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Study on Long-Term Safety and Efficacy of Ocrelizumab for Patients with 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 the long-term safety and effectiveness of a medication called Ocrelizumab in patients with Multiple Sclerosis (MS). Multiple Sclerosis is a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The medication being tested, Ocrelizumab, is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how safe Ocrelizumab is for patients over a longer period. Participants in this study have previously been involved in earlier research studies sponsored by the same company. During the study, participants will continue to receive Ocrelizumab and will be monitored for any side effects or changes in their condition. The study will also look at how the medication affects the progression of MS symptoms over time.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that participants might experience. They will also measure changes in the participants' abilities to perform certain tasks, such as walking or using their hands, and will use imaging tests to observe any changes in the brain. This study aims to provide valuable information about the long-term use of Ocrelizumab in managing Multiple Sclerosis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation in this study requires prior eligibility and previous participation in one of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046.

    Participants must have either received ocrelizumab as an investigational medicinal product or been in safety follow-up after treatment discontinuation.

  2. Step 2

    Treatment administration

    The medication used in this study is Ocrevus 300 mg, which is a concentrate for solution for infusion.

    The administration route is through an intravenous infusion.

    The frequency and duration of administration will be determined by the study protocol and the healthcare provider.

  3. Step 3

    Monitoring and assessments

    The primary focus is on the incidence and severity of adverse events, assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Secondary assessments include changes in the Expanded Disability Status Scale (EDSS) score, 9-Hole Peg Test (9HPT), and Timed 25-Foot Walk Test (T25FWT).

    Additional evaluations involve the number of new or enlarging lesions and changes in lesion volumes.

  4. Step 4

    Study duration

    The estimated end date for the study is December 31, 2025.

    The recruitment for the study began on May 10, 2022.

Who can join the trial?

4 criteria

  • The patient must have been eligible for and previously participated in one of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046. This means they either received **ocrelizumab** (a medication used in the study) or were in a safety follow-up after stopping the treatment.
  • For female patients who can have children: They must agree to either not have heterosexual intercourse or use effective birth control during the treatment period and for at least 6 months after the last dose of **ocrelizumab**, or longer if required by local guidelines.
  • Both male and female patients are eligible to participate.
  • The study includes patients who are considered part of a vulnerable population, which means they may need special protection or care.

Who cannot join the trial?

4 criteria

  • Participants who have not been diagnosed with Multiple Sclerosis (MS) cannot join the study. MS is a condition that affects the brain and spinal cord.
  • Participants who were not previously enrolled in Roche-sponsored Phase III pivotal studies for MS cannot participate.
  • Participants who are not within the specified age range for the study cannot join. The age range is not specified here, but it is important for eligibility.
  • Participants who are not able to provide informed consent or who are considered part of a vulnerable population may be excluded. A vulnerable population includes groups like children, pregnant women, or those unable to make decisions for themselves.
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Investigated drugs

Ocrelizumab is a medication used in this clinical trial to evaluate its long-term safety and effectiveness in patients with multiple sclerosis (MS). It is designed to target and reduce certain immune cells that are believed to contribute to the damage of the nervous system in MS. This study is an extension of previous research to ensure that the medication remains safe and effective over a longer period.

What is already known about the treatment

Ocrelizumab – Ocrelizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently approved and widely used in the treatment of Multiple Sclerosis (MS), with ongoing studies to assess its long-term safety and effectiveness. The main therapeutic indication for ocrelizumab is to treat various forms of MS, helping to reduce the frequency of relapses and slow the progression of disability. At the molecular level, ocrelizumab works by targeting and depleting specific immune cells known as B cells, which are believed to play a role in the abnormal immune response seen in MS. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis (MS) is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system mistakenly attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely among individuals and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of MS can be unpredictable, with periods of remission and relapses. The severity and specific symptoms can differ greatly from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505974-14-00Protocol codeMN43964Estimated enrolment1 919 patientsSponsorF. Hoffmann-La Roche AG

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