BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
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®.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 50
Healthy Volunteers: f
View:
• 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.
Locations
United States
North Carolina
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
RECRUITING
Wilmington
Contact Information
Primary
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
briumvipregnancyregistry@ppd.com
1-877-411-4605
Backup
TG Therapeutics Clinical Support Team
clinicalsupport@tgtxinc.com
1-877-555-8489
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2035-03-31
Participants
Target number of participants: 728
Treatments
BRIUMVI® Exposed Cohort
Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception \[DOC\]).
BRIUMVI® Unexposed Cohort
Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.
Related Therapeutic Areas
Sponsors
Leads: TG Therapeutics, Inc.