A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
This research study is testing a higher dose of a medicine called ocrelizumab for adults who have primary progressive multiple sclerosis (PPMS). This type of MS gets steadily worse over time. The study aims to find out if this higher dose is more effective at slowing down the disease and if it's safe compared to the dose currently approved. Participants will be given either the new high dose or the standard dose through a drip every 24 weeks. We'll be looking carefully at how the medicine works, any side effects, and how it moves through the body over several years. This could potentially offer a new treatment option for people living with PPMS.
At a glance
What is this study about?
This study is for people living with primary progressive multiple sclerosis, often called PPMS. This is a type of MS where symptoms gradually get worse over time, rather than coming and going in attacks. The goal of this research is to see if a new, higher dose of a medicine called ocrelizumab can help people with PPMS more effectively than the dose currently available.
Ocrelizumab is already an approved treatment for MS. In this study, some participants will receive the approved dose, while others will receive a higher dose. Neither you nor your study doctor will know which dose you are getting – this is called a 'double-blind' study and helps ensure the results are as fair and unbiased as possible. The medicine will be given to you through a drip into your arm every 24 weeks (that's about every six months).
The researchers will closely watch how the medicine affects your MS, whether it helps to slow down the disease, and if any side effects occur. They will also look at how the medicine works in your body. The results of this study could help doctors understand if a different dose of ocrelizumab could be a better option for people with PPMS in the future.
Key takeaways
- This study is for adults with primary progressive MS (PPMS).
- It's testing if a higher dose of ocrelizumab is safe and works better than the standard dose.
- Participation involves regular IV infusions and clinic visits over several years.
- You won't know if you're getting the standard or higher dose in the main part of the study.
- Potential benefits include contributing to MS research; potential risks include medication side effects.
Who may be eligible?
To join this study, you must be an adult between 18 and 55 years old and have been diagnosed with primary progressive multiple sclerosis (PPMS). Your doctors will need to review your medical history and imaging scans, like MRI, to confirm your diagnosis and ensure your MS fits the study's requirements. You also need to be generally stable in your health and any MS treatments you're already taking.
There are also some important things that would prevent you from joining. For example, if you have other types of MS like relapsing-remitting MS or secondary progressive MS, you would not be able to participate. Also, if you have any active infections, a history of certain serious brain conditions, or past cancers, this study might not be right for you. Your study doctor will discuss all these details with you.
If you're a woman who could become pregnant, you'll need to agree to use effective birth control throughout the study. Women who are past menopause or have had certain surgeries would not need to use birth control.
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 between 18 and 55 years old?
- Do you have a diagnosis of primary progressive MS (PPMS)?
- Are you generally stable in your health and any current MS treatments?
- Have you had an MRI scan showing changes consistent with MS?
- Are you able to use reliable birth control if you could get pregnant?
What does participation involve?
If you decide to join this study, you'll be involved for quite a long time. You'll receive the study medicine, either the approved dose of ocrelizumab or the higher dose, through an intravenous (IV) drip every 24 weeks. You'll have regular visits to the study clinic for check-ups, where doctors will monitor your MS symptoms, take blood tests, and perform physical examinations. You'll also likely have MRI scans to see how your brain is responding to the treatment.
The main part of the study where you receive the treatment will last for at least 120 weeks, which is about two and a half years. After this, if the initial results are positive, there might be an option to continue receiving the higher dose in an 'open-label' phase, where everyone knows they are getting the higher dose. This extension would last for about 96 weeks (almost two more years). Once treatment stops, you'll be followed for safety for another 48 weeks. Some people might have even longer follow-up to check their immune cells return to normal levels. Throughout all these stages, the total time you're involved could be several years.
Potential risks and benefits
Locations (149)
- Alabama Neurology AssociatesVerified postcodeHomewood, United States
- 21st Century NeurologyVerified postcodePhoenix, United States
- University of California IrvineVerified postcodeIrvine, United States
- Stanford University Medical CenterVerified postcodeStanford, United States
- University of Colorado DenverVerified postcodeAurora, United States
- Advanced Neurosciences Research LLCVerified postcodeFort Collins, United States
- MS and Neuromuscular Center of ExcellenceVerified postcodeClearwater, United States
- University of South FloridaVerified postcodeTampa, United States
- Baptist Health LexingtonVerified postcodeNicholasville, United States
- International Neurorehabilitation InstituteVerified postcodeLutherville, United States
- Massachusetts General Hospital.Verified postcodeBoston, United States
- University of Massachusetts Medical SchoolVerified postcodeWorcester, United States
Common questions
What is primary progressive multiple sclerosis (PPMS)?
PPMS is a type of multiple sclerosis where your symptoms gradually worsen over time, without clear attacks or remissions.
What is ocrelizumab?
Ocrelizumab is a medicine used to treat certain types of MS. It works by targeting specific immune cells (B-cells) that are thought to be involved in MS.
Why are they testing a higher dose?
Researchers want to see if a higher dose of ocrelizumab might be more effective at slowing down PPMS compared to the dose currently approved.
Will I know if I'm getting the higher dose?
No, in the main part of the study neither you nor your doctor will know which dose you are receiving. This is called a 'double-blind' study.
How often will I need to visit the clinic?
You will need to visit the clinic for treatments every 24 weeks (about every six months), plus additional visits for check-ups and tests.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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