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Search / Trial NCT07149662

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

Launched by REGION STOCKHOLM ·

Trial Information

Current as of September 25, 2025

Not yet recruiting

Keywords

Multiple Sclerosis Rituximab Ocrelizumab Ofatumumab Monoclonal Cd 20 Antibodies Pregnancy

ClinConnect Summary

This study is looking at how certain medicines given to women with multiple sclerosis (MS) before or during pregnancy might affect their babies’ immune systems. Specifically, it focuses on treatments called monoclonal CD20 antibodies, like rituximab. Researchers want to find out if these medicines change the baby’s immune cells, make them more likely to get infections, or affect how well vaccines work. They also want to see how long the medicine stays in the mother’s body if she received treatment within a year before getting pregnant.

Women with MS who are planning pregnancy or are pregnant and have been treated with these medicines may be able to join. During pregnancy, the mother will give a few extra blood samples during her regular check-ups. After the baby is born, the child will have a blood test within the first year to check their immune responses to vaccines and infections. The study team will also ask the mother about any infections she or her baby might have had. This study is not yet recruiting participants but will help doctors understand the safety of these MS treatments during pregnancy.

Gender

FEMALE

Eligibility criteria

About Region Stockholm

Region Stockholm is a leading healthcare authority committed to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, Region Stockholm collaborates with hospitals, research institutions, and industry partners to facilitate the development of new therapies and treatment protocols. With a focus on quality, safety, and ethical standards, the organization aims to enhance health outcomes for the diverse population of Stockholm and beyond, leveraging cutting-edge research to translate scientific discoveries into effective healthcare solutions.

Locations

Patients applied

0 patients applied

Trial Officials

Katharina Fink, MD, Dr. med.

Study Director

Karolinska Institutet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported