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B-cell Depletion in Offspring to Women With MS Under Immunomodulatory Treatment

NCT06711354 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2024-12-02

No results posted yet for this study

Summary

The overall aim of the study is to gain knowledge about consequences for the child´s humoral immunosystem in mothers with multiple sclerosis and due to their immunomodulating treatments. Of special interest is when the mother is treated with monoclonal CD20-antibody like rituximab, ocrelizumab and ofatumumab shortly before (within six months prior to conception) and during pregnancy. Specific aims of the study are to:

* Investigate if the humoral immunosystem is fully functioning at birth in children born to mothers with MS
* Investigate if the humoral immunosystem at birth in children born to mothers with MS is influenced by the mothers immunomodulating treatment
* Investigate if monoclonal CD20-antibodies are fully eliminated in women treated with monoclonal CD20-antibodies within 12 months prior to conception.
* Determine if children who have been exposed to monoclonal CD20-antibody in utero have reduced markers of successful B-cell production at birth.
* Investigate the response to the Rota virus vaccine, a life-vaccine that is offered 6 weeks after birth to all children born after September 2019, in children to women treated with rituximab before or during pregnancy.
* Investigate the response to other vaccines (DTP, Polio, HiB, pneumococcus given at 3 and 5 months after birth) the earliest one months after vaccination.
* Investigate the occurrence of infections in the first-year post-partum for the mother and child due to hypogammaglobulinemia, b-cell depletion, and exposure to monoclonal CD20-antibody.
* Investigate if oral exposure to rituximab through mother´s breastmilk is resulting in B-cell reduction in the child.

Conditions

  • Multiple Sclerosis
  • B-Cell Deficiency
  • Offspring, Adult
  • Immunosuppression
  • Pregnancy Related

Interventions

DRUG

Anti-CD20 Monoclonal Antibody

Injection of monoclonal anti-CD20 antibody as immunomodulatory treatment of multiple sclerosis

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Sofia Ernestam, MD, PhD · Karolinska Institutet

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2025-12-31
Completion
2025-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06711354 on ClinicalTrials.gov