Clinical trial NCT00342862: AMEVIVE® Pregnancy Registry
Official title: Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Keywords: Pregnancy
Amevive
alefacept
Registry
Psoriasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-06-21
Enrollment: 3
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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 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

Primary outcomes:
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
timeFrame: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
Secondary outcomes:
measure: To evaluate the number of live born infants versus fetal loss in pregnant women exposed to AMEVIVE®
timeFrame: At 2 months post estimated delivery date
measure: To evaluate gestational age, body weight, gender, head circumference, and body length in live born infants exposed to AMEVIVE®
timeFrame: At 2 months post estimated delivery date
measure: To evaluate appearance, pulse, grimace, activity, and respiration (APGAR) scores at 1 and 5 minutes of age in live born infants exposed to AMEVIVE®
timeFrame: At 2 months post estimated delivery date
measure: To evaluate hospitalizations for infection in live born infants exposed to AMEVIVE®
timeFrame: At 2 months and 12 months post estimated delivery date
measure: To evaluate clinically significant infections with unusual organisms, not requiring hospitalization in live born infants exposed to AMEVIVE®
timeFrame: At 2 months and 12 months post estimated delivery date
measure: To evaluate malignancies in live born infants exposed to AMEVIVE®
timeFrame: At 2 months and 12 months post estimated delivery date
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: INC Research
state: North Carolina
Study officials:
affiliation: Astellas Pharma Global Development
name: Vice President Medical Affairs
role: STUDY_DIRECTOR
References: