Trials / Recruiting
RecruitingNCT06433765
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 728 (estimated)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 15 Years – 50 Years
- Healthy volunteers
- Not accepted
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®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention |
Timeline
- Start date
- 2024-06-01
- Primary completion
- 2035-03-31
- Completion
- 2035-03-31
- First posted
- 2024-05-30
- Last updated
- 2026-04-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06433765. Inclusion in this directory is not an endorsement.