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Recruiting NCT06433765

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

— Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 15 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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®.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Percentage of Participants with Major Congenital Malformations (MCMs) [Time frame: Up to 52 weeks post-delivery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • BRIUMVI® Pregnancy Registry Virtual Research Coordination Center — Wilmington

Identifiers

NCT: NCT06433765 · TG1101-RMS403

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗