NCT06150781招募中不适用
GENESIS: AIMOVIG® Pregnancy Exposure Registry
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 2,842
- 试验地点
- 1
- 主要终点
- Number of Infants Experiencing Major Congenital Malformations
研究概览
简要总结
The primary objective of this study is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of women with migraine unexposed to erenumeb-aooe.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older (at time of signing the informed consent)
- •Currently pregnant
- •The outcome of the pregnancy must not be known
- •Confirmed clinical diagnosis of migraine
排除标准
- •Women currently participating in another investigational device or investigational drug study, currently taking an investigational medicinal product, or having taken an investigational product within 3 months prior to last menstrual period (LMP) or during pregnancy. Other investigational procedures while participating in this study are excluded.
- •Women exposed to any medications that target the calcitonin gene-related peptide (CGRP) pathway (ie, CGRP monoclonal antibody [mAb] or gepants) in the period from 5 half-lives prior to LMP through the end of pregnancy.
研究组 & 干预措施
Erenumab-aooe-exposed
Pregnant women with confirmed migraine who received erenumab-aooe before or during pregnancy will qualify to be included in the cohort. Dosing and treatment duration of erenumab-aooe as part of this observational study is at the discretion of the healthcare provider (HCP) in accordance with local clinical practice and local labeling.
干预措施: erenumab-aooe (Drug)
结局指标
主要结局
Number of Infants Experiencing Major Congenital Malformations
时间窗: Up to 52 Weeks
次要结局
- Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth(Up to Approximately 38 Weeks)
- Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations(Up to Week 52)
- Percentage of Participants with Maternal Outcomes(Up to Approximately 38 Weeks)
- Number of Women with Pregnancy Complications Following Erenumab-aooe Administration(Week 52)
- Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life(Up to Week 52)
- Percentage of Participants with Fetal Outcomes(Up to Approximately 38 Weeks)
- Percentage of Participants with Infant Outcomes(Up to Week 52)
- Frequency of Major Congenital Malformations of Women with Migraine Exposed to Erenumab-aooe During Pregnancy with Women Representing the Prevalence of Birth Defects in the General Population (External Comparator)(Up to Week 52)
- Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age(Up to Approximately 38 Weeks)
研究者
研究点 (1)
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