Trial Information

Summary: AMEVIVE Pregnancy Registry – Are you a pregnant woman with chronic plaque psoriasis who is taking or has taken AMEVIVE (Alefacept)?

Biogen Idec, the maker of AMEVIVE (Alefacept), has set up a pregnancy registry to collect information on pregnancies, and the children of those pregnancies, exposed to AMEVIVE.

The AMEVIVE Pregnancy Registry will collect prospective reports from pregnant women and health care providers. Information provided to the Registry will be collected through telephone interviews with the pregnant woman at 4 to 5 months of pregnancy. The Registry will also contact an enrolled subject at 2 months and 12 months after her estimated date of delivery.

Inclusion criteria:

• Pregnant women who have been exposed to AMEVIVE within 8 weeks prior to conception or at any time during pregnancy. (Registry phone representatives will help to determine eligibility.)
• Provide sufficient information to determine that the pregnancy is prospectively registered– meaning the outcome of the pregnancy is unknown. (Registry phone representatives will help to determine eligibility.)
• Provide verbal consent to participate in the Registry.
• Verbally provide contact information for herself, her health care practitioner, and the infant’s health care practitioner (if applicable).

Exclusion criteria:

• Registry phone representatives will help to determine eligibility.

For more information visit http://www.criver.com/registries/

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Trial listings updated: June 1, 2008 at 5:45:26 AM