Status unknownMS (type not specified)NCT06711354

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Rituximab

    B-lymphocyte antigen CD20 binding agent

What it measured

Main measures

  • KREC and CD19 of B-cells in offspring to mothers with MS exposed to monoclonal anti-CD20 antibodies

    2 years (2022-2023)

    Immune response
  • Antibody production post vaccination in offspring to mothers with MS exposed to monoclonal anti-CD20 antibodies

    4 years (2022-2025)

    Immune response
  • Frequency and severity of infections in mothers with MS exposed to monoclonal anti-CD20 antibodies and their offspring

    4 years (2022-2025)

    Immune response
  • Blood levels of monoclonal anti-CD20 antibodies in offspring to mothers with MS exposed to monoclonal anti-CD20 antibodies before or during pregnancy

    4 years (2022-2025)

    Immune response
  • Levels of monoclonal anti-CD20 antibodies in breastmilk of breastfeeding mothers treated with monoclonal anti-CD20 antibodies in addition to measurement of anti-CD20 antibodies and evaluation of B-cells in blood from the breastfed child

    4 years (2022-2025)

    Immune response

Who could take part

MS (type not specified) · Up to 50

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Jun 2025

    2. Main results due

      Dec 2025

    3. Finished

      Dec 2025

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