A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies

May 29, 2026 updated by: Biogen

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55344-2503
        • OptumInsight
    • Virginia
      • Reston, Virginia, United States, 20191
        • OptumInsight_Reston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The participants included in this study will be drawn from the population of adult women with MS who become pregnant between 29 October 2019 and 31 July 2030.

Description

Key Inclusion Criteria:

  • Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
  • 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.

Key Exclusion Criteria:

- Pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-DMT
Pregnant women with MS who were not exposed to DMTs.
Diroximel Fumarate (DRF)
Pregnant women with MS who were exposed to DRF.
Drug: Diroximel Fumarate
Administered as specified in the treatment arm.
Other Names:
  • VUMERITY
  • BIIB098
Non-DRF
Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF.
Biological: Alemtuzumab
Administered as specified in the treatment arm.
Drug: Fingolimod
Administered as specified in the treatment arm.
Drug: Glatiramer acetate
Administered as specified in the treatment arm.
Biological: Interferon beta
Administered as specified in the treatment arm.
Biological: Natalizumab
Administered as specified in the treatment arm.
Other Names:
  • Tysabri
  • BG00002
Biological: Ocrelizumab
Administered as specified in the treatment arm.
Biological: Peginterferon beta-1a
Administered as specified in the treatment arm.
Drug: Siponimod
Administered as specified in the treatment arm.
Biological: Ofatumumab
Administered as specified in the treatment arm.
Drug: Ozanimod
Administered as specified in the treatment arm.
Drug: Ponesimod
Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Major Congenital Malformations (MCMs)
Time Frame: Up to 52 weeks postdelivery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Spontaneous Abortions
Time Frame: Before 20 weeks of gestation
Spontaneous abortion is defined as the loss of a fetus due to natural causes before 20th week of gestation.
Before 20 weeks of gestation
Number of Preterm Births
Time Frame: At or before the 37 weeks of gestation
Preterm birth is defined as a live birth at or before the 37th week of gestation.
At or before the 37 weeks of gestation
Number of Stillbirths
Time Frame: At or after the 20 weeks of gestation
Stillbirth is defined as the loss of pregnancy at or after the 20th week of gestation.
At or after the 20 weeks of gestation
Number of Small for Gestational Age (SGA)
Time Frame: Up to 52 weeks postdelivery
SGA is defined as birthweight below the 10th percentile for gestational age.
Up to 52 weeks postdelivery
Number of Live Births
Time Frame: Up to delivery (approximately 10 months)
Livebirth is defined as a delivered fetus with any sign of life (e.g., voluntary movement, heartbeat) regardless of gestational weeks.
Up to delivery (approximately 10 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2021

Primary Completion (Estimated)

January 17, 2031

Study Completion (Estimated)

January 17, 2031

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 272MS402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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