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NCT Number: NCT07149662

Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Academic specialist center, Center for Neurology

Stockholm, Sweden

Location contact

Greta Mirzaoff, MD

CONTACT

[email protected]

08-123 400 00

Greta Mirzaoff, MD

PRINCIPAL_INVESTIGATOR

About this study

In offspring to women with MS and current pregnancies the investigators will address if a reduction in the levels of KREC (kappa-deleting recombination excision circles) and/or CD19+ B-cells at birth has clinical significance. Participants with MS regardless of treatment that have successfully delivered or will deliver a child will be asked for informed consent and after given informed consent they will be included in the study.

  • At the time of clinical routine sampling in the becoming mother the investigators will collect additional blood samples. Routine analysis collects information on immunoglobulin levels and b-cell levels, additional blood samples will allow analysis of drug concentration at the end of every trimester.
  • Within the first year postpartum, but earliest one month after vaccination, the investigators will ask for a blood sample from the child to detect antibodies induced by vaccination or infections to secure the ability to develop antibodies despite being exposed to monoclonal CD20-antibodies in-utero or via breastmilk. All children followed by the Specialist outpatient clinic for children in Liljeholmen - a specialist clinic from the Karolinska University Hospital following children to mothers on immunosuppressant/immunomodulating treatments regardless of disease, will be offered blood sampling by routine months 2, 6 and 1 year postpartum. In collaboration with this center, the investigators will get samples taken and analyzed within clinical routine.
  • PKU-test is taken in the child within routine but additional analysis on drug levels and KREC will be analyzed as well as determining abundance of CD19 transcripts.
  • Within the routine contacts with the MS patient (mother) the investigators will ask for infections in both, the mother and the child at 3 months and 1 year post-partum.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monoclonal CD-20 antibodies

Drug

Treatment with monoclonal CD-20 antibodies 6 months before or during pregnancy

Other names: rituximab, ocrelizumab, ofatumumab

No Drug

Drug

No medication

Other treatment

Drug

Any other immune modulating treatment

Primary outcomes

  1. Effect on infant immune system

    Time frame: At birth

    Levels of KREC (copies/micro L) at birth.

  2. Effect on infant immune system

    Time frame: At birth

    CD19+ B-cell (nx10^9 cells/L) levels at birth

  3. Effect on infant immune system

    Time frame: Age 2 months - 1 year

    Infant levels of antibodies (g/L) induced by vaccination or infections

  4. Effect on infant immune system

    Time frame: Age 1 year

    Infection during first year of life (n/12 months)

Secondary outcomes

  1. Drug level concentration infant

    Time frame: At birth - 3 days old

    Drug level concentration (microgram/ml) measured from dried blood spots (PKU-test)

Other outcomes

  1. Effects on mother´s immune system

    Time frame: From enrollment to three months after birth

    Immunoglobulin (g/L) levels

  2. Effects on mother´s immune system

    Time frame: From enrollment to three months after birth

    B-cell levels nx10^9/L

  3. Effects on mother´s immune system

    Time frame: From enrollment to three months after birth

    Drug concentration (microgram/ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Greta Mirzaoff, MD

CONTACT

[email protected]

08-123 400 00

Katharina Fink, MD, Dr. med.

CONTACT

[email protected]

+46706571789

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Haukeland University Hospital
  • Karolinska Institutet
  • The Swedish Research Council

Registry information

Official study title

B-cellspåverkan i Barn Till Kvinnor Med Multipel Skleros Och Rituximabbehandling före Eller Under Graviditeten (B-cell Effects in Children Born to Women With Multiple Sclerosis and Rituximab Treatment Before or During Pregnancy)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 2, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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