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

NCT04998812 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: MN429882021-000062-142024-510974-25-00
• Study Type: interventional
• Target: 70
• Locations: 5 countries
• Sites: 11

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

Keywords

ocrelizumab, OCREVUS, placental transfer, pregnancy

Outcome Measures

Primary Outcomes (1)

• Percentage of Infants With B Cell Levels (Cluster of Differentiation 19 [CD19+] Cells) Below the Lower Limit of Normal (LLN)

  The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.

  At Week 6 of infant's life

Secondary Outcomes (25)

• Absolute CD19+ B Cell Count in the Infant Potentially Exposed to Ocrelizumab During Pregnancy

  At Week 6 of infant's life

• Percentage of CD19+ B Cell in the Infant Potentially Exposed to Ocrelizumab During Pregnancy

  At Week 6 of infant's life

• Serum Concentration of Ocrelizumab in the Umbilical Cord Blood at Birth

  Within 1 hour after delivery (at birth, Day 1)

• Serum Concentration of Ocrelizumab in the Infant at Week 6 of Life

  At Week 6 of infant's life

• Serum Concentration of Ocrelizumab in the Mother

  Baseline (gestational Weeks 24-30), gestational Week 35, and at delivery (within 24 hours after delivery) (at birth, Day 1)

Study Arms (2)

Pregnant Women with CIS or MS

EXPERIMENTAL

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.

Drug: Ocrelizumab

Infants

NO INTERVENTION

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.

Interventions

Ocrelizumab DRUG

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

Pregnant Women with CIS or MS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• PPD Development, LP: collaborator
• Laboratory Corporation of America: collaborator
• Illingworth Research Group: collaborator

Study Sites (11)

University of California San Francisco

San Francisco, California, 94158, United States

Location

University Of Colorado

Aurora, Colorado, 80045, United States

Location

The Ken and Ruth Davee department of Neurology

Chicago, Illinois, 60611-4296, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Hopital Pierre Wertheimer - Hopital Neurologique

Bron, 69003, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75013, France

Location

St. Josef Hospital GmbH

Bochum, 44791, Germany

Location

MultipEL Studies - Institut für klinische Studien

Hamburg, 22179, Germany

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 35 pregnant women with singleton pregnancy were enrolled in the study (70 participants in total, including the infants).

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 10, 2021
• Study Start: April 13, 2022
• Primary Completion: April 8, 2024
• Study Completion: July 14, 2025
• Last Updated: April 15, 2026
• Results First Posted: May 22, 2025

Record last verified: 2026-03

Locations

ES (1); FR (2); DE (2); US (4); CH (2)