Pregnancy Exposure Registry for AVONEX
This is an observational, exposure-registration and follow-up study, which will be conducted in the United States (US). The AVONEX® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses inadvertently exposed to AVONEX® and to detect any potential increase in the risk of major birth defects. It is also designed to detect any potential increase in the risk of spontaneous pregnancy loss. The AVONEX® Pregnancy Exposure Registry is sponsored by Biogen Idec Inc. and will be managed by Kendle, the Registry Data Coordinating Center (DCC). The Registry will be monitored by an independent Advisory Committee consisting of external experts in relevant specialities of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Prenatal Exposure Delayed Effects
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pregnancy Exposure Registry for AVONEX|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2004|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Prospective reports will be collected from pregnant subjects, health care providers (HCPs), or Biogen Idec Drug Safety and Risk Management (DSRM) staff. Data from pregnant subjects will be collected at 4 to 5 months of pregnancy and 8 to 12 weeks after the estimated date of delivery (EDD) by telephone interviews with the Registry. The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry, paper forms mailed/faxed to the Registry, electronic forms/queries sent to the Registry, or a combination of these methods. If a live birth is reported, the infant's HCP will be contacted for the Pediatric Follow-Up at 8 to 12 weeks age. If a birth defect is reported, targeted follow-up will be conducted.