Academic specialist center, Center for Neurology
Stockholm, Sweden
Location contact
Greta Mirzaoff, MD
CONTACT
Greta Mirzaoff, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07149662
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
Trial opening soon.
Get Notified18 year and older
Female
Observational
Stockholm, Sweden
Greta Mirzaoff, MD
CONTACT
Greta Mirzaoff, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment with monoclonal CD-20 antibodies 6 months before or during pregnancy
Other names: rituximab, ocrelizumab, ofatumumab
No medication
Any other immune modulating treatment
Time frame: At birth
Levels of KREC (copies/micro L) at birth.
Time frame: At birth
CD19+ B-cell (nx10^9 cells/L) levels at birth
Time frame: Age 2 months - 1 year
Infant levels of antibodies (g/L) induced by vaccination or infections
Time frame: Age 1 year
Infection during first year of life (n/12 months)
Time frame: At birth - 3 days old
Drug level concentration (microgram/ml) measured from dried blood spots (PKU-test)
Time frame: From enrollment to three months after birth
Immunoglobulin (g/L) levels
Time frame: From enrollment to three months after birth
B-cell levels nx10^9/L
Time frame: From enrollment to three months after birth
Drug concentration (microgram/ml)
Contact information is provided by the study sponsor or research team.
Greta Mirzaoff, MD
CONTACT
Katharina Fink, MD, Dr. med.
CONTACT
Region Stockholm
Other Gov
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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