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

Description

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®.

Conditions

Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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®.

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

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

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Wilmington

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

15 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

TG Therapeutics, Inc.,

Study Record Dates

2025-06-28