NL-OMON40792已完成不适用
A MULTICENTER POSTMARKETING STUDY TO EVALUATE THE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL IN PREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA® (CERTOLIZUMAB PEGOL) - UP0017
CB Biosciences Inc.0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is >=30 weeks pregnant with a singleton or twins at the time of informed
- •consent/assent.
- •2. Subject is being treated with CZP at a dose and administration schedule per the locally
- •approved label.
- •3. Subject started, or decided to start, treatment with CZP independently from and prior to being
- •recruited for this study and in accordance with the treating physician.
- •4. Subject expects to receive CZP until at least 35 days prior to expected delivery.
- •Additional criteria to be confirmed at Visit 2 (delivery):
- •5. Subject delivers a live born infant at or near term (>=34 weeks gestation).
- •6. Subject received CZP within 35 days before delivery.
排除标准
- •1. Subject has a positive or indeterminate QuantiFERON®-TB GOLD In Tube test at Screening.
- •In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate
- •require exclusion of the subject (see also exclusion criterion 11 - definition of latent
- •tuberculosis [LTB]). Tuberculosis (TB) test results that have been obtained within the
- •previous 60 days prior to Screening are acceptable (QuantiFERON®-TB GOLD or purified
- •protein derivative [PPD] test).
- •2. Subject has known TB infection, at high risk of acquiring TB infection, or latent TB
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