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

May 11, 2026 updated by: TG Therapeutics, Inc.

BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®

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®.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

728

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401-3331
        • Recruiting
        • BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

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

  • Child
  • Adult

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®.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Major Congenital Malformations (MCMs)
Time Frame: Up to 52 weeks post-delivery
Up to 52 weeks post-delivery

Collaborators and Investigators

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

Sponsor

TG Therapeutics, Inc.

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)

June 1, 2024

Primary Completion (Estimated)

March 31, 2035

Study Completion (Estimated)

March 31, 2035

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1101-RMS403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Multiple Sclerosis

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe