A study to find out the best length of time between ocrelizumab doses for patients with relapsing remitting multiple sclerosis using a trial design with multiple groups and multiple stages
This important study is for adults living with relapsing-remitting multiple sclerosis (RRMS) who are already taking a medicine called ocrelizumab (also known as Ocrevus). Researchers want to find the best timing for infusions of this medicine. Currently, it's often given every six months. The trial aims to see if changing how often patients receive their dose might be more effective or better for them. By carefully testing different schedules in a large group of people, scientists hope to discover the ideal way to give ocrelizumab to help manage RRMS symptoms and improve daily life for patients. It's about finding the most beneficial treatment plan for individuals.
At a glance
What is this study about?
This study is designed for adults who have a type of multiple sclerosis (MS) called relapsing-remitting MS (RRMS). RRMS is a long-term condition that affects your brain and spinal cord, causing episodes of new or worsening symptoms (called relapses) followed by times when you feel better (called remission). The study focuses on a medicine called ocrelizumab, which is used to treat RRMS.
For many medicines, finding the right amount to give (the dose) and how often to give it (the frequency) is very important. With ocrelizumab, it's typically given as an infusion every six months. This study aims to explore if there's a better or more effective way to schedule these treatments. Researchers want to find the ideal length of time between doses to help people with RRMS manage their condition as well as possible, possibly with fewer side effects or better symptom control.
By carefully comparing different dosing schedules, the study hopes to gather valuable information that could lead to new recommendations for how ocrelizumab is given in the future. This could help doctors and patients make informed decisions about treatment plans and potentially improve the lives of many people living with RRMS.
Key takeaways
- This study is for adults with relapsing-remitting MS already on ocrelizumab.
- It aims to find the best schedule for ocrelizumab doses.
- Participants will have regular medical checks and MRI scans.
- You must not have had a recent MS relapse or new MRI changes.
- Your participation could help improve future MS treatment for many.
Who may be eligible?
This study is looking for adults aged 18 or older who have been diagnosed with relapsing-remitting MS (RRMS) and are currently taking ocrelizumab. You'll need to have been on ocrelizumab for at least two years (four doses given six months apart) following UK guidelines.
Your level of disability from MS, as measured by a specific scale (called EDSS), needs to be within a certain range – from no disability up to someone who might need a walking aid for longer distances but can still walk. You also need to be willing to continue taking ocrelizumab and agree to have regular MRI scans.
There are some reasons why you might not be able to join. For example, if you've had an MS relapse or new changes on your brain scan (MRI) in the past year, or if you're taking other medicines that affect your immune system. You also wouldn't be able to join if you're pregnant, planning to become pregnant, or if there's any reason you can't have regular MRI scans.
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.
- Are you 18 or older?
- Do you have relapsing-remitting MS?
- Are you currently taking ocrelizumab (Ocrevus) and have you been for at least two years?
- Are you willing and able to have regular MRI scans?
- Are you not pregnant or planning to become so during the study?
What does participation involve?
If you join this study, you'll continue to receive ocrelizumab, but the timing of your doses might be different from the standard every six months. You'll have regular appointments at the clinic, which will include medical checks, blood tests, and important brain scans (MRIs) to see how your MS is responding to the treatment. These scans are a crucial part of the study.
The study will compare different groups, with each group receiving ocrelizumab on a different schedule. You won't know which schedule you're on, but your clinical team will be closely monitoring you. The total duration of your participation in the study will be determined by the researchers, but clinical trials usually involve a commitment of several years, including follow-up assessments.
Potential risks and benefits
Locations (2)
- UCLH National Hospital for Neurology and NeurosurgeryCity onlyLondon, England
- University Hospital Coventry and WarwickshireCity onlyCoventry, England
Common questions
What is relapsing-remitting multiple sclerosis (RRMS)?
RRMS is a type of MS where you have episodes of new or worsening symptoms (relapses) followed by periods where your symptoms get better (remission).
What is ocrelizumab (Ocrevus)?
Ocrelizumab is a medicine used to treat relapsing-remitting MS. It is given as an infusion into a vein.
Why is this study looking at different dosing schedules?
Researchers want to find the best possible timing between ocrelizumab doses to help manage MS most effectively for patients.
Will I know which dosing schedule I'm on?
No, this is a 'blinded' study, meaning you won't know if you're on a different schedule. This helps ensure the results are fair.
What if I change my mind after joining?
You are free to leave the study at any time, for any reason, and your medical care will not be affected.
How to find out more
- REFINE-MS Team
Always speak to your GP or specialist before deciding to take part in a study.
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