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AMEVIVE® (Alefacept) Pregnancy Registry


N/A
N/A
N/A
Not Enrolling
Female
Pregnancy

Thank you

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.


Inclusion Criteria:



- Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time
during pregnancy

- Provide sufficient information to determine that the pregnancy is prospectively
registered (i.e., the outcome of pregnancy must be unknown prospectively)

- Provide verbal consent to participate in the Registry, and

- Verbally provide the contact information for herself, her healthcare provider (HCP),
and the infant's HCP (if applicable)

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluate pattern or increase in major birth defects in children of women w/ psoriasis who were exposed to AMEVIVE® at any time within the 8 wks prior to conception, or at any time during pregnancy, where outcome of the pregnancy is unknown prospectively

Outcome Time Frame:

At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date

Safety Issue:

No

Principal Investigator

Vice President Medical Affairs

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Institutional Review Board

Study ID:

0485-CL-0002

NCT ID:

NCT00342862

Start Date:

March 2004

Completion Date:

March 2012

Related Keywords:

  • Pregnancy
  • Pregnancy
  • Amevive
  • alefacept
  • Registry
  • Psoriasis

Name

Location

INC ResearchWilmington, North Carolina  28405