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Be Part of Research - Trial Details - A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

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

Not Recruiting

Open to: ALL

Age: 18.0 - 65.0

Medical Conditions

Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2019 Jan 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.

Intervention Arm Group : Ocrelizumab;

Intervention Type : DRUG
Intervention Description : The first dose of placebo will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Salford Royal Hospital
    Salford
    M6 8HD
  • Royal Hallamshire Hospital
    Sheffield
    S10 2JF
  • University Hospital of Wales
    Cardiff
    CF14 4XW
  • The Royal London Hospital
    London
    E1 1BB
  • University of Nottingham
    Nottingham
    NG7 2UH
  • Morriston Hospital
    Swansea
    SA6 6NL
  • Queen Elizabeth University Hospital - PPDS
    Glasgow
    G51 4TF
  • Peninsula College of Medicine and Dentistry
    Plymouth
    PL6 8BX
  • Raigmore Hospital - PPDS
    Inverness
    IV2 3JH
  • The National Hospital for Neurology & Neurosurgery
    London, GT LON
    WC1N 3BG


The study is sponsored by Hoffmann-La Roche





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Read full details for Trial ID: NCT04035005
Last updated 23 April 2025

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