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NCT04548999 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Multiple Sclerosis, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 3
Development phase
769
Enrollment target
20
Study locations

NCT04548999 is a Phase 3 study of Multiple Sclerosis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 769 participants, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04548999, a Phase 3 study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
769 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Multiple Sclerosis

Interventions

  • DRUG Methylprednisolone
  • DRUG Ocrelizumab
  • DRUG Antihistamine

Study Locations (20)

California

  • University of California Irvine - Irvine
  • Stanford University Medical Center - Stanford

Colorado

  • University of Colorado Denver - Aurora
  • Advanced Neurosciences Research LLC - Fort Collins

Florida

  • MS and Neuromuscular Center of Excellence - Clearwater
  • University of South Florida - Tampa

Massachusetts

  • Massachusetts General Hospital. - Boston
  • University of Massachusetts Medical School - Worcester

New York

  • Northwell Health - Great Neck
  • Lenox Hill Hospital - New York

Tennessee

  • Neurology Clinic PC - Cordova
  • Advanced Neurosciences Institute - Nashville

Alabama

  • Alabama Neurology Associates - Homewood

Arizona

  • 21st Century Neurology - Phoenix

Trial Details

FieldValue
Enrollment Target 769 participants
Start Date 2020-12-03
Est. Completion 2027-09-08
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT04548999

The ClinicalTrials.gov registry entry for NCT04548999 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 769 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 583-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (32% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Methylprednisolone is the first listed.

NCT04548999 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT04548999 about?

NCT04548999 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)". 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.

What is the current status of trial NCT04548999?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 769 participants. The study started on 2020-12-03. Estimated completion is 2027-09-08.

What conditions does trial NCT04548999 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT04548999?

The interventions under investigation include: Methylprednisolone (DRUG), Ocrelizumab (DRUG), Antihistamine (DRUG).

Who is sponsoring clinical trial NCT04548999?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04548999 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.