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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| Haukeland University Hospital | OTHER |
| Karolinska Institutet | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Infants born to women with MS | Infants born to women with multiple sclerosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monoclonal CD-20 antibodies | Drug | Treatment with monoclonal CD-20 antibodies 6 months before or during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Drug level concentration infant | Drug level concentration (microgram/ml) measured from dried blood spots (PKU-test) | At birth - 3 days old |
| Measure | Description | Time Frame |
|---|---|---|
| Effects on mother“s immune system | Immunoglobulin (g/L) levels | From enrollment to three months after birth |
| Effects on mother“s immune system | B-cell levels nx10^9/L |
Inclusion Criteria:
Exclusion Criteria:
- Previous stem cell transplantation
Able to become pregnant and deliver a child
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Women diagnosed with multiple sclerosis that are patients at the Academic specialist center, Center for Neurology, Stockholm, Sweden
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharina Fink, MD, Dr. med. | Contact | +46706571789 | Katharina.fink@regionstockholm.se | |
| Greta Mirzaoff, MD | Contact | 08-123 400 00 | greta.lundborg-mirzaoff@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Katharina Fink, MD, Dr. med. | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic specialist center, Center for Neurology | Stockholm | Sweden |
We plan to share all pseudoanonymised IPD that underlie results in a future publication.
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|
| No Drug | Drug | No medication |
|
| Other treatment | Drug | Any other immune modulating treatment |
|
| From enrollment to three months after birth |
| Effects on mother“s immune system | Drug concentration (microgram/ml) | From enrollment to three months after birth |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C533411 | ocrelizumab |
| C527517 | ofatumumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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