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

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07149662
Enrollment
111
Registered
2025-09-02
Start date
2026-02-28
Completion date
2028-03-31
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Pregnancy

Keywords

Multiple Sclerosis, Rituximab, Ocrelizumab, Ofatumumab, monoclonal CD-20 antibodies, Pregnancy

Brief 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

Detailed description

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. 1. 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. 2. 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. 3. 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. 4. 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.

Interventions

DRUGmonoclonal CD-20 antibodies

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

DRUGNo Drug

No medication

Any other immune modulating treatment

Sponsors

The Swedish Research Council
CollaboratorOTHER_GOV
Haukeland University Hospital
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect on infant immune systemAt birthLevels of KREC (copies/micro L) at birth.

Secondary

MeasureTime frameDescription
Drug level concentration infantAt birth - 3 days oldDrug level concentration (microgram/ml) measured from dried blood spots (PKU-test)

Other

MeasureTime frameDescription
Effects on mother´s immune systemFrom enrollment to three months after birthImmunoglobulin (g/L) levels

Countries

Sweden

Contacts

Primary ContactKatharina Fink, MD, Dr. med.
Katharina.fink@regionstockholm.se+46706571789
Backup ContactGreta Mirzaoff, MD
greta.lundborg-mirzaoff@regionstockholm.se08-123 400 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026