Status:
NOT_YET_RECRUITING
Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy
Lead Sponsor:
Region Stockholm
Collaborating Sponsors:
The Swedish Research Council
Haukeland University Hospital
Conditions:
Multiple Sclerosis
Pregnancy
Eligibility:
FEMALE
18+ years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT07149662
Start Date
February 1 2026
End Date
March 1 2028
Last Update
November 25 2025
Active Locations (1)
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1
Academic specialist center, Center for Neurology
Stockholm, Sweden