BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
Overview
- Phase
- Not Applicable
- Intervention
- No intervention
- Conditions
- Multiple Sclerosis
- Sponsor
- TG Therapeutics, Inc.
- Enrollment
- 728
- Locations
- 2
- Primary Endpoint
- Percentage of Participants with Major Congenital Malformations (MCMs)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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®.
Investigators
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.
Arms & Interventions
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 \[DOC\]).
Intervention: No intervention
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.
Intervention: No intervention
Outcomes
Primary Outcomes
Percentage of Participants with Major Congenital Malformations (MCMs)
Time Frame: Up to 52 weeks post-delivery