Multiple Sclerosis
Conditions
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®.
Interventions
OTHERNo intervention
No intervention
Sponsors
TG Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
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) (retrospectively enrolled). 3. Exposure to known teratogens and/or investigational medications during pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Major Congenital Malformations (MCMs) | Up to 52 weeks post-delivery |
Countries
United States
Contacts
CONTACTBRIUMVI® Pregnancy Registry Virtual Research Coordination Center
CONTACTTG Therapeutics Clinical Support Team
Outcome results
None listed