B-cell Depletion in Offspring to Women With MS Under Immunomodulatory Treatment
Launched by REGION STOCKHOLM · Nov 26, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of certain treatments for multiple sclerosis (MS) on the immune system of children born to mothers who have MS. Specifically, it focuses on women who have received specific medications called monoclonal antibodies (like rituximab, ocrelizumab, or ofatumumab) shortly before or during their pregnancy. The researchers want to find out how these treatments might affect the baby’s immune system at birth, how well the baby responds to vaccines, and whether the baby experiences any health issues in their first year of life.
To participate in this study, mothers must have a confirmed diagnosis of MS and have received one of the specified treatments within 12 months before or during their pregnancy. The study is not yet recruiting participants, but it aims to gather important information to help understand how these treatments impact both mothers and their children. Participants can expect to provide health information about themselves and their babies, and the study will assess various health outcomes related to the baby’s immune system and response to vaccines.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Definite diagnosis of multiple sclerosis in mother AND
- • Administration of Rituximab, Ocrelizumab or Ofatumumab within 12 months or during established pregnancy OR
- • Administration of other immunomodulatory treatment within 12 months or during established pregnancy OR
- • No administration of immunomodulatory treatment within 12 months or during established pregnancy
- Exclusion Criteria:
- • Treatment with stem cell transfusion
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Sofia Ernestam, MD, PhD
Study Director
Karolinska Institutet
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported