Assessment and Tracking of Long-Term Alefacept (LFA-3/IgG1 Fusion Protein) Pregnancy Exposure Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Amevive exposure (Drug)
结局指标
主要结局
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
时间窗: At month 4 to 5 of pregnancy; At 2 months and 12 months post estimated delivery date
次要结局
- 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 the number of live born infants versus fetal loss in pregnant women 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)
- 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 malignancies in live born infants exposed to AMEVIVE®(At 2 months and 12 months post estimated delivery date)