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

NCT06433765

RecruitingN/A

Sponsor: TG Therapeutics, Inc.

Conditions: Multiple Sclerosis

Interventions: No intervention

Countries: United States

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 overview

Sex: FEMALE

Age: 15 Years to 50 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Wilmington, North Carolina, United States