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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Krajska zdravotni a.s. Teplice Czechia
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Westerstede Germany
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nice Nice France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Universitaire De Caen Normandie Caen France
University Hospital Ostrava Ostrava Czechia
Fjtgqido nekiuexou Mxash a Hrkyazt Prague Czechia
Hajbhfgk Utcgnapwouibww Saghvtzkdl &iipsha Hrbgttr dh Hdkdmavmruw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
01.08.2024
France France
Not yet recruiting
01.08.2024
Germany Germany
Not yet recruiting
01.08.2024

Trial locations

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.

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.

Trial ID:
2023-507633-21-00
Protocol code:
MN45053
Trial Phase:
Therapeutic confirmatory (Phase III)

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