drugset / Trial / NCT04998812
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
Phase 4
Completed
70 enrolled
Hoffmann-La Roche
Illingworth Research Group · collabLaboratory Corporation of America · collabPPD Development, LP · collab
NaSingle-groupOpen-labelOther
Summary
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) \[in line with the locally approved indications\] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.
Timeline
- Start
- 2022-04-13
- Primary completion
- 2024-04-08
- Completion
- 2025-07-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | — | Intravenous |