Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433765
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-23
Brief Title:
A Study Evaluating the Effect of BRIUMVI Ublituximab on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis MS
Sponsor:
TG Therapeutics Inc
Organization:
TG Therapeutics Inc
Study Overview
Official Title:
BRIUMVI Pregnancy Registry A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None