NCT04998851

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

A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Clinically Isolated Syndrome

Interventions

Type	Name	Description
DRUG	Ocrelizumab	Women will receive the ocrelizumab dose regimen as per the locally-approved label. The ocrelizumab dose will be administered as an initial split dose of two 300 mg infusions separated by 14 days or a single 600 mg infusion according to the local prescribing information.

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-03-29
• Completion: 2025-01-13
• First posted: 2021-08-10
• Last updated: 2026-01-14
• Results posted: 2025-04-16

Locations

8 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study