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Study on the Effectiveness and Safety of Ocrelizumab, Methylprednisolone, and Diphenhydramine Hydrochloride in Patients with Multiple Sclerosis

Verified siteRegistered drugNo placebo
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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 effectiveness and safety 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 study involves patients who have previously participated in a related clinical trial sponsored by the pharmaceutical company Roche.

The purpose of this study is to evaluate how well Ocrelizumab works in managing MS symptoms and its safety over time. Participants will receive the medication through an intravenous infusion, which means it is administered directly into the bloodstream. The study will monitor various aspects of the disease, including any changes in disability levels, the occurrence of relapses, and overall disease activity. Additionally, the study will use MRI scans to observe changes in the brain that are associated with MS.

Throughout the study, participants will be regularly assessed to track their progress and any side effects they may experience. The study aims to provide valuable information on the long-term use of Ocrelizumab in treating MS, helping to improve understanding of its benefits and risks for patients living with this condition.

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

    Initial visit and assessment

    Upon joining the study, an initial visit is conducted to assess eligibility. This includes a review of medical history and current health status.

    A series of tests and evaluations are performed to establish a baseline for the study. These may include physical examinations, neurological assessments, and laboratory tests.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of methylprednisolone 500 mg as a solution for injection or infusion. This is given intravenously to prepare the body for the main treatment.

    Following this, diphenhydramine hydrochloride 50 mg tablets are taken orally to help manage potential allergic reactions.

  3. Step 3

    Ocrelizumab infusion

    The main treatment involves the infusion of ocrelizumab 300 mg. This is administered as a solution for infusion through a vein.

    The infusion process is monitored closely to ensure safety and manage any immediate side effects.

  4. Step 4

    Supportive medication

    To manage any discomfort or fever, paracetamol 1000 mg is taken orally as needed.

    This medication helps in reducing fever and alleviating pain that may occur during the treatment.

  5. Step 5

    Follow-up visits

    Regular follow-up visits are scheduled to monitor progress and assess the effectiveness of the treatment.

    These visits include physical examinations, neurological assessments, and possibly additional laboratory tests to track changes in health status.

  6. Step 6

    Ongoing monitoring

    Throughout the study, continuous monitoring is conducted to evaluate the impact of the treatment on multiple sclerosis symptoms.

    This includes tracking any changes in disability progression, relapse rates, and overall quality of life.

  7. Step 7

    Final assessment

    At the end of the study period, a final assessment is performed to determine the overall effectiveness and safety of the treatment.

    This includes a comprehensive review of all collected data and a final evaluation of health status.

Who can join the trial?

5 criteria

  • The patient must be able to follow the study rules, as judged by the study doctor.
  • The patient must be eligible to continue into the MN39158/LIBERTO study. This includes women who were pregnant during earlier studies and are still being monitored for safety, based on the study doctor's decision after assessing the risks and benefits of continuing treatment with ocrelizumab (a medication used to treat MS).
  • The patient must meet the criteria to receive more treatment with ocrelizumab.
  • If a patient became pregnant by chance between the last visit of the previous study and the start of this study, confirmed by pregnancy tests, they will enter a safety follow-up immediately and restart treatment after giving birth and finishing breastfeeding, according to the re-treatment criteria.
  • Women who can become pregnant must agree to either not have sexual intercourse or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the last dose of ocrelizumab, as stated in the local guidelines for the medication.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously enrolled in a Roche sponsored phase IIIb/IV-trial for multiple sclerosis.
  • Patients with any other significant health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have received any live vaccines within the last 4 weeks.
  • Patients with active infections that require treatment.
  • Patients with a history of cancer, except for certain types of skin cancer.
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Investigated drugs

Ocrelizumab is a medication used in the treatment of multiple sclerosis (MS), a condition where the immune system mistakenly attacks the protective covering of nerves. This medication works by targeting and reducing certain immune cells in the body that are believed to play a role in the damage caused by MS. By doing so, it helps to slow down the progression of the disease and reduce the frequency of relapses, which are periods when symptoms get worse. In this clinical trial, the effectiveness and safety of ocrelizumab are being evaluated in patients who have already participated in a previous study involving this medication.

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 drip. It is currently recognized in medical literature as a treatment for multiple sclerosis (MS), a condition where the immune system attacks the protective covering of nerves. The main therapeutic use of ocrelizumab is to reduce the frequency of relapses and slow the progression of disability in MS patients. At the molecular level, ocrelizumab works by targeting and depleting certain immune cells called 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, a type of protein designed to bind to specific targets in the body.

Investigated diseases

Multiple sclerosis (MS) – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. As the disease progresses, it can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely 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 new symptoms or relapses that can last for days or months, followed by periods of remission. Over time, some people with MS may experience a gradual worsening of symptoms and disability.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506543-41-00Protocol codeMN39158Estimated enrolment905 patientsSponsorF. Hoffmann-La Roche AG

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