ClinConnect ClinConnect Logo
Search / Trial NCT06711354

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.

Locations

Patients applied

0 patients applied

Trial Officials

Sofia Ernestam, MD, PhD

Study Director

Karolinska Institutet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported