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

NCT ID: NCT04998812

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2025-07-14

Brief 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

Multiple Sclerosis; Clinically Isolated Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pregnant Women with CIS or MS

Pregnant women with CIS or MS (in line with the locally approved indications) receiving commercial ocrelizumab up to 6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13), due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice.

Group Type: EXPERIMENTAL

Ocrelizumab

Intervention Type: DRUG

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

Infants

Infants born to women receiving commercial ocrelizumab IV either 0-6 months before the LMP or during the first trimester of pregnancy (up to gestational week 13) due to accidental exposure, or in whom a decision to treat with ocrelizumab was taken as part of routine clinical practice were observed up to month 13 of age.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ocrelizumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MS or CIS (in line with the locally approved indications)
• Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment
• Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
• Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy

Exclusion Criteria

• Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
• Gestational age at enrolment >30 weeks
• Non-singleton pregnancy
• Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
• Lack of access to ultrasound pre-natal care as part of standard clinical practice
• Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
• Pre-pregnancy body mass index >35 kg/m2
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
• Significant and uncontrolled disease that may preclude a woman from participating in the study
• Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies
• Prior or current history of alcohol or drug abuse, or current use of tobacco
• Positive screening tests for hepatitis B
• Treatment with drugs known to have teratogenic effects
• Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
• Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
• Treatment with natalizumab within 12 weeks prior to the LMP
• Treatment with teriflunomide within the last two years, unless measured plasma concentrations are <0.02 mg/L. If levels are >0.02 mg/L or not known, an accelerated elimination procedure is required
• Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Laboratory Corporation of America

INDUSTRY

Sponsor Role: collaborator

Illingworth Research Group

UNKNOWN

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University of California San Francisco

San Francisco, California, United States

University Of Colorado

Aurora, Colorado, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Hopital Pierre Wertheimer - Hopital Neurologique

Bron, , France

Hôpital de la Pitié Salpétrière

Paris, , France

St. Josef Hospital GmbH

Bochum, , Germany

Universitaetsklinikum Carl Gustav Carus an der TU Dresden

Dresden, , Germany

MultipEL Studies - Institut für klinische Studien

Hamburg, , Germany

Hosp. Clinico San Carlos

Madrid, , Spain

Universitätsspital Basel

Basel, , Switzerland

Inselspital Bern

Bern, , Switzerland

Countries

United States; France; Germany; Spain; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-000062-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-510974-25-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MN42988

Identifier Type: -

Identifier Source: org_study_id