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Study on the Effectiveness and Safety of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Primary Progressive Multiple Sclerosis (PPMS). This is a type of multiple sclerosis where the disease gradually worsens over time without any periods of improvement. The study is evaluating a treatment called Ocrelizumab, which is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to assess how effective and safe Ocrelizumab is for adults with PPMS. Participants in the study will receive either Ocrelizumab or a placebo, which is a substance with no active medication. The study will monitor the time it takes for participants to experience a progression in their symptoms, such as worsening hand function or an increase in disability, as measured by specific tests. These tests include the 9-Hole Peg Test (9-HPT), which measures hand dexterity, and the Expanded Disability Status Scale (EDSS), which assesses disability in people with multiple sclerosis.

Throughout the study, participants will undergo regular MRI scans to check for changes in the brain and spinal cord. The study will also track any side effects or adverse events that occur. The trial is designed to last for several years, allowing researchers to gather comprehensive data on the long-term effects of Ocrelizumab in treating PPMS.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the diagnosis of primary progressive multiple sclerosis (PPMS) is confirmed according to specific criteria.

    Eligibility is assessed based on factors such as the Expanded Disability Status Scale (EDSS) score and disease duration.

  2. Step 2

    Screening phase

    During the screening phase, magnetic resonance imaging (MRI) scans are conducted to detect specific brain lesions.

    Laboratory tests are performed to check for certain proteins in the cerebrospinal fluid.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either Ocrevus or a placebo.

    The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

  4. Step 4

    Treatment administration

    Ocrevus is administered as an intravenous infusion.

    The dosage is 300 mg, and the infusion is given at specified intervals throughout the study.

  5. Step 5

    Monitoring and assessments

    Regular assessments are conducted to monitor the progression of the disease.

    These include tests like the 9-Hole Peg Test (9-HPT) and evaluations of the EDSS score.

  6. Step 6

    Safety evaluations

    The study monitors for any adverse events or side effects related to the treatment.

    Laboratory tests are repeated to ensure the safety of the participants.

  7. Step 7

    Study completion

    The study is expected to conclude by September 2030.

    Final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

7 criteria

  • Must have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) according to specific medical guidelines.
  • Must have an EDSS score between 3.0 and 8.0. The EDSS score is a way to measure disability in people with multiple sclerosis.
  • The disease must have started less than 20 years ago if the EDSS score is between 7.0 and 8.0, less than 15 years ago if the EDSS score is between 5.5 and 6.5, and less than 10 years ago if the EDSS score is 5.0 or lower.
  • Must have a history or current presence of certain findings in the cerebrospinal fluid, which is the fluid around the brain and spine. This includes an elevated IgG index or the presence of IgG oligoclonal bands, which are specific proteins.
  • Must complete a test called the 9-HPT in more than 25 seconds. The 9-HPT is a hand function test where you place pegs in holes.
  • Must have stable neurological health for at least 30 days before starting the study.
  • Both males and females can participate.

Who cannot join the trial?

9 criteria

  • Patients with any other type of multiple sclerosis besides Primary Progressive Multiple Sclerosis (PPMS) cannot participate. PPMS is a form of multiple sclerosis where symptoms gradually worsen over time.
  • Patients who have had recent infections or are currently experiencing an infection are not eligible.
  • Individuals with a history of cancer, except for certain types of skin cancer, are excluded.
  • Patients who have received certain treatments for multiple sclerosis in the past may not be eligible.
  • Women who are pregnant or breastfeeding cannot participate in the study.
  • Patients with severe heart problems or other serious health conditions are not eligible.
  • Individuals who have had an allergic reaction to similar medications in the past are excluded.
  • Patients who are unable to undergo MRI scans, which are imaging tests used to look at the brain and spinal cord, cannot participate.
  • Individuals who are participating in another clinical trial at the same time are not eligible.
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Investigated drugs

Ocrelizumab is a medication being studied for its effectiveness and safety in treating adults with primary progressive multiple sclerosis. It works by targeting specific cells in the immune system that are believed to play a role in the progression of multiple sclerosis. The goal of the trial is to see if ocrelizumab can slow down the worsening of symptoms in patients compared to those who do not receive the treatment.

What is already known about the treatment

Ocrelizumab – Ocrelizumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently approved and recognized in medical literature for its use in treating primary progressive multiple sclerosis (PPMS). The main therapeutic indication for ocrelizumab is to slow the progression of disability in adults with PPMS. At the molecular level, ocrelizumab works by targeting and depleting CD20-positive B cells, which are believed to play a role in the abnormal immune response that damages the nervous system in multiple sclerosis. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Primary Progressive Multiple Sclerosis (PPMS) – This is a form of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. Unlike other types of multiple sclerosis, PPMS progresses steadily over time, although the rate of progression can vary among individuals. Symptoms may include problems with walking, muscle stiffness, and weakness, as well as issues with balance and coordination. Some individuals may also experience cognitive changes, such as difficulties with memory and concentration. The disease primarily affects the spinal cord and brain, leading to a gradual decline in physical abilities. The exact cause of PPMS is unknown, but it involves an immune-mediated process that damages the protective covering of nerve fibers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505980-36-00Protocol codeWA40404Estimated enrolment1 000 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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