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New study tracks birth defect risks in MS drug BRIUMVI during pregnancy

NCT ID NCT06433765

Knowledge-focused Sponsor: TG Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This registry study follows pregnant women with multiple sclerosis (MS) who have taken BRIUMVI, comparing them to those who haven't taken the drug. The goal is to see if BRIUMVI increases the risk of major birth defects. Researchers will enroll about 728 participants across two groups to gather real-world safety data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide clearer safety data on BRIUMVI use during pregnancy, helping doctors and patients make informed decisions.
What could go wrong
This is an observational registry, not a treatment trial, so it won't test new therapies. Results depend on accurate reporting and may take years to gather enough data.

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 728 people

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

Started

Jun 2024

Expected to finish

Mar 2035

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 study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.

Ages

15 to 50 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.

Inclusion Criteria: 1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®. 2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy. 3. Diagnosis of MS. 4. Currently or recently (within 1 year of pregnancy outcome) pregnant. 5. Authorization from healthcare provider to provide data to registry. Exclusion Criteria: 1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy. 2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled). 3. Exposure to known teratogens and/or investigational medications during pregnancy.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

    RECRUITING

    Wilmington, North Carolina, 28401-3331, United States

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