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B-cell Depletion in Offspring to Women With MS Under Immunomodulatory Treatment

UnknownN/A

Sponsor: Region Stockholm

Conditions: Multiple Sclerosis, B-Cell Deficiency, Offspring, Adult, Immunosuppression, Pregnancy Related

Interventions: Anti-CD20 Monoclonal Antibody

The overall aim of the study is to gain knowledge about consequences for the child´s humoral immunosystem in mothers with multiple sclerosis and due to their immunomodulating treatments. Of special interest is when the mother is treated with monoclonal CD20-antibody like rituximab, ocrelizumab and ofatumumab shortly before (within six months prior to conception) and during pregnancy. Specific aims of the study are to: * Investigate if the humoral immunosystem is fully functioning at birth in children born to mothers with MS * Investigate if the humoral immunosystem at birth in children born to mothers with MS is influenced by the mothers immunomodulating treatment * Investigate if monoclonal CD20-antibodies are fully eliminated in women treated with monoclonal CD20-antibodies within 12 months prior to conception. * Determine if children who have been exposed to monoclonal CD20-antibody in utero have reduced markers of successful B-cell production at birth. * Investigate the response to the Rota virus vaccine, a life-vaccine that is offered 6 weeks after birth to all children born after September 2019, in children to women treated with rituximab before or during pregnancy. * Investigate the response to other vaccines (DTP, Polio, HiB, pneumococcus given at 3 and 5 months after birth) the earliest one months after vaccination. * Investigate the occurrence of infections in the first-year post-partum for the mother and child due to hypogammaglobulinemia, b-cell depletion, and exposure to monoclonal CD20-antibody. * Investigate if oral exposure to rituximab through mother´s breastmilk is resulting in B-cell reduction in the child.

Eligibility overview

Sex: ALL

Age: — to 50 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Definite diagnosis of multiple sclerosis in mother AND
* Administration of Rituximab, Ocrelizumab or Ofatumumab within 12 months or during established pregnancy OR
* Administration of other immunomodulatory treatment within 12 months or during established pregnancy OR
* No administration of immunomodulatory treatment within 12 months or during established pregnancy

Exclusion Criteria:

* Treatment with stem cell transfusion