Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-02 @ 2:17 PM
Study NCT ID:
NCT00472992
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2007-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Exposure Registry for Tysabri®
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
TYSABRI® Pregnancy Exposure Registry
Status:
COMPLETED
Status Verified Date:
2014-08
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 Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.
Detailed Description:
This study was conducted in coordination with the TYSABRI® Global Observational Program in Safety (TYGRIS) observational study in the United States (US), Canada, and Rest of World (ROW).
The Coordinating Center (CC) monitored participants throughout their pregnancies and monitored the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks after the Estimated Date of Delivery (EDD) in the ROW.
The Coordinating Center (CC) monitored participants throughout their pregnancies and monitored the infants until 8 to 12 weeks of age in the US and Canada, and within 4 weeks after the Estimated Date of Delivery (EDD) in the ROW.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: