Overview

A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

Status:
Recruiting
Trial end date:
2023-11-08
Target enrollment:
Participant gender:
Summary
This study will evaluate the pharmacokinetics of ocrelizumab in the breastmilk of lactating women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] treated with ocrelizumab, by assessing the concentration of ocrelizumab in mature breastmilk, as well as the corresponding exposure and pharmacodynamic effects (blood B cell levels) in the infants.
Phase:
Phase 4
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborators:
Illingworth
LabCorp
PPD
Treatments:
Ocrelizumab