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
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
None
Women diagnosed with multiple sclerosis that are patients at the Academic specialist center, Center for Neurology, Stockholm, Sweden
Cohort
Prospective
monoclonal CD-20 antibodies
DrugTreatment with monoclonal CD-20 antibodies 6 months before or during pregnancy
No Drug
DrugNo medication
Other treatment
DrugAny other immune modulating treatment
Effect on infant immune system
Levels of KREC (copies/micro L) at birth.
Effect on infant immune system
CD19+ B-cell (nx10\^9 cells/L) levels at birth
Effect on infant immune system
Infant levels of antibodies (g/L) induced by vaccination or infections
Effect on infant immune system
Infection during first year of life (n/12 months)
Drug level concentration infant
Drug level concentration (microgram/ml) measured from dried blood spots (PKU-test)
Effects on mother´s immune system
Immunoglobulin (g/L) levels
Effects on mother´s immune system
B-cell levels nx10\^9/L
Effects on mother´s immune system
Drug concentration (microgram/ml)
Click on the lead sponsor to view all of their trials.
Region Stockholm
Lead sponsor
The Swedish Research Council
Collaborator
Haukeland University Hospital
Collaborator
Karolinska Institutet
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
