Pregnancy Exposure Registry for AVONEX
| Status: | Archived |
|---|---|
| Conditions: | Neurology, Women's Studies, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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).
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.
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