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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

June 19, 2006
December 10, 2013
December 2003
December 2011   (final data collection date for primary 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 [ Time Frame: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00342862 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
AMEVIVE® Pregnancy Registry
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Pregnancy
Drug: Amevive exposure
Observational
Other Names:
  • alefacept
  • ASP0485
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
Intervention: Drug: Amevive exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00342862
0485-CL-0002, C-739
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Vice President Medical Affairs Astellas Pharma Global Development
Astellas Pharma Inc
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP