Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy
What it found
No result yet.
What was tested
Treatment tested
- Rituximab
B-lymphocyte antigen CD20 binding agent
- No Drug
- Other treatment
What it measured
Main measures
Effect on infant immune system
At birth
Immune responseEffect on infant immune system
Age 2 months - 1 year
Effect on infant immune system
Age 1 year
Other measures (1)
Drug level concentration infant
At birth - 3 days old
Who could take part
MS (type not specified) · 18 and over
Inclusion Criteria: * 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 Criteria: - Previous stem cell transplantation
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
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History
Started
Feb 2026
Main results due
Oct 2027
Finished
Mar 2028
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