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RecruitingNCT06433765Updated Oct 29, 2026

A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

An observational study in Multiple Sclerosis, sponsored by TG Therapeutics, Inc.. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by TG Therapeutics, Inc. · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Updated Oct 29, 2026Study contact changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
728
Ages
15 Years to 50 Years
Sex
Female
01

Study summary

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

02

Conditions studied

  • Multiple Sclerosis

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03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 728 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Browse TG Therapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 medications during pregnancy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
728 participants (estimated)
Patient registry
No

Groups and cohorts

  • BRIUMVI® Exposed Cohort

    Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception \[DOC\]).

    Other: No intervention

  • BRIUMVI® Unexposed Cohort

    Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Percentage of Participants with Major Congenital Malformations (MCMs)

    Time frame: Up to 52 weeks post-delivery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Mar 2035, 129 months after the start.

Of 91 industry-sponsored observational studies under Multiple Sclerosis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 81. This study's planned 129 months is above that.

Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
May 30, 2024
StartActual
Jun 1, 2024
Primary completionEst.
Mar 31, 2035
CompletionEst.
Mar 31, 2035
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact's phone or email changed: b•••@ppd.com→C•••@thermofisher.com; •••8489→•••8489. See the current contact
Oct 29, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • BRIUMVI® Pregnancy Registry Virtual Research Coordination Center · Wilmington, United StatesContact added C•••@thermofisher.com
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Contact Study contact's phone or email changed: b•••@ppd.com→C•••@thermofisher.com; •••8489→•••8489. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • BRIUMVI® Pregnancy Registry Virtual Research Coordination Center · Wilmington, United StatesContact added C•••@thermofisher.com
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06433765
Lead sponsor
TG Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Jun 1, 2024
Primary completion
Mar 31, 2035 (estimated)
Completion
Mar 31, 2035 (estimated)
Last update
Oct 29, 2026

Study contacts

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Contact
CRGBriumviPregnancyRegistry@thermofisher.com
1-877-411-4605
TG Therapeutics Clinical Support Team
Contact
clinicalsupport@tgtxinc.com
1-877-575-8489

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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