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NCT06433765 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official title:
BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06433765
Other study ID # TG1101-RMS403
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date January 1, 2030

Study information
Verified date May 2024
Source TG Therapeutics, Inc.
Contact BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Phone 1-877-411-4605
Email briumvipregnancyregistry@ppd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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®.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 728
Est. completion date January 1, 2030
Est. primary completion date January 1, 2030
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Major Congenital Malformations (MCMs) Up to 52 weeks post-delivery
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