Checks immune system in children whose mothers had MS treatment
Studies infants' immune system after mothers take rituximab or similar antibody drugs for multiple sclerosis.
Plain-language title generated from the registry record
Registry title: Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy
Key facts
- Where
- Stockholm, SwedenSee the site
Where in Sweden
- Academic specialist center, Center for NeurologyStockholm, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Stockholm
- Trial code
- NCT07149662
- Record updated
- 25 November 2025
- Original description
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:Read full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: Previous stem cell transplantation.