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Идёт набор NCT06156683

Kesimpta Pregnancy and Infant Safety Study Using Real World Data

— 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: Multiple sclerosis disease modifying drug.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: от 18 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
Швейцария
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

Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data

Обзор

The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.

Подробное описание

Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies.

The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.

The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes.

The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility.

Вмешательства

  • Другое Multiple sclerosis disease modifying drug
    There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.

Первичные конечные точки

  • Number of major congenital malformations (MCM) among live births [Срок оценки: First year of life, up to 12 months]
Вторичные конечные точки (7)
  • Number of participants with spontaneous abortions [Срок оценки: Up to 9 months]
  • Number of participants with elective termination of pregnancy [Срок оценки: Up to 9 months]
  • Number of participants with stillbirths [Срок оценки: Up to 9 months]
  • Number of participants with preterm births [Срок оценки: Up to 9 months]
  • Number of participants with preeclampsia [Срок оценки: Up to 9 months]
  • Number of participants with eclampsia [Срок оценки: Up to 9 months]
  • Number of participants small for gestational age (SGA) [Срок оценки: Up to 9 months]

Критерии участия

Критерии включения

The following overall criteria for study inclusion are applied:

  • Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period
  • Age 18-49 years at index date
  • A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources
  • Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date

In addition, the following outcome and objective specific inclusion criteria are applied:

  • For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth
  • For analyses of spontaneous abortion, elective termination of pregnancy, stillbirth, preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least one live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy
  • For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in at least one live birth
  • For analyses of MCMs among live births, spontaneous abortions, stillbirths, and elective terminations (exploratory objective): pregnancy ending in at least one live birth, spontaneous abortion, still birth, or elective termination
  • For analyses of neonatal infection: live newborn
  • For analyses of SII: newborn alive at 29 days after birth

Критерии исключения

The following overall criteria for exclusion are applied:

  • Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
  • Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance

The following outcome specific exclusion criteria are applied:

  • For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome
  • For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies involving multiples
  • For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome specific risk period

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • Novartis Investigative Site — Basel

Идентификаторы

NCT: NCT06156683 · COMB157G2405 · EUPAS106133

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗