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NCT Number: NCT06433765

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

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®.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

15 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

Wilmington, North Carolina, 28401-3331, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
  • For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
  • Diagnosis of MS.
  • Currently or recently (within 1 year of pregnancy outcome) pregnant.
  • Authorization from healthcare provider to provide data to registry.

Exclusion criteria

  • Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
  • Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
  • Exposure to known teratogens and/or investigational medications during pregnancy.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: Up to 52 weeks post-delivery

Study contacts

Contact information is provided by the study sponsor or research team.

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

CONTACT

[email protected]

1-877-411-4605

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-555-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2035
Study completion
2035
First posted
May 30, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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