Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Biogen2 个研究点分布在 1 个国家目标入组 1,178 人开始时间: 2021年9月24日最近更新: 2026年6月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Biogen
入组人数: 1,178
试验地点: 2
主要终点: Number of Major Congenital Malformations (MCMs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS.

This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are:

Those who took DRF during their pregnancy
Those who took disease-modifying therapies (DMTs) for RMS during their pregnancy, but not DRF. DMTs are drugs that slow how the disease develops over time, not just relieve symptoms.
Those who did not take any drugs for RMS during their pregnancy

The main question researchers want to learn about in this study is:

• How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth.

In this study, researchers will measure how often the following outcomes happen and compare them between groups:

Loss of pregnancy before 20 weeks
Loss of pregnancy at or after 20 weeks (stillbirth)
Babies born early (before 37 weeks)
Babies who are smaller than expected for the stage of pregnancy
Live births

This study will be done as follows:

The study includes data in adult women with multiple sclerosis on pregnancies happening between October 29th, 2019 and July 31st, 2030. Information will start being collected when the participant decides to join the study.
Medical records and clinical notes will be reviewed at the end of the study.
The study will include information from pregnancy through delivery, and for babies up to 1 year after birth.
The study is planned to end by 30th April 2031.

详细描述

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups; to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups; and to estimate the incidence of live birth and compare the incidence between the DRF and comparator groups.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 49 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Last menstrual period (LMP) between 29 October 2019 and 31 July
•Continuous medical Optum Research Database (ORD) and pharmacy (ORD and Market Clarity) coverage for a minimum of 6 months prior to and including the estimated LMP.
•Presence of MS.