A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Recruiting · NCT06433765 · Observational (researchers observe without assigning treatment) · Lead sponsor: TG Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
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®.
Who can take part
Age range
15 Years to 50 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- BRIUMVI® Pregnancy Registry Virtual Research Coordination Center - Wilmington, North Carolina, United States