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Идёт набор NCT05658497

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

— Наблюдательное Multiple Sclerosis

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: Diroximel Fumarate, Avonex, Tysabri, Dimethyl Fumarate.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: Без ограничений · 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, Австралия, Германия, Ирландия, Испания +1
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

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Обзор

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Вмешательства

  • Препарат Diroximel Fumarate
    Administered as specified in the treatment arm.
  • Препарат Avonex
    Administered as specified in the treatment arm.
  • Биопрепарат Tysabri
    Administered as specified in the treatment arm.
  • Препарат Dimethyl Fumarate
    Administered as specified in the treatment arm.

Первичные конечные точки

  • Number of Major Congenital Malformations (MCMs) [Срок оценки: Up to 52 weeks postdelivery]
Вторичные конечные точки (12)
  • Number of Elective or Therapeutic Terminations [Срок оценки: Up to 9 months of pregnancy]
  • Number of Spontaneous Abortions [Срок оценки: Before 22 weeks of gestation]
  • Number of Fetal Deaths Including Still Birth [Срок оценки: At or after 22 weeks of gestation]
  • Number of Live Births [Срок оценки: Up to delivery (approximately 10 months)]
  • Number of Ectopic Pregnancies [Срок оценки: Up to 9 months of pregnancy]
  • Number of Molar Pregnancies [Срок оценки: Up to 9 months of pregnancy]
  • Number of Maternal Deaths [Срок оценки: Up to 12 weeks postdelivery]
  • Number of Neonatal Deaths [Срок оценки: Prior to 28 days postdelivery]
  • Number of Perinatal Deaths [Срок оценки: At or after 28 days to 12 weeks postdelivery]
  • Number of Infant Deaths [Срок оценки: Between 12 to 52 weeks postdelivery]
  • Number of Serious or Opportunistic Infections in Liveborn Children [Срок оценки: Up to 52 weeks postdelivery]
  • Number of Infants with Abnormal Postnatal Growth and Development [Срок оценки: Up to 52 weeks postdelivery]

Критерии участия

Критерии включения

  • Participant must have a diagnosis of MS
  • Documentation that the participant was one of the following:
  • exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure).
  • unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date)
  • Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth)

Критерии исключения

\- None

NOTE: Other protocol defined Inclusion criteria may apply

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 · 2 центра
  • University of Colorado Anschutz Medical Campus — Aurora
  • IQVIA US Office — Durham
Австралия · 1 центр
  • Austin Hospital — Heidelberg
Германия · 1 центр
  • Katholisches Klinikum Bochum — Bochum
Ирландия · 1 центр
  • St Vincent's University Hospital — Dublin
Испания · 1 центр
  • Hospital Universitario Ramon y Cajal — Madrid
Швейцария · 1 центр
  • Inselspital — Bern

Идентификаторы

NCT: NCT05658497 · 272MS401

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗