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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04544436

Public ClinicalTrials.gov record NCT04544436. 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.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 8:28 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 Relapsing 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 RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Study identification

NCT ID
NCT04544436
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
864 participants

Conditions and interventions

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
Nov 25, 2020
Primary completion
Dec 18, 2024
Completion
Aug 30, 2028
Last update posted
Jul 29, 2026

2020 – 2028

United States locations

U.S. sites
25
U.S. states
20
U.S. cities
25
Facility City State ZIP Site status
North Central Neurology Associates Cullman Alabama 35058
Alabama Neurology Associates Homewood Alabama 35209
21st Century Neurology Phoenix Arizona 85004
Profound Research, LLC Carlsbad California 92011
Stanford University Medical Center Stanford California 94305
Advanced Neurology of Colorado, LLC Fort Collins Colorado 80528
Neurology Associates, PA Maitland Florida 32751
University of South Florida Tampa Florida 33612
American Health Network Institute, LLC Avon Indiana 46123
University of Kansas Medical Center Kansas City Kansas 66160
The NeuroMedical Clinic of Central Louisiana Alexandria Louisiana 71301
Maine Medical Center Scarborough Maine 04074
Dragonfly Research, LLC Wellesley Massachusetts 02481
Henry Ford Health System Detroit Michigan 48202
Washington University School of Medicine St Louis Missouri 63110
Cleveland Clinic Lou Ruvo Las Vegas Nevada 89106
Dent Neurological Institute Amherst New York 14226
UC Health Neurology Dayton Ohio 45417
Oklahoma Medical Research Foundation Oklahoma City Oklahoma 73104
Abington Neurological Associates Willow Grove Pennsylvania 19090
Tri-State Mountain Neurology Johnson City Tennessee 37604
Hope Neurology Knoxville Tennessee 37922
Bhupesh Dihenia M.D. P.A. Lubbock Texas 79410
Lone Star Neurology of San Antonio San Antonio Texas 78258
Evergreen MS Center Kirkland Washington 98034

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 95 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04544436, 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 29, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04544436 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →