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Continued Access Study for Patients with Neurological Disease Using Ocrelizumab and Drug Combination

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 providing continued access to treatment for patients with a neurological disease. The study involves the use of a medication called Ocrelizumab, which is administered as a concentrate for solution for infusion or as a solution for injection. The purpose of the study is to ensure that patients who were previously enrolled in a related study can continue receiving their treatment if they do not have access to it locally.

In addition to Ocrelizumab, the study also involves other medications, including Lidocaine Hydrochloride Monohydrate, Methylprednisolone Acetate, and Dexamethasone Acetate. These medications are used in various forms, such as oral, intravenous, and subcutaneous routes, to support the treatment of the neurological condition. The study does not provide new treatments but continues the existing therapy for those who have been benefiting from it.

Participants in this study will continue their treatment over a period of time, ensuring they receive the necessary care without interruption. The study is designed to be an extension of previous research, allowing patients to maintain their health and manage their condition effectively. The trial aims to provide a seamless transition for patients who are already on these therapies, ensuring they have ongoing access to their medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study is designed for patients with a neurological disease who were previously enrolled in a related study and do not have access to the treatment locally.
To join, the patient must sign an Informed Consent Form for the extension study.
Eligibility requires that the patient is able to continue the treatment as per the previous study's protocol and benefits from the treatment.
Step 2
Initial assessment
An initial assessment is conducted to ensure the patient can comply with the study protocol.
For women of childbearing potential, a negative urine pregnancy test is required within 24 hours before the first dose of the study treatment.
Step 3
Treatment administration
The treatment involves the administration of Ocrelizumab, also known as Ocrevus, which is given as a solution for injection.
The treatment is administered subcutaneously (under the skin).
The first dose in this extension study must be received within the treatment window allowed by the previous study.
Step 4
Ongoing treatment
The study provides continued access to the treatment for eligible patients.
The treatment continues as long as the patient benefits from it, as assessed by the investigator.
Step 5
Study duration
The estimated end date for the study is July 31, 2029.
The recruitment for the study is expected to start on August 1, 2024.

Who can join the trial?

6 criteria

You must have signed the extension study Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
You need to be eligible to continue on the Roche IMP-based therapy, which is the treatment being studied, at the time of moving from the previous study, according to the rules of that study.
You should receive the first dose of the study treatment in this extension study within the time allowed by the previous study.
You must continue to benefit from the Roche active substance, which is the main ingredient in the treatment, at the time of moving from the previous study, as determined by the study doctor.
You should be able to follow the rules and procedures of the extension study, as judged by the study doctor.
If you are a woman who can become pregnant, you must have a negative urine pregnancy test within 24 hours before receiving the first dose of the study treatment.

Who cannot join the trial?

7 criteria

Patients who do not have a neurological disease. A neurological disease affects the brain, spinal cord, or nerves.
Patients who are not currently receiving treatment in the parent study. The parent study is the original study where the treatment started.
Patients who have reasonable access to the study treatment locally. This means they can get the treatment nearby without needing to join the study.
Patients who are not within the specified age range. The study is for certain age groups only.
Patients who are not part of the specified clinical trial groups. The study is for specific groups of people.
Patients who are not male or female, as the study includes both genders.
Patients who are not considered part of a vulnerable population. A vulnerable population includes people who might need extra protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier De La Cote Basque
Verified
Bayonne, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Centre Hospitalier Universitaire Amiens Picardie
Verified
Amiens, France

Trial locations

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Investigated drugs

Roche IMP(s)-based therapy: This therapy is designed to provide ongoing treatment for patients with a neurological disease who were previously part of a Genentech or F. Hoffmann-La Roche Ltd sponsored study. The goal is to ensure that these patients continue to receive the benefits of the study treatment, especially if they do not have access to it through other means. The specific details of the therapy are not provided, but it is part of an extension study to maintain the treatment effects observed in the original trial.

What is already known about the treatment

Roche IMP – This medication is administered orally and is currently in clinical trials, specifically in an open-label, multicenter extension study. It is being investigated for its potential to treat neurological diseases, providing continued access to treatment for patients who were previously enrolled in related studies. The medication works by targeting specific pathways in the nervous system to help manage symptoms associated with neurological conditions. It falls under the pharmacological classification of neurological agents, focusing on improving nerve function and reducing disease progression.

Investigated diseases

Neurological Disease – Neurological diseases encompass a wide range of disorders affecting the brain, spinal cord, and nerves. These conditions can lead to symptoms such as muscle weakness, coordination problems, and changes in sensation. As the disease progresses, individuals may experience difficulties with movement, speech, and cognitive functions. The progression can vary greatly depending on the specific type of neurological disease. Some conditions may lead to gradual decline, while others might have periods of stability. Understanding the specific nature of the neurological disease is crucial for managing its progression effectively.