A Single Arm, Open Label Multicentre Extension Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trial
This study is an extension of previous research into a medicine called ocrelizumab, used for multiple sclerosis (MS). It's designed for people who have already received ocrelizumab in earlier studies. The main goal is to keep checking how effective the medicine is at slowing down MS progression and to make sure it remains safe over a longer period. Researchers will look at changes in disability, how often relapses occur, and other measures of MS activity. The study aims to gather more information on the long-term effects of ocrelizumab in a real-world setting, helping health professionals understand how best to use it to manage MS.
At a glance
What is this study about?
This study is a continuation of research into a medication called ocrelizumab, which is used to treat Multiple Sclerosis (MS). Think of it as a follow-up study for people who have already been taking ocrelizumab in a previous clinical trial. The main purpose is to see how well the medicine continues to work and if it's safe over a longer period of time. This helps doctors and researchers understand the long-term benefits and any potential side effects.
Researchers will be carefully watching various aspects of MS. This includes looking at whether your disability gets better, stays the same, or worsens over time. They'll also track things like how many MS relapses you might have and if there are any signs of new MS activity. By collecting this information, the study aims to confirm that ocrelizumab is an effective and safe treatment for MS when used over an extended period.
This type of study is important because it provides more complete information about a medication. While initial trials show if a drug works, extension studies help us understand its impact on people's lives for longer. This helps ensure that treatments for MS are as effective and as safe as possible for everyone.
Key takeaways
- This study is for people with MS who have already received ocrelizumab in a previous trial.
- It aims to check the long-term effectiveness and safety of ocrelizumab.
- Researchers will monitor disability, relapses, and other signs of MS activity.
- You'll receive regular health checks and the study medication.
- It helps gather more complete information about MS treatment.
Who may be eligible?
To be part of this study, you must have MS and have previously participated in an official F. Hoffmann-La Roche study where you received ocrelizumab. This means the study is specifically for people who are already familiar with the medication and have been treated with it before through a research program.
You must be at least 18 years old to join. There isn't an upper age limit mentioned, meaning older adults might also be able to participate if they meet the other requirements. The study is open to both men and women.
It's important to remember that these are just some of the main requirements. A doctor or nurse involved with the study would need to check your full medical history to confirm if you are suitable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have Multiple Sclerosis (MS).
- I have previously taken ocrelizumab in a F. Hoffmann-La Roche sponsored clinical trial.
- I am 18 years old or older.
- I am comfortable attending regular study visits and assessments.
What does participation involve?
If you join this study, you will continue to receive the study medication, Ocrevus (ocrelizumab), which is given as an infusion into a vein. Before receiving Ocrevus, you might be given other medications like methylprednisolone (a steroid), paracetamol, and diphenhydramine (an antihistamine). These are given to help reduce the chance of any reactions to the main study drug.
Throughout the study, you will have regular visits where doctors and nurses will check your health. They will perform examinations and tests to see how your MS is progressing. This includes checking your walking, hand movements, and overall disability. They will also ask you about any symptoms you might be experiencing. The total duration of your participation will depend on the study's protocol, but as an extension study, it's designed to follow you for a longer period of time.
Potential risks and benefits
Locations (14)
- —UnverifiedHungary
- —UnverifiedNorway
- —UnverifiedCroatia
- —UnverifiedDenmark
- —UnverifiedSlovakia
- —UnverifiedBelgium
- —UnverifiedNetherlands
- —UnverifiedSweden
- —UnverifiedItaly
- —UnverifiedPortugal
- —UnverifiedSlovenia
- —UnverifiedFrance
Common questions
What is ocrelizumab?
Ocrelizumab (also known by its brand name Ocrevus) is a medicine used to treat multiple sclerosis (MS). It works by targeting specific immune cells.
Why is this study only for people who have already taken ocrelizumab?
This is an 'extension study,' meaning it follows up on people who have already received the medication in an earlier study. This helps researchers understand its long-term effects.
What does 'disease progression' mean in MS?
Disease progression refers to how MS symptoms may get worse over time, potentially leading to increased disability.
Will I get medications other than ocrelizumab?
Yes, you might be given other medications such as a steroid (methylprednisolone), paracetamol, and an antihistamine (diphenhydramine) before your ocrelizumab infusion to help prevent reactions.
How long will I be in the study?
As an extension study, it's designed to follow you for a longer period to gather more long-term information. Your study doctor can give you more specific details.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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