AMEVIVE® Pregnancy Registry

NCT00342862 | Terminated DMC

• 2 other identifiers: 0485-CL-0002C-739
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pregnancy

Keywords

Pregnancy; Amevive; alefacept; Registry; Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (6)

• To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®

  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®

  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®

  At 2 months post estimated delivery date

• To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE®

  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®

  At 2 months and 12 months post estimated delivery date

Study Arms (1)

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

Interventions

Amevive exposure DRUG

Observational

Also known as: alefacept, ASP0485

1. Amevive Exposure

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

INC Research

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Vice President Medical Affairs

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 1, 2003
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (1)