MedTrace Logo

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

NCT07149662 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2025-11-25

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

monoclonal CD-20 antibodies

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

DRUG

No Drug

No medication

DRUG

Other treatment

Any other immune modulating treatment

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Haukeland University Hospital

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Katharina Fink, MD, Dr. med. · Karolinska Institutet

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-10-31
Completion
2028-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT07149662 on ClinicalTrials.gov