiology and presentation [Срок оценки: Every 6 months for 10 years]
- CHE Disease management, and outcomes [Срок оценки: Every 6 months for 10 years]
Критерии участия
Критерии включения
- To be eligible to participate in this registry, an individual must meet all of the following criteria:
- Diagnosed with moderate-to-severe CHE by a dermatologist or other qualified healthcare provider at the time of enrollment and initiating an eligible medication.
- Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment
- Is willing and able to consent to participation in the registry
- Is willing and able to complete registry-related forms electronically via personal devices.
- Is willing and able to provide the information (first name, last name, email address, language and primary time zone) required to create an account to allow you to complete registry forms via a personal device;
- Is willing and able to provide Personal Information (full legal name, sex, date of birth, home address zip or postal code and email address or phone number at a minimum) if required based on registry location and applicable laws and regulations.
Критерии исключения
An individual who meets any of the following criteria will be excluded from participation in the registry:
1\) Is participating or planning to participate in a blinded clinical trial for a CHE drug
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07598058 · CorEvitas-CHE-515