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Идёт набор NCT06259669

Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

— Наблюдательное Pregnancy Related 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: Ruxolitinib Cream.
Кому может быть актуально
Состояния в реестре: Pregnancy Related, Atopic Dermatitis. Базовые параметры: 15 лет — 50 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

A US-Prospective, Registry-Based, Observational, Exposure Cohort Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

Обзор

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

Подробное описание

This study is an exposure cohort study of women within the US with AD who were exposed to ruxolitinib cream at any time during their pregnancy period, defined as up to 24 days prior to the estimated date of conception (DOC) through the end of pregnancy, compared with women in the US with Atopic Dermatitis (AD) not exposed to ruxolitinib cream during pregnancy. The DOC is estimated to occur 14 days after the last menstrual period (LMP). Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP) by calling Syneos Health. Enrollment should occur as early in pregnancy as possible.

Вмешательства

  • Препарат Ruxolitinib Cream
    Ruxolitinib Cream

Первичные конечные точки

  • Number of major congenital malformation (MCM)s [Срок оценки: Up to 12 months after birth]
Вторичные конечные точки (12)
  • Number of minor congenital malformations [Срок оценки: Up to 12 months after birth]
  • Number of Pregnancy outcomes [Срок оценки: Up to birth]
  • Adverse pregnancy outcomes [Срок оценки: Up to birth]
  • Gestational Age [Срок оценки: At time of delivery]
  • Infant Sex [Срок оценки: At time of delivery]
  • Infant Body Weight [Срок оценки: At time of delivery]
  • Infant Body Length [Срок оценки: At time of delivery]
  • Infant Head Circumference [Срок оценки: At time of delivery]
  • APGAR Score [Срок оценки: At time of delivery]
  • Number of small for gestational age (SGA)s [Срок оценки: At time of delivery]
  • Infant Body Length [Срок оценки: Through 12 months after birth]
  • Infant Body Weight [Срок оценки: Through 12 months after birth]

Критерии участия

Критерии включения

  • Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD.
  • Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent.
  • Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome).
  • Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort.
  • Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period.
  • Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period
  • Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up.
  • Permission to contact the participant's and her infant's HCPs.

Критерии исключения

  • If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study.
  • Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Syneos Health (remote site) — Morrisville

Идентификаторы

NCT: NCT06259669 · INCB18424-MA-IAI-402

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗