A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
What it found
No result yet.
What was tested
Treatment tested
- No intervention
What it measured
Main measures
Percentage of Participants with Major Congenital Malformations (MCMs)
Up to 52 weeks post-delivery
Who could take part
MS (type not specified) · 15 to 50
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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®.
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History
Started
Jun 2024
Main results due
Mar 2035
Finished
Mar 2035
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