WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Birth defects
研究概览
简要总结
This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
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
- •Pregnant women containing sufficient evidence to confirm that exposure to commercially supplied belimumab occurred within the 4 months prior to and/or during pregnancy
- •Pregnant women with sufficient information to classify the pregnancy as prospective or retrospective (ie,whether the outcome of pregnancy was known at the time of first contact with the registry)
- •Pregnant women with full contact information to allow for follow-up (name, address, telephone number/email address) and contact information for applicable HCPs if initial reporter is the pregnant woman
- •Consent provided by the pregnant woman for her participation and assent for participation of her infant.
排除标准
- •Reported cases that do not meet the minimum inclusion criteria for registry enrollment will be ineligible for inclusion in the registry
研究组 & 干预措施
Pregnant women taking belimumab
Any women with belimumab exposure within the 4 months prior to and/or during pregnancy
干预措施: belimumab (Drug)
Infants
Infants through the first year of life whose mothers were exposed to belimumab during pregnancy
干预措施: belimumab (Drug)
结局指标
主要结局
Birth defects
时间窗: Up to one year after birth
The registry will define and code birth defects with criteria specified by Centers for Disease Control and Prevention (CDC)'s Metropolitan Atlanta Congenital Defects Program (MACDP)
次要结局
- Other pregnancy outcomes(At birth)
- Infant outcomes(Up to 1 year after birth)