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A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

NCT04998812 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-15

Study results available
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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.

Conditions

Interventions

DRUG

Ocrelizumab

Post-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling.

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
2022-04-13
Primary Completion
2024-04-08
Completion
2025-07-14
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT04998812 on ClinicalTrials.gov