Clinical Trial: Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Avonex Pregnancy Exposure Registry
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 Summary:
Sponsor: Biogen
Current Primary Outcome:
- Record and analyze birth defects and spontaneous fetal losses [ Time Frame: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy ]
- Record and analyze pregnancy outcomes [ Time Frame: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Biogen
Dates:
Date Received: September 9, 2005
Date Started: February 2004
Date Completion:
Last Updated: June 6, 2014
Last Verified: June 2014
