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NCT04544436 · 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 Relapsing Multiple Sclerosis (RMS)

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

Active
Registry status
Phase 3
Development phase
864
Enrollment target
20
Study locations

NCT04544436 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 864 participants, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 17 states.

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The verdict

NCT04544436, 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
864 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 RMS, 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)

Alabama

  • North Central Neurology Associates - Cullman
  • Alabama Neurology Associates - Homewood

California

  • Profound Research, LLC - Carlsbad
  • Stanford University Medical Center - Stanford

Florida

  • Neurology Associates, PA - Maitland
  • University of South Florida - Tampa

Arizona

  • 21st Century Neurology - Phoenix

Colorado

  • Advanced Neurology of Colorado, LLC - Fort Collins

Indiana

  • American Health Network Institute, LLC - Avon

Kansas

  • University of Kansas Medical Center - Kansas City

Louisiana

  • The NeuroMedical Clinic of Central Louisiana - Alexandria

Trial Details

FieldValue
Enrollment Target 864 participants
Start Date 2020-11-26
Est. Completion 2028-08-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT04544436

The ClinicalTrials.gov registry entry for NCT04544436 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 864 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 582-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (48% 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.

NCT04544436 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Alabama, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04544436 about?

NCT04544436 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)". 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.

What is the current status of trial NCT04544436?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 864 participants. The study started on 2020-11-26. Estimated completion is 2028-08-31.

What conditions does trial NCT04544436 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT04544436?

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

Who is sponsoring clinical trial NCT04544436?

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

Where is trial NCT04544436 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.