2024-510974-25-00招募中4 期
A Phase IV, Multicenter, Open-Label Study Evaluating B-Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy – The MINORE Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- 1. Proportion of infants with B-cell levels (CD19+ cells, absolute counts) below the lower limit of normal (LLN), measured at week 6 of life
研究概览
简要总结
To evaluate whether infants potentially exposed to ocrelizumab during pregnancy present with postpartum B-cell depletion
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase IV Open-Label Study Evaluating B-Cell Levels in Infants Potentially Exposed to Ocrelizumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
1. Proportion of infants with B-cell levels (CD19+ cells, absolute counts) below the lower limit of normal (LLN), measured at week 6 of life
1. Proportion of infants with B-cell levels (CD19+ cells, absolute counts) below the lower limit of normal (LLN), measured at week 6 of life
次要结局
- 1. B-cell levels (CD19+ cells, absolute counts and percentage of lymphocytes) measured at week 6 of life
- 2. Serum concentration of ocrelizumab in the umbilical cord blood at birth
- 3. Serum concentration of ocrelizumab in the infant at week 6 of life
- 4. Mean titers of antibody immune response(s) to vaccination to common childhood vaccinations with full or partial doses given prior to 1 year, which include responses to diphtheria, tetanus, pertussis, Hib, PCV-13, MMR, and HBV
- 5. Proportion of infants with positive humoral response (seroprotective titers; as defined for the individual vaccine) to vaccines
- 6. Serum concentration of ocrelizumab in the mother during pregnancy (time frame of blood sampling: Week 24-30, Week 35) and at delivery (time frame of blood sampling: within 24 hours after delivery)
- 7. Rate and nature of adverse events (AEs) in the mother throughout the study, including changes in clinical and laboratory results
- 8.Rate and nature of AEs in the infant throughout the study, including infections and hospitalizations
- 9. Proportion of pregnancies resulting in live births (term and preterm, with and without congenital anomalies), therapeutic abortions, or stillbirths
- 10. Infant characteristics at birth, including but not limited to body weight, head circumference and length
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (3)
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