AMEVIVE� Pregnancy Registry
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: Amevive exposure (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Vice President Medical Affairs, Study Director, Affiliation: Astellas Pharma Global Development
Summary
This is an observational, exposure-registration and follow-up study, to be conducted in the
United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor
pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase
in the risk of major birth defects.
The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development
and will be managed by INC Research. The Registry will be monitored by an independent
Advisory Committee of external experts in relevant specialties of teratology, epidemiology,
maternal and fetal medicine, and infectious disease medicine (external member details
available upon request).
Clinical Details
Official title: Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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
Secondary outcome: To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®To evaluate gestational age, body weight, gender, head circumference, and body length in live born infants exposed to AMEVIVE® To evaluate appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 and 5 minutes of age in live born infants exposed to AMEVIVE® To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE® To evaluate clinically significant infections with unusual organisms, not requiring hospitalization in live born infants exposed to AMEVIVE® To evaluate malignancies in live born infants exposed to AMEVIVE®
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
INC Research, Wilmington, North Carolina 28405, United States
Additional Information
Link to Results on JAPIC
Starting date: December 2003
Last updated: December 10, 2013
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