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Purpose

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®.

Condition

Eligibility

Eligible Ages
Between 15 Years and 50 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
BRIUMVI® Exposed Cohort Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception [DOC]).
  • Other: No intervention
    No intervention
BRIUMVI® Unexposed Cohort Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.
  • Other: No intervention
    No intervention

Recruiting Locations

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina 28401-3331

More Details

Status
Recruiting
Sponsor
TG Therapeutics, Inc.

Study Contact

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
1-877-411-4605
briumvipregnancyregistry@ppd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.