An observational study in Multiple Sclerosis and Pregnancy, sponsored by Region Stockholm. Not yet recruiting at 1 site in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Region Stockholm · Observational
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:
Participants will:
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 111 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Region Stockholm is the lead sponsor of 119 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women diagnosed with multiple sclerosis that are patients at the Academic specialist center, Center for Neurology, Stockholm, Sweden
Exclusion Criteria:
- Previous stem cell transplantation
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 multiple sclerosis
Drug: monoclonal CD-20 antibodies · Drug: No Drug · Drug: Other treatment
Treatment with monoclonal CD-20 antibodies 6 months before or during pregnancy
Also known as: rituximab, ocrelizumab, ofatumumab
No medication
Any other immune modulating treatment
Effect on infant immune system
Levels of KREC (copies/micro L) at birth.
Time frame: At birth
Effect on infant immune system
CD19+ B-cell (nx10\^9 cells/L) levels at birth
Time frame: At birth
Effect on infant immune system
Infant levels of antibodies (g/L) induced by vaccination or infections
Time frame: Age 2 months - 1 year
Effect on infant immune system
Infection during first year of life (n/12 months)
Time frame: Age 1 year
Drug level concentration infant
Drug level concentration (microgram/ml) measured from dried blood spots (PKU-test)
Time frame: At birth - 3 days old
Effects on mother´s immune system
Immunoglobulin (g/L) levels
Time frame: From enrollment to three months after birth
Effects on mother´s immune system
B-cell levels nx10\^9/L
Time frame: From enrollment to three months after birth
Effects on mother´s immune system
Drug concentration (microgram/ml)
Time frame: From enrollment to three months after birth
Plan to share: Yes — We plan to share all pseudoanonymised IPD that underlie results in a future publication.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Region Stockholm