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NCT04035005 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

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

Active
Registry status
Phase 3
Development phase
1,013
Enrollment target
20
Study locations

NCT04035005 is a Phase 3 study of Multiple Sclerosis, Primary Progressive that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 1,013 participants, above the 342-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (196% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT04035005, a Phase 3 study of Multiple Sclerosis, Primary Progressive, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,013 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).

Conditions Studied

Multiple Sclerosis, Primary Progressive

Interventions

  • DRUG Placebo
  • DRUG Ocrelizumab

Study Locations (20)

Other

  • Cliniques Universitaires St-Luc - Brussels
  • MS & Neurologisch Revalidatie Centrum - Overpelt
  • Military Medical Academy HBAT - Pleven
  • Multiprofile Hospital For Active Treatment Avis Medica - Pleven
  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD - Sofia

Florida

  • MS and Neuromuscular Center of Excellence - Clearwater
  • Neurological Services of Orlando - Orlando
  • Vero Neurology - Vero Beach

Ohio

  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company - Columbus
  • Columbus Neuroscience - Westerville

Victoria

  • Austin Hospital - Heidelberg
  • Royal Melbourne Hospital - Parkville

District of Columbia

  • Georgetown University Medical Center - Washington D.C.

Kansas

  • University of Kansas Medical Center - Kansas City

Pennsylvania

  • Albert Einstein Medical Center - Philadelphia

New South Wales

  • Brain and Mind Research Institute - Camperdown

Trial Details

FieldValue
Enrollment Target 1,013 participants
Start Date 2019-08-12
Est. Completion 2028-01-19
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04035005

The ClinicalTrials.gov registry entry for NCT04035005 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,013 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 342-participant average among 7 other Multiple Sclerosis, Primary Progressive trials with a reported enrollment target (196% 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, Primary Progressive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04035005 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, Ohio.

Frequently Asked Questions

What is clinical trial NCT04035005 about?

NCT04035005 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis". This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatmen...

What is the current status of trial NCT04035005?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,013 participants. The study started on 2019-08-12. Estimated completion is 2028-01-19.

What conditions does trial NCT04035005 study?

This clinical trial studies the following conditions: Multiple Sclerosis, Primary Progressive.

What interventions are being tested in trial NCT04035005?

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

Who is sponsoring clinical trial NCT04035005?

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

Where is trial NCT04035005 being conducted?

This trial has 20 study locations across District of Columbia, Florida, Kansas, Ohio, Pennsylvania. 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.