RECRUITING

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

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Conditions

Multiple Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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®.

Official Title

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

Quick Facts

Study Start:2024-03-26
Study Completion:2025-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06433765

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.

Ages Eligible for Study:15 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
  2. 2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
  3. 3. Diagnosis of MS.
  4. 4. Currently or recently (within 1 year of pregnancy outcome) pregnant.
  5. 5. Authorization from healthcare provider to provide data to registry.
  1. 1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
  2. 2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
  3. 3. Exposure to known teratogens and/or investigational medications during pregnancy.

Contacts and Locations

Study Contact

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
CONTACT
1-877-411-4605
briumvipregnancyregistry@ppd.com
TG Therapeutics Clinical Support Team
CONTACT
1-877-555-8489
clinicalsupport@tgtxinc.com

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-03-26
Study Completion Date2025-06-28

Study Record Updates

Study Start Date2024-03-26
Study Completion Date2025-06-28

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis