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

NCT04998851 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-14

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • Illingworth Research Group

    collaborator UNKNOWN

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2024-03-29
Completion
2025-01-13
FDA Drug
Yes

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998851 on ClinicalTrials.gov