B-cellspåverkan i Barn Till Kvinnor Med Multipel Skleros Och Rituximabbehandling före Eller Under Graviditeten (B-cell Effects in Children Born to Women With Multiple Sclerosis and Rituximab Treatment Before or During Pregnancy)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Effect on infant immune system
研究概览
简要总结
The goal of this observational study is to learn about consequences for the child when the mother is treated with rituximab (or other monoclonal CD-20 antibodies) before or during pregnancy. The main questions it aims to answer are:
- Is the infant's immune system effected with lower levels of B-cell markers, higher rates of infections or poor vaccine response?
- Are the monoclonal CD20-antibodies fully eliminated in women treated within 6 (12) months prior to conception?
Participants will:
- At the time of clinical routine blood sampling (at the end of each trimester) the becoming mother will give some additional blood samples for analysis of drug concentration
- Within the first year postpartum the child will leave a blood sample to detect antibodies induced by vaccination or infections
- Within our routine contacts with the participant (mother) will be asked about infections in both the mother and the child
详细描述
In offspring to women with MS and current pregnancies the investigators will address if a reduction in the levels of KREC (kappa-deleting recombination excision circles) and/or CD19+ B-cells at birth has clinical significance. Participants with MS regardless of treatment that have successfully delivered or will deliver a child will be asked for informed consent and after given informed consent they will be included in the study.
- At the time of clinical routine sampling in the becoming mother the investigators will collect additional blood samples. Routine analysis collects information on immunoglobulin levels and b-cell levels, additional blood samples will allow analysis of drug concentration at the end of every trimester.
- Within the first year postpartum, but earliest one month after vaccination, the investigators will ask for a blood sample from the child to detect antibodies induced by vaccination or infections to secure the ability to develop antibodies despite being exposed to monoclonal CD20-antibodies in-utero or via breastmilk. All children followed by the Specialist outpatient clinic for children in Liljeholmen - a specialist clinic from the Karolinska University Hospital following children to mothers on immunosuppressant/immunomodulating treatments regardless of disease, will be offered blood sampling by routine months 2, 6 and 1 year postpartum. In collaboration with this center, the investigators will get samples taken and analyzed within clinical routine.
- PKU-test is taken in the child within routine but additional analysis on drug levels and KREC will be analyzed as well as determining abundance of CD19 transcripts.
- Within the routine contacts with the MS patient (mother) the investigators will ask for infections in both, the mother and the child at 3 months and 1 year post-partum.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Established multiple sclerosis diagnosis
- •Rituximab, ocrelizumab, ofatumumab or other monoclonal CD-20 antibody has been administered within 6 (12) months prior to or during pregnancy
- •Other immun modulation treatment has been administered within 6 (12) months prior to or during pregnancy
- •No treatment has been administered within 6 (12) months prior to or during pregnancy
排除标准
- •- Previous stem cell transplantation
研究组 & 干预措施
Women with MS during pregnancy
Women over 18 years of age with the diagnosis of multiple sclerosis, regardless of treatment, or no treatment, that have successfully delivered or will deliver a child
干预措施: monoclonal CD-20 antibodies (Drug)
Women with MS during pregnancy
Women over 18 years of age with the diagnosis of multiple sclerosis, regardless of treatment, or no treatment, that have successfully delivered or will deliver a child
干预措施: No Drug (Drug)
Women with MS during pregnancy
Women over 18 years of age with the diagnosis of multiple sclerosis, regardless of treatment, or no treatment, that have successfully delivered or will deliver a child
干预措施: Other treatment (Drug)
Infants born to women with MS
Infants born to women with multiple sclerosis
干预措施: monoclonal CD-20 antibodies (Drug)
Infants born to women with MS
Infants born to women with multiple sclerosis
干预措施: No Drug (Drug)
Infants born to women with MS
Infants born to women with multiple sclerosis
干预措施: Other treatment (Drug)
结局指标
主要结局
Effect on infant immune system
时间窗: Age 1 year
Infection during first year of life (n/12 months)
次要结局
- Drug level concentration infant(At birth - 3 days old)
研究者
Katharina Fink
MD, Dr. med.
Region Stockholm