AMEVIVE® Pregnancy Registry

This study has been terminated.
(The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00342862
First received: June 19, 2006
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Pregnancy
Drug: Amevive exposure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE® [ Time Frame: At 2 months and 12 months post estimated delivery date ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate malignancies in live born infants exposed to AMEVIVE® [ Time Frame: At 2 months and 12 months post estimated delivery date ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: December 2003
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: Amevive exposure
Observational
Other Names:
  • alefacept
  • ASP0485

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342862

Locations
United States, North Carolina
INC Research
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Vice President Medical Affairs Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00342862     History of Changes
Obsolete Identifiers: NCT00168675
Other Study ID Numbers: 0485-CL-0002, C-739
Study First Received: June 19, 2006
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Pregnancy
Amevive
alefacept
Registry
Psoriasis

Additional relevant MeSH terms:
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014