BRIUMVI® for Pregnancy Outcomes in Multiple Sclerosis

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

Recruiting Observational Study
Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
15 – 50
Sex
Female
Study type
Observational
Participants needed
728 (estimated)
Sponsor
TG Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for pregnant women with Multiple Sclerosis to compare birth outcomes between those who took BRIUMVI® and those who did not. Participants must have been pregnant recently or are currently pregnant.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with Multiple Sclerosis
  • I am currently pregnant or was pregnant within the last year
  • I have received at least 1 dose of BRIUMVI® or have not taken it during my pregnancy
  • I have permission from my healthcare provider to share my information

You may not be able to join if

  • I have taken anti-CD20 monoclonal antibodies during my pregnancy
  • I had my pregnancy outcome before my first contact with the research center
  • I have been exposed to harmful substances or investigational medications during my pregnancy

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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®.

Trial Locations
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Eligibility Criteria
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…
Contacts

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

1-877-411-4605

briumvipregnancyregistry@ppd.com

CONTACT

TG Therapeutics Clinical Support Team

1-877-555-8489

clinicalsupport@tgtxinc.com

CONTACT