Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,178

participants targeted

Target at P75+ for all trials

Timeline

54mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

Study Progress52%

Sep 2021Jan 2031

Study Start

First participant enrolled

September 24, 2021

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed

8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2031

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2031

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

9.3 years

First QC Date

January 9, 2023

Last Update Submit

June 3, 2026

Conditions

Multiple Sclerosis

Keywords

PregnancyRelapsing forms of Multiple Sclerosis (MS)

Outcome Measures

Primary Outcomes (1)

Number of Major Congenital Malformations (MCMs)
MCMs includes abnormalities in structural development that are medically or cosmetically significant are present at birth and persist in postnatal life unless or until repaired.
Up to 52 weeks postdelivery

Secondary Outcomes (5)

Number of Spontaneous Abortions
Before 20 weeks of gestation
Number of Preterm Births
At or before the 37 weeks of gestation
Number of Stillbirths
At or after the 20 weeks of gestation
Number of Small for Gestational Age (SGA)
Up to 52 weeks postdelivery
Number of Live Births
Up to delivery (approximately 10 months)

Study Arms (3)

Diroximel Fumarate (DRF)

Pregnant women with MS who were exposed to DRF.

Drug: Diroximel Fumarate

Non-DRF

Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF.

Biological: AlemtuzumabDrug: FingolimodDrug: Glatiramer acetateBiological: Interferon betaBiological: NatalizumabBiological: OcrelizumabBiological: OfatumumabDrug: OzanimodBiological: Peginterferon beta-1aDrug: PonesimodDrug: Siponimod