Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00168714
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2005-09-09
Brief Title:
Pregnancy Exposure Registry for Avonex Interferon Beta-1a
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Avonex Pregnancy Exposure Registry
Status:
COMPLETED
Status Verified Date:
2014-06
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 objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis MS exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy
Detailed Description:
None
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