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MS drug safety in pregnancy under scrutiny: new study tracks birth outcomes

NCT ID NCT05688436

Knowledge-focused Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes over 1,100 pregnant women with multiple sclerosis to see if taking the drug diroximel fumarate (VUMERITY) affects their babies' health. Researchers will compare birth defects, miscarriages, preterm births, and stillbirths among women who took DRF, other MS drugs, or no MS drugs during pregnancy. No treatments are changed—only medical records are reviewed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,178 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 49 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • OptumInsight

    Eden Prairie, Minnesota, 55344-2503, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.