Immune System Effects in Children Born to Women With Multiple Sclerosis Treated With Monoclonal Antibody Therapy During Pregnancy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRegion Stockholm

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • monoclonal CD-20 antibodies
  • No Drug
  • Other treatment

Treatment groups

111 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Region Stockholm

Lead sponsor

The Swedish Research Council

Collaborator

Haukeland University Hospital

Collaborator

Karolinska Institutet

Collaborator