Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338741
Status:
COMPLETED
Last Update Posted:
2013-08-05
First Post:
2006-06-16
Brief Title:
Rebif Pregnancy Registry
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
Rebif Pregnancy Registry
Status:
COMPLETED
Status Verified Date:
2011-08
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 objective for establishing the Rebif Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif during their pregnancies The primary end point will be the rate of spontaneous abortions in exposed pregnancies This rate will be compared with the rate of spontaneous abortions in patients with Multiple Sclerosis MS whose pregnancies were not exposed to any interferon-beta in a manner consistent with the FDA August 2002 Guidance for Industry Establishing Pregnancy Exposure Registries
Detailed Description:
This study is a post-approval commitment to follow Rebif-exposed pregnancies and compare them to non-Rebif exposed pregnancies to evaluate rate of spontaneous abortion fetal abnormality or pregnancy related health outcomes
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