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Study on the Physical Impact of Multiple Sclerosis and Continued Access to Ocrelizumab for Patients Previously in a Related Study

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What is this trial about?

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

This clinical trial focuses on studying the effects of Multiple Sclerosis and providing continued access to a treatment called Ocrelizumab. 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 treatment being studied, Ocrelizumab, is available in two forms: a 920 mg solution for injection and a 300 mg concentrate for solution for infusion. The purpose of the study is to understand the physical impact of Multiple Sclerosis from the patient's perspective and to ensure that patients who were previously part of a related study can continue receiving Ocrelizumab.

Participants in this study will receive Ocrelizumab either as an injection under the skin or as an infusion into a vein. The study will last for a period of up to five years, during which the physical effects of Multiple Sclerosis on patients will be evaluated. The study will also monitor the number of participants who continue to receive Ocrelizumab and any side effects they may experience. This study is an extension of previous research, allowing patients who do not have access to Ocrelizumab locally to continue their treatment.

The study aims to gather information on how patients perceive the physical impact of Multiple Sclerosis while continuing their treatment with Ocrelizumab. This information will help in understanding the long-term effects of the treatment and its impact on patients' quality of life. Participants will be monitored for any serious side effects or adverse events that may occur during the study period. The study is designed to provide valuable insights into the management of Multiple Sclerosis and the role of Ocrelizumab in improving patient outcomes.

The research process

The trial runs in 6 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 first step involves signing the extension study informed consent form. This confirms understanding and agreement to participate in the study.

    Eligibility is confirmed based on previous participation in specific studies and the absence of local access to the medication ocrelizumab.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure the ability to comply with the study protocol. This includes a negative urine pregnancy test for women of childbearing potential within 24 hours before the first dose of the study treatment.

  3. Step 3

    First dose administration

    The first dose of ocrelizumab is administered no earlier than 5 months after the last treatment in the previous study. The medication is provided as a 300 mg concentrate for solution for infusion or a 920 mg solution for injection.

  4. Step 4

    Ongoing treatment

    Continued access to ocrelizumab is provided throughout the study. The medication is administered either subcutaneously or intravenously, depending on the specific formulation used.

  5. Step 5

    Monitoring and evaluation

    Regular monitoring is conducted to evaluate the physical impact of multiple sclerosis from the patient's perspective. This includes tracking changes in physical function using specific measurement tools.

    The study also monitors the incidence, nature, severity, and outcomes of any adverse events.

  6. Step 6

    Study completion

    The study is estimated to conclude by July 31, 2029. At the end of the study, changes from baseline in physical function are assessed, and the number of participants who received access to ocrelizumab is recorded.

Who can join the trial?

6 criteria

  • Sign the extension study Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
  • Be a patient who was receiving ongoing treatment with a medication called ocrelizumab in one of the specified previous studies and do not have access to this treatment locally.
  • Receive the first dose of the study treatment in this extension study no earlier than 5 months after the last treatment in the previous study.
  • Be able to follow the study protocol, which is the plan for how the study will be conducted, as judged by the study doctor.
  • If you are a woman who can become pregnant, have a negative urine pregnancy test within 24 hours before receiving the first dose of the study treatment.
  • If you are a woman who can become pregnant, agree to use acceptable birth control methods or remain abstinent during the study and for at least 6 months after the last dose of the study drug. Acceptable methods include certain hormonal contraceptives, condoms, or a combination of methods.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Multiple Sclerosis cannot participate. Multiple Sclerosis is a condition that affects the brain and spinal cord.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or the elderly.
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Investigated drugs

Ocrelizumab is a medication used in the treatment of multiple sclerosis. It works by targeting specific cells in the immune system that are believed to contribute to the damage of nerve cells in patients with multiple sclerosis. This medication is designed to help reduce the physical impact of the disease and improve the quality of life for patients. In this clinical trial, ocrelizumab is provided to patients who have previously participated in related studies and do not have access to a post-trial access program.

What is already known about the treatment

Ocrelizumab – This medication is administered through an intravenous infusion, typically given in a healthcare setting. It is currently approved and widely used in the treatment of multiple sclerosis, with ongoing studies to further understand its impact from the patient's perspective. Ocrelizumab is primarily indicated for the treatment of relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. It 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. Ocrelizumab is classified as a monoclonal antibody, specifically designed to modulate the immune system's activity.

Investigated diseases

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the immune system mistakenly attacks 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 the disease can be unpredictable, with periods of remission and relapses. The severity and specific symptoms can differ greatly from person to person.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507633-21-01Protocol codeMN45053Estimated enrolment278 patientsSponsorF. Hoffmann-La Roche AG

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