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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 Oct 21, 2026, 10:51 PM 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 26, 2020 (Actual)
Primary completion
Dec 19, 2024 (Actual)
Completion
Feb 21, 2028 (Estimated)
Last update posted
Sep 28, 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 Sep 28, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04544436 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →