About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- No intervention