Not yet recruitingMS (type not specified)NCT07149662

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Rituximab

    B-lymphocyte antigen CD20 binding agent

  • No Drug
  • Other treatment

What it measured

Main measures

  • Effect on infant immune system

    At birth

    Immune response
  • Effect on infant immune system

    Age 2 months - 1 year

  • Effect on infant immune system

    Age 1 year

Other measures (1)

  • Drug level concentration infant

    At birth - 3 days old

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Established multiple sclerosis diagnosis * Rituximab, ocrelizumab, ofatumumab or other monoclonal CD-20 antibody has been administered within 6 (12) months prior to or during pregnancy * Other immun modulation treatment has been administered within 6 (12) months prior to or during pregnancy * No treatment has been administered within 6 (12) months prior to or during pregnancy Exclusion Criteria: - Previous stem cell transplantation

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

Contact details on the registry

About this trial

In the sponsor's words

The goal of this observational study is to learn about consequences for the child when the mother is treated with rituximab (or other monoclonal CD-20 antibodies) before or during pregnancy. The main questions it aims to answer are: * Is the infant's immune system effected with lower levels of B-cell markers, higher rates of infections or poor vaccine response? * Are the monoclonal CD20-antibodies fully eliminated in women treated within 6 (12) months prior to conception? Participants will: * At the time of clinical routine blood sampling (at the end of each trimester) the becoming mother will give some additional blood samples for analysis of drug concentration * Within the first year postpartum the child will leave a blood sample to detect antibodies induced by vaccination or infections * Within our routine contacts with the participant (mother) will be asked about infections in both the mother and the child

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History

    1. Started

      Feb 2026

    2. Main results due

      Oct 2027

    3. Finished

      Mar 2028

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