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

NCT07149662 | Not Yet Recruiting

• 1 other identifier: 2024-00763-02
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis; Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Effect on infant immune system

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

  At birth

• Effect on infant immune system

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

  At birth

• Effect on infant immune system

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

  Age 2 months - 1 year

• Effect on infant immune system

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

  Age 1 year

Secondary Outcomes (1)

• Drug level concentration infant

  At birth - 3 days old

Other Outcomes (3)

• Effects on mother´s immune system

  From enrollment to three months after birth

• Effects on mother´s immune system

  From enrollment to three months after birth

• Effects on mother´s immune system

  From enrollment to three months after birth

Study Arms (2)

Women with MS during pregnancy

Women over 18 years of age with the diagnosis of multiple sclerosis, regardless of treatment, or no treatment, that have successfully delivered or will deliver a child

Drug: monoclonal CD-20 antibodies; Drug: No Drug; Drug: Other treatment

Infants born to women with MS

Infants born to women with multiple sclerosis

Drug: monoclonal CD-20 antibodies; Drug: No Drug; Drug: Other treatment

Interventions

monoclonal CD-20 antibodies DRUG

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

Also known as: rituximab, ocrelizumab, ofatumumab

Infants born to women with MS; Women with MS during pregnancy

No Drug DRUG

No medication

Infants born to women with MS; Women with MS during pregnancy

Other treatment DRUG

Any other immune modulating treatment

Infants born to women with MS; Women with MS during pregnancy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Able to become pregnant and deliver a child
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with multiple sclerosis that are patients at the Academic specialist center, Center for Neurology, Stockholm, Sweden

You may qualify if:

• 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

You may not qualify if:

• \- Previous stem cell transplantation

Sponsors & Collaborators

• Region Stockholm: lead
• The Swedish Research Council: collaborator
• Haukeland University Hospital: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Academic specialist center, Center for Neurology

Stockholm, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Rituximab; ocrelizumab; ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Katharina Fink, MD, Dr. med.

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Katharina Fink, MD, Dr. med.

CONTACT

+46706571789; Katharina.fink@regionstockholm.se

Greta Mirzaoff, MD

CONTACT

08-123 400 00; greta.lundborg-mirzaoff@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Dr. med.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 2, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)