Multiple SclerosisPregnancyNewbornChildren's healthBrain and nerves
What this study is
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®.
What's being tested
- No intervention
Intervention · OTHER
No intervention
Study details
- Official title
- BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
- Sponsor
- TG Therapeutics, Inc.
- Conditions
- Multiple Sclerosis
- Enrolling
- 728 people
- Starts
- 2024-06-01
- Est. completion
- 2035-03-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 15 Years – 50 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
- Authorization from healthcare provider to provide data to registry.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
1
Study locations (1)
1 openBRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina, United States
Recruiting
Study team
Sponsor
TG Therapeutics, Inc.
Study ID TG1101-RMS403
CONTACT
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.