drugset / Trial / NCT04998851
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
Phase 4
Completed
26 enrolled
Hoffmann-La Roche
Illingworth Research Group · collabLaboratory Corporation of America · collabPPD Development, LP · collab
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2021-09-16
- Primary completion
- 2024-03-29
- Completion
- 2025-01-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 300 mg | — |
| Subject | Ocrelizumab | Monoclonal antibody | 600 mg | — |