A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis
This study is investigating a drug called ocrelizumab for individuals living with progressive multiple sclerosis (PMS). Researchers want to understand better how effective ocrelizumab is at managing PMS and to check for any side effects. All participants will receive ocrelizumab, and the study doesn't compare it to another drug or a placebo. Doctors will carefully monitor participants' health and disability over time to see how the treatment affects them. This is an important step in learning more about how to help people with PMS, by studying a treatment in a real-world setting, and helping researchers understand its benefits and risks.
At a glance
What is this study about?
This study is about a medicine called ocrelizumab, which is being investigated for people with a type of multiple sclerosis called progressive multiple sclerosis, or PMS. PMS is a form of MS where symptoms gradually worsen over time, rather than coming in attacks or relapses. The main goal of this study is to see how well ocrelizumab works for people with PMS and if it's safe to use.
In this study, everyone taking part will receive ocrelizumab. This means there isn't a group that receives a different treatment or a dummy pill (placebo). This type of study helps doctors understand the real-world effects of the medication when given to a specific group of patients.
By carefully watching the participants and how their condition changes, researchers hope to gather important information. This will help them learn more about how ocrelizumab might help people manage their progressive MS symptoms and improve their quality of life. This research is a step forward in finding better ways to treat PMS.
Key takeaways
- The study is for people with progressive multiple sclerosis (PMS).
- All participants will receive the study medicine, ocrelizumab.
- It aims to check how well ocrelizumab works and if it's safe.
- You need to be aged 18-65 and able to use a smartphone.
- Careful monitoring of your health will be part of the study.
Who may be eligible?
To join this study, you need to be an adult between 18 and 65 years old and have a clear diagnosis of progressive multiple sclerosis (PMS). Your disability level, as measured by a common scale called EDSS, should be 6.5 or less. You also need to have shown a worsening of your disability in the last two years, which wasn't clearly caused by a sudden MS relapse.
Other important points include being comfortable using a smartphone and connecting to Wi-Fi. If you're a woman who could become pregnant, you'll need to agree to use effective birth control throughout the study and for some time afterwards. Certain health conditions, like other neurological diseases, difficulty having an MRI scan, or active infections, would mean you couldn't take part. Also, if you are pregnant, breastfeeding, or need ongoing treatment with certain strong medications like steroids, you wouldn't be able to join.
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 65 years old?
- Have you been diagnosed with progressive multiple sclerosis (PMS)?
- Have your MS symptoms gradually worsened over the last two years, separate from any relapses?
- Are you comfortable using a smartphone and connecting it to Wi-Fi?
- Are you able to have an MRI scan?
What does participation involve?
This study will involve regular visits to the clinic where you'll receive the ocrelizumab medicine. During these visits, doctors and nurses will carry out various checks and tests, like blood tests and neurological exams, to monitor your health and how the treatment is affecting you. You'll also be asked to provide information about your symptoms and how you're feeling using a smartphone.
The total amount of time you'll be involved in the study will vary, but it's a long-term study designed to observe the effects of ocrelizumab over an extended period. The study will continue to gather information about your health and any effects of the medicine for some time after your last dose. The team will provide you with a detailed schedule of visits and what to expect at each appointment.
Potential risks and benefits
Locations (124)
- MS Center of CaliforniaVerified postcodeLaguna Hills, United States
- SC3 Research Group, IncVerified postcodePasadena, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Yale UniversityVerified postcodeNorth Haven, United States
- University of South FloridaVerified postcodeTampa, United States
- University of ChicagoVerified postcodeChicago, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- Dragonfly Research, LLCVerified postcodeWellesley, United States
- Wayne State University School of MedicineVerified postcodeDetroit, United States
- Washington University School of MedicineVerified postcodeSt Louis, United States
- The MS Center of Northeastern New YorkVerified postcodeLatham, United States
- University of CincinnatiVerified postcodeCincinnati, United States
Common questions
What is ocrelizumab?
Ocrelizumab is a medicine being studied to see how well it works for people with progressive multiple sclerosis.
Will I get a dummy pill?
No, everyone in this study will receive the active medicine, ocrelizumab.
What is progressive multiple sclerosis (PMS)?
PMS is a type of MS where symptoms gradually get worse over time, rather than having clear attacks or relapses.
How long will the study last?
The study involves long-term monitoring, so you would be involved for an extended period, with ongoing check-ups.
Do I need to use a smartphone for this study?
Yes, you need to be familiar with using a smartphone and connecting it to Wi-Fi to take part in this study.
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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