A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

NCT05269004 · tracked via the Priya Life Science USA tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2022-05-03

Last updated

2026-07-29

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ocrelizumab

Ocrelizumab: Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Study summary

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria * Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet Exclusion criteria * Concurrent participation in any clinical trial (other than the Parent study) * Unable or unwilling to comply with the requirements of the protocol

Primary outcome measure(s)

Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 — Up to 44 months

Trial sites (236)

Facility	City	Region
Barrow Neurological Institute	Phoenix	Arizona
Arizona Neuroscience Research LLC	Phoenix	Arizona
MS Center of California	Laguna Hills	California
Stanford Hospital and Clinics	Palo Alto	California
University of California San Francisco	San Francisco	California
University of California San Francisco	San Francisco	California
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)	Aurora	Colorado
Advanced Neurosciences Research LLC	Fort Collins	Colorado
Neurology Associates PA	Maitland	Florida
University of Miami	Miami	Florida
Neurological Services of Orlando	Orlando	Florida
University of South Florida	Tampa	Florida
Vero Beach Neurology and Research Institute	Vero Beach	Florida
Atlanta Neuroscience Institute	Atlanta	Georgia
Northwestern University	Chicago	Illinois
Consultants in Neurology Ltd	Northbrook	Illinois
Indiana Univ School of Med	Indianapolis	Indiana
Kansas University Medical Center	Kansas City	Kansas
Massachusetts General Hospital	Boston	Massachusetts
Wayne State University	Detroit	Michigan
Henry Ford Hospital	Detroit	Michigan
Michigan Institute for Neurological Disorders	Farmington Hills	Michigan
Minneapolis Clinic of Neurology	Golden Valley	Minnesota
University of Minnesota	Minneapolis	Minnesota
Washington University	St Louis	Missouri
University of Nebraska Medical Center	Omaha	Nebraska
Rutgers New Jersey Medical School Department of Neurology	Newark	New Jersey
Holy Name Hospital	Teaneck	New Jersey
University of New Mexico	Albuquerque	New Mexico
South Shore Neurologic Associates PC	Patchogue	New York
SUNY at Stony Brook	Stony Brook	New York
OnSite Clinical Solutions LLC	Charlotte	North Carolina
The Neurological Institute PA	Charlotte	North Carolina
Atrium Health	Charlotte	North Carolina
Raleigh Neurology Associates	Raleigh	North Carolina
University Neurology Inc.	Cincinnati	Ohio
Columbus Neuroscience	Westerville	Ohio
Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
Providence Neurological Specialties	Portland	Oregon
Abington Neurological Associates	Abington	Pennsylvania

+ 196 more sites — see the full list on the official registry below.

On this site

📄 Ocrevus (ocrelizumab) drug profile →

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Other trials for the same condition

A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS) Active, not recruiting

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) Active, not recruiting

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting

A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring Recruiting

A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05269004 on ClinicalTrials.gov ↗ ← All trials in the USA