Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472992
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2007-05-11
Brief Title:
Pregnancy Exposure Registry for Tysabri
Sponsor:
Biogen
Organization:
Biogen
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 Crohns 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:
None
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?:
None