AMEVIVE® (Alefacept) Pregnancy Registry

Trial Information

AMEVIVE® (Alefacept) Pregnancy Registry

Prospective reports will be collected from pregnant subjects, health care provider (HCP), or
Astellas Product Safety Management staff. Data from the pregnant subjects will be collected
at 4 to 5 months of pregnancy by telephone interviews with the Registry. The Registry will
also contact the subject at 2 months and 12 months after the estimated delivery date (EDD)
for post-natal & pediatric follow-up. The Registry will confirm the information collected
from the subject with the HCP by telephone interviews with the Registry, 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 2 months and 12 months of age. If a birth defect is reported, targeted
follow-up will be conducted.