A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-50
SponsorTG Therapeutics, Inc.

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

Treatment groups

728 Participants
are divided into 2 treatment groups

Sponsors and collaborators