Multiple SclerosisNCT07149662
Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy
An observational study of Multiple Sclerosis and Pregnancy, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Multiple Sclerosis, Pregnancy
- What is being tested?
- monoclonal CD-20 antibodies, No Drug and Other treatment
- How many people
- 111 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with multiple sclerosis that are patients at the Academic specialist center, Center for Neurology, Stockholm, Sweden
Who may be able to join
- 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
Who cannot join
- Previous stem cell transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Academic specialist center, Center for Neurology
Stockholm
Greta Mirzaoff, MD, 08-123 400 00, greta.lundborg-mirzaoff@regionstockholm.se
Greta Mirzaoff, MD
About this study
Official 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)
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?
Read more
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
Read the 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.
- 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.
- Conditions
- Multiple Sclerosis, Pregnancy
- Being tested
- monoclonal CD-20 antibodies, No Drug, Other treatment
- Keywords
- Multiple Sclerosis, Rituximab, Ocrelizumab, Ofatumumab, monoclonal CD-20 antibodies, Pregnancy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monoclonal CD-20 antibodiesDrug
Also called rituximab, ocrelizumab, ofatumumab
Treatment with monoclonal CD-20 antibodies 6 months before or during pregnancy
No DrugDrug
No medication
Other treatmentDrug
Any other immune modulating treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: monoclonal CD-20 antibodies; Drug: No Drug; Drug: Other treatment | |
| Infants born to women with MS | Infants born to women with multiple sclerosis Receives: Drug: monoclonal CD-20 antibodies; Drug: No Drug; Drug: Other treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on infant immune system
Levels of KREC (copies/micro L) at birth.
Measured: At birth
Effect on infant immune system
CD19+ B-cell (nx10^9 cells/L) levels at birth
Measured: At birth
Effect on infant immune system
Infant levels of antibodies (g/L) induced by vaccination or infections
Measured: Age 2 months - 1 year
Effect on infant immune system
Infection during first year of life (n/12 months)
Measured: Age 1 year
Secondary outcomes (1)
Drug level concentration infant
Drug level concentration (microgram/ml) measured from dried blood spots (PKU-test)
Measured: At birth - 3 days old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study startFeb 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- The Swedish Research Council, Haukeland University Hospital, Karolinska Institutet
- Responsible party
- Principal investigator, Katharina Fink, Region Stockholm
- Investigators
- Katharina Fink, MD, Dr. med., Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149662
- Sponsor's protocol ID
- 2024-00763-02
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all pseudoanonymised IPD that underlie results in a future publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07149662
- Acronym / sponsor ID
- 2024-00763-02
- Conditions
- Multiple Sclerosis, Pregnancy
- Keywords
- Multiple Sclerosis, Rituximab, Ocrelizumab, Ofatumumab, monoclonal CD-20 antibodies, Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- The Swedish Research Council, Haukeland University Hospital, Karolinska Institutet
- Study start
- Feb 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with MS during pregnancy | – | Drug: monoclonal CD-20 antibodies, Drug: No Drug, Drug: Other treatmentWomen 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 |
| Infants born to women with MS | – | Drug: monoclonal CD-20 antibodies, Drug: No Drug, Drug: Other treatmentInfants born to women with multiple sclerosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with multiple sclerosis that are patients at the Academic specialist center, Center for Neurology, Stockholm, Sweden
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Previous stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monoclonal CD-20 antibodiesAlso: rituximab, ocrelizumab, ofatumumabTreatment with monoclonal CD-20 antibodies 6 months before or during pregnancy | Drug | Infants born to women with MS, Women with MS during pregnancy |
| No DrugNo medication | Drug | Infants born to women with MS, Women with MS during pregnancy |
| Other treatmentAny other immune modulating treatment | Drug | Infants born to women with MS, Women with MS during pregnancy |
Primary outcome
Effect on infant immune system
Time frame: At birth
Levels of KREC (copies/micro L) at birth.
Effect on infant immune system
Time frame: At birth
CD19+ B-cell (nx10^9 cells/L) levels at birth
Effect on infant immune system
Time frame: Age 2 months - 1 year
Infant levels of antibodies (g/L) induced by vaccination or infections
Effect on infant immune system
Time frame: Age 1 year
Infection during first year of life (n/12 months)
1 secondary outcome
Drug level concentration infant
Time frame: At birth - 3 days old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. We plan to share all pseudoanonymised IPD that underlie results in a future publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katharina Fink, MD, Dr. med. study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Pregnancy, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharina Fink, MD, Dr. med. (+46706571789, Katharina.fink@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on infant immune system (time frame: At birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.