BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
TG Therapeutics, Inc.
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
- Age range
- 15–50 years
- Sex
- Female
- Healthy volunteers
- No
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 from healthcare provider to provide data to registry. Exclusion Criteria: 1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy. 2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC…
Interventions
- OtherNo intervention
No intervention
Location
- BRIUMVI® Pregnancy Registry Virtual Research Coordination CenterWilmington, North Carolina