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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Multiprofile Hospital For Active Treatment Avis Medika OOD Pleven Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Lyon Sud Pierre Benite France
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Centre Hospitalier Universitaire De Caen Normandie Caen France
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany
Brjlirns Ukshpzcsle Havtykof Cvpxlk Besançon France
Cttv Dd Ncswy Vandoeuvre Les Nancy France
Mnabexdl Mrkdeyd Awcoesw Pleven Bulgaria
Hifhltju Ubicfiihoevdyl Stzxueouyf &yzvcyx Hlidpwe dj Hdgyzuopadf STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
06.10.2024
France France
Recruiting
06.10.2024
Germany Germany
Recruiting
06.10.2024

Trial locations

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.

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 ID:
2023-507633-21-01
Protocol code:
MN45053
Trial Phase:
Therapeutic confirmatory (Phase III)

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