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Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy

NCT07149662

Not Yet RecruitingN/A

Sponsor: Region Stockholm

Conditions: Multiple Sclerosis, Pregnancy

Interventions: monoclonal CD-20 antibodies, No Drug, Other treatment

Countries: Sweden

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Stockholm, Sweden