Autoimmune Blistering Diseases Study
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: Questionnaires.
- Кому может быть актуально
- Состояния в реестре: Pemphigus Vulgaris, Pemphigus Foliaceus, Bullous Pemphigoid. 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
- США
- 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
Prevalence and Clinical Severity of Autoimmune Blistering Diseases
Обзор
Pemphigus and bullous pemphigoid (BP) are severe autoimmune blistering diseases (AIBD) that pose a critical need for new therapeutic approaches. Clinical trials in pemphigus and BP will require the availability of validated disease severity measures that can be used to define primary outcomes.
Подробное описание
The disease severity instruments for pemphigus and BP, the Pemphigus Disease Area Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI), respectively, have the potential to capture changes in all grades of disease activity, including mild disease, and therefore represent a substantial improvement over simple lesion counts or measurements of affected body surface area. However, full validation of the PDAI and BPDAI for use in clinical trials will require additional and more extensive measurements that will enable us to classify patients correctly by disease severity and be able to define the minimal change in score that is clinically significant.
This database study will compare the Pemphigus Disease Area and Severity Index (PDAI) and the Bullous Pemphigoid Disease Area Index (BPDAI) against other disease severity measures, including the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and a physician's global assessment. Additionally, patients will be asked to rate their overall disease severity using a visual analogue scale, the patient's global assessment. Participants will also have the option to donate blood samples to our AIBD blood bank for immunologic and pathophysiologic studies.
The purpose of this database study will also be to evaluate quality of life (QoL) measures and correlate these QoL measures with disease severity in patients with pemphigus and BP. QoL is an important and independent component of disease impact on patients. This database study will use the following QoL measures: the SF-36, which is a nonspecific QoL measure; the Skindez-29 and the Dermatology Life Quality Index (DLQI), which are dermatology-specific instruments; the Autoimmune Bullous Disease Quality of Life (ABQOL) and Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaires, which are AIBD-specific tools. The results will be utilized in planning future clinical studies.
The AIBD study will be conducted only at Penn at this time. Data from the study will be entered into a password protected, web-based database that is used only at Penn.
Вмешательства
- Другое Questionnaires
Первичные конечные точки
- Pemphigus Disease Area Index (PDAI) [Срок оценки: one year]
- Bullous Pemphigoid Disease Area Index (BPDAI) [Срок оценки: one year]
Вторичные конечные точки (3)
- Autoimmune Bullous Disease Quality of Life (ABQOL) [Срок оценки: one year]
- Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) [Срок оценки: one year]
- Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) [Срок оценки: one year]
Критерии участия
Критерии включения
- Gender/Age: Males or females above 18 years old
- Diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid
- Subjects able to give informed consent
Критерии исключения
- Patients who are under age 18 years.
- Patients without pemphigus or pemphigoid diseases
- Penn employees
- Penn students
- Cognitively impaired persons
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 3 центра
- Hospital of the University of Pennsylvania, Department of Dermatology — Philadelphia
- Hospital of the University of Pennsylvania — Philadelphia
- University of Pennsylvania, Department of Dermatology — Philadelphia
Идентификаторы
NCT: NCT02753777 · 824790