CTIS2024-510974-25-00进行中（未招募）1 期
A Phase IV, Multicenter, Open-Label Study Evaluating B-Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy – The MINORE Study - MN42988
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Age 18-40 years, inclusive, at screening., Have a diagnosis of MS or CIS (in line with the locally approved indications), Currently pregnant with singleton pregnancy at gestational week = 30 at enrolment, Documentation that first (12-week) and second (18 to 20-week) obstetric ultrasound (prenatal screening) has been conducted before enrolment, Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy (up to gestational week 13 inclusive)
排除标准
- •Last exposure to ocrelizumab >6 months before the woman’s LMP or later than the first trimester (i.e., after gestational week 13), Gestational age at enrolment >30 weeks, Non-singleton pregnancy, Received last dose of ocrelizumab at a different posology other than per the local prescribing information, Social circumstances, that may preclude a woman from participating in the study, Additional exclusions related to obstetric and gynecological health, general health, laboratory findings, and medications
研究者
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