AMEVIVE® Pregnancy Registry

December 10, 2013 updated by: Astellas Pharma Inc

Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Wilmington, North Carolina, United States, 28405
        • INC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. Amevive Exposure
Pregnant women with psoriasis exposed to AMEVIVE® at any point within 8 weeks prior to conception, or at any time during pregnancy, where the outcome of the pregnancy is unknown prospectively
Observational
Other Names:
  • ASP0485
  • alefacept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®
Time Frame: At 2 months post estimated delivery date
At 2 months post estimated delivery date
To evaluate gestational age, body weight, gender, head circumference, and body length in live born infants exposed to AMEVIVE®
Time Frame: At 2 months post estimated delivery date
At 2 months post estimated delivery date
To evaluate appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 and 5 minutes of age in live born infants exposed to AMEVIVE®
Time Frame: At 2 months post estimated delivery date
At 2 months post estimated delivery date
To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE®
Time Frame: At 2 months and 12 months post estimated delivery date
At 2 months and 12 months post estimated delivery date
To evaluate clinically significant infections with unusual organisms, not requiring hospitalization in live born infants exposed to AMEVIVE®
Time Frame: At 2 months and 12 months post estimated delivery date
At 2 months and 12 months post estimated delivery date
To evaluate malignancies in live born infants exposed to AMEVIVE®
Time Frame: At 2 months and 12 months post estimated delivery date
At 2 months and 12 months post estimated delivery date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Vice President Medical Affairs, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 19, 2006

First Submitted That Met QC Criteria

June 19, 2006

First Posted (Estimate)

June 21, 2006

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 0485-CL-0002
  • C-739

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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