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

ConditionMultiple Sclerosis

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

This trial does not accept healthy volunteers

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 population

The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

No intervention
Other intervention
No intervention

Treatment groups

728 Participants

are divided into 2 treatment groups

Group A: BRIUMVI® Exposed Cohort1 intervention

Group B: BRIUMVI® Unexposed Cohort1 intervention

Trial outcomes

Primary outcomes

Percentage of Participants with Major Congenital Malformations (MCMs)

Time frame

Up to 52 weeks post-delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TG Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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