A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

ClinicalTrials.gov ID: NCT04548999

Public ClinicalTrials.gov record NCT04548999. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 4:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase IIIB Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Study identification

NCT ID: NCT04548999
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 769 participants

Conditions and interventions

Conditions

Multiple Sclerosis

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 3, 2020 (Actual)
Primary completion: Jun 30, 2025 (Actual)
Completion: Sep 8, 2027 (Estimated)
Last update posted: Jul 24, 2026

2020 – 2027

United States locations

U.S. sites: 24
U.S. states: 16
U.S. cities: 24

Facility	City	State	ZIP	Site status
Alabama Neurology Associates	Homewood	Alabama	35209	—
21st Century Neurology	Phoenix	Arizona	85004	—
University of California Irvine	Irvine	California	92697	—
Stanford University Medical Center	Stanford	California	94305	—
University of Colorado Denver	Aurora	Colorado	80045	—
Advanced Neurosciences Research LLC	Fort Collins	Colorado	80524	—
MS and Neuromuscular Center of Excellence	Clearwater	Florida	33761	—
University of South Florida	Tampa	Florida	33612	—
Baptist Health Lexington	Nicholasville	Kentucky	40356	—
International Neurorehabilitation Institute	Lutherville	Maryland	21093	—
Massachusetts General Hospital.	Boston	Massachusetts	02114	—
University of Massachusetts Medical School	Worcester	Massachusetts	01655	—
Michigan Institute for Neurological Disorders	Farmington Hills	Michigan	48334	—
Washington University School of Medicine	St Louis	Missouri	63110	—
Jersey Shore University Medical Centre	Neptune City	New Jersey	07753	—
Northwell Health	Great Neck	New York	11021	—
Lenox Hill Hospital	New York	New York	10075	—
Cleveland Clinic	Cleveland	Ohio	44195	—
Neurology Clinic PC	Cordova	Tennessee	38018	—
Advanced Neurosciences Institute	Nashville	Tennessee	37205	—
University of Texas Southwestern Medical Center	Dallas	Texas	75390	—
Lone Star Neurology of San Antonio	San Antonio	Texas	78258	—
Texas Institute for Neurological Disorders	Sherman	Texas	75092	—
Wheaton Franciscan Healthcare - St. Francis Outpatient Center	Milwaukee	Wisconsin	53215	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 123 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04548999, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 24, 2026 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04548999 live on ClinicalTrials.gov.

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