Идёт набор NCT05721937

A Study of How Safe Abrocitinib (CIBINQO) is in Pregnant Women and Their Offspring

— 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: Abrocitinib.
Кому может быть актуально: Состояния в реестре: Atopic Dermatitis. Базовые параметры: от 0 лет · Женщины.
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

CIBINQO™ Pregnancy Registry: An Observational Study of the Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring

Обзор

The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring. The study is seeking participants who: * Are currently or recently pregnant * Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis All participants in this study will receive treatment according to routine care, as this is an observational study. The exposed group will consist of pregnant women exposed to abrocitinib during pregnancy. The unexposed group will consistent of pregnant women with moderate-to-severe atopic dermatitis who are not exposed to abrocitinib during pregnancy. The study will compare the experiences of pregnant women receiving abrocitinib to pregnant women who do not. This will help us determine if abrocitinib is safe during pregnancy. Participants will take part in this study until their infant is 12 months of age. During this time, the participant's care will be managed no differently than if she was not taking part in this study. Data will be collected through a virtual research coordinating center at enrollment, the end of the second trimester, and pregnancy outcome (live birth or fetal loss). For live-born infants, data on the infants will be collected at 4 and 12 months of age. No additional visits beyond routine care will be required.

Вмешательства

Препарат Abrocitinib
taken by mouth

Первичные конечные точки

Percent of live birth children with major congenital malformations [Срок оценки: Enrollment until 12 months after delivery]

Вторичные конечные точки (8)

Percent of participants with children with minor congenital malformations [Срок оценки: Enrollment until 12 months after delivery]
Percent of participants with spontaneous abortion [Срок оценки: Enrollment until end of pregnancy (up to 20 gestational weeks)]
Percent of participants with stillbirths [Срок оценки: Enrollment until end of pregnancy (up to 9 months)]
Percentage of participants with an elective termination [Срок оценки: Enrollment until end of pregnancy (up to 9 months)]
Percent of participants with preterm birth [Срок оценки: Enrollment until 12 months after delivery]
Percent of participants with children born small for gestational age [Срок оценки: Enrollment until 12 months after delivery]
Percentage of participants with children with postnatal growth deficiency [Срок оценки: Enrollment until 12 months after delivery]
Percent of participants with infant developmental delay [Срок оценки: Enrollment until 12 months after delivery]

Критерии участия

Критерии включения

Women of any age who are currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
Consent to participate in this study and evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Authorization for her healthcare provider(s) to provide data to the registry
Must receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy (within 1 day prior to the date of conception) OR have a diagnosis of moderate-to-severe atopic dermatitis at any time prior to pregnancy outcome.