Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

This research is looking at a higher dose of a treatment called ocrelizumab for adults who have relapsing multiple sclerosis (RMS). The study aims to find out if this higher dose works better and is still safe compared to the approved standard dose. Participants will receive the treatment through a drip (IV infusion) every 24 weeks. This is a "blinded" study, meaning neither the participants nor their doctors will know whether they are getting the higher dose or the standard dose. It's a key step in understanding how different doses of this medicine might help people with RMS. The study will last for a few years, with careful monitoring of health and disease progression.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

864

Start

26 Nov 2020

Estimated completion

31 Aug 2028

Multiple Sclerosis

What is this study about?

This research study is about a medicine called ocrelizumab, which is already approved for treating a type of multiple sclerosis (MS) called relapsing MS. Doctors and researchers want to see if giving a higher dose of this medicine works better than the standard dose that is currently used. They also want to make sure that the higher dose is still safe for people to take.

Participants in this study will receive the medicine through a drip into a vein (this is called an intravenous, or IV, infusion) every 24 weeks. The study is set up so that some people will get the standard dose and others will get the higher dose. Neither the participants nor their study doctors will know which dose they are receiving – this is known as a "double-blind" study. This helps to make sure the results are as fair and accurate as possible. By doing this, the researchers can properly compare the higher dose to the standard dose.

The main goal is to check if the higher dose is more effective at controlling MS symptoms and preventing relapses, while also keeping a close eye on any side effects or safety concerns. This type of study (called a Phase 3 study) is a very important step before a new dose or treatment can be considered for wider use. It helps us understand if changing the dose could offer better options for people living with relapsing MS.

Key takeaways

This study is comparing a higher dose of ocrelizumab against the standard dose for relapsing MS.
It aims to see if the higher dose is more effective and safe for adults aged 18-55.
You'll receive treatment via an IV drip every 24 weeks.
The study is 'double-blind,' meaning you won't know which dose you're getting initially.
Participation involves regular clinic visits, assessments, and can last several years.
You can withdraw from the study at any time without affecting your ongoing medical care.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 55 years old who has been diagnosed with relapsing multiple sclerosis (RMS). You should have had at least two MS relapses in the past two years, or one relapse in the last year, but no relapses in the 30 days right before joining. Your MS symptoms should also be stable for at least 30 days before starting the study, and your disability score (EDSS) should be between 0 and 5.5.

There are also some reasons why you might not be able to join. For example, if you have another type of MS called primary progressive MS, or if you have an active infection, a history of certain serious brain conditions like PML, or have had cancer in the last 10 years. You also can't have received a live vaccine recently or be unable to have an MRI scan.

Women who could become pregnant must agree to use effective contraception during the study. If you take medicines for your MS symptoms or have physiotherapy, you should be on a stable dose and not have started anything new in the four weeks before joining.

Quick self-check

Are you between 18 and 55 years old?
Do you have a diagnosis of relapsing multiple sclerosis (RMS)?
Have you had at least one MS relapse in the last year, or two in the last two years, but none in the last month?
Is your MS stable and are your MS symptoms not getting worse quickly?
Can you commit to regular clinic visits and treatments over several years?
Do you have no history of certain other serious health conditions like recent cancer or active infections?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be involved for quite a long time – at least two and a half years, and potentially longer. During the main part of the study (about 120 weeks, or just over two years), you'll receive the study medicine, ocrelizumab, as an intravenous (IV) drip every 24 weeks. You'll have regular visits to the clinic for check-ups, assessments, and to make sure everything is going well.

After this main treatment phase, if the results are positive, you might be able to continue with an optional extension phase for another 96 weeks (about 1 year and 10 months), where you would know you are receiving the higher dose. Even after treatment stops, your health and safety will be monitored for another 48 weeks (almost a year). For some participants, there might be an additional follow-up phase to monitor your immune cells (B-cells) until they return to their normal levels. Throughout the study, you'll have various tests, including MRI scans, to monitor your MS.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as gaining access to a higher dose of an MS treatment that might be more effective, and receiving close medical monitoring throughout the study. However, there are also potential risks; for instance, the higher dose might not work better, or it could lead to more side effects than the standard dose. Common side effects with ocrelizumab can include reactions during the infusion, and a slightly higher risk of infections. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (120)

North Central Neurology Associates
Cullman, United States
Alabama Neurology Associates
Homewood, United States
21st Century Neurology
Phoenix, United States
Profound Research, LLC
Carlsbad, United States
Stanford University Medical Center
Stanford, United States
Advanced Neurology of Colorado, LLC
Fort Collins, United States
Neurology Associates, PA
Maitland, United States
University of South Florida
Tampa, United States
American Health Network Institute, LLC
Avon, United States
University of Kansas Medical Center
Kansas City, United States
The NeuroMedical Clinic of Central Louisiana
Alexandria, United States
Maine Medical Center
Scarborough, United States

+108 more sites — see the official record for the full list.

Common questions

What is ocrelizumab?

Ocrelizumab is a medicine used to treat multiple sclerosis. It works by targeting specific immune cells (B-cells) that are involved in the disease.

What does 'double-blind' mean?

It means neither you nor your study doctor will know if you are receiving the standard dose or the higher dose of the medicine. This ensures the study results are fair.

How will I receive the medicine?

The medicine is given through a drip into a vein (intravenous infusion) once every 24 weeks, which is about every six months.

How long will I be in the study?

The main part of the study lasts about 2.5 years, with potential extensions and follow-up periods that could make it longer, depending on your participation.

Can I stop participating in the study if I want to?

Yes, absolutely. You can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.