A Study to Investigate Single Ascending Doses of Ocrelizumab for Safety and Side Effects, How The Body Handles It Over A Period of Time, How The Body Notices and Reacts To It, And Its Effect On The Body When Given As A Subcutaneous Injection In Patients With Multiple Sclerosis
This early-stage study is looking at a medicine called ocrelizumab, which is being tested as a new injection under the skin for people with Multiple Sclerosis (MS). The main goals are to find out if different amounts (doses) of the medicine are safe and what side effects they might cause. Researchers also want to understand how the body deals with the medicine over time, how the body's defence system reacts to it, and what effects it has on the body. This is a very initial study, focusing on understanding the new injection before it can be tested in larger groups of people.
At a glance
What is this study about?
This study is about a medicine called ocrelizumab, which is already used for Multiple Sclerosis (MS) but usually given in a different way. Here, doctors are trying out a new way to give it: as an injection under the skin, similar to how many common jabs are given. Think of it like trying out a new flavour of a food you already know – you want to see if you like it and if it works just as well, or even better, in its new form.
The main reasons for doing this study are to check if this new injection method is safe and what side effects people might get. They also want to understand how the body uses and gets rid of the medicine over time. This is important to make sure the right amount is given. Researchers will also look at how your immune system (your body's natural defence) reacts to the medicine and what direct effects the medicine has inside your body.
This kind of study is called a 'Phase I' study, which means it's one of the very first times this specific new injection method for ocrelizumab is being tested in people. It’s done to gather basic but vital information about safety and how the medicine behaves in the body before moving on to larger studies. This helps ensure that any future trials are as safe and effective as possible.
Key takeaways
- This study is testing a new injectable form of a medicine for MS called ocrelizumab.
- It's an early-stage study focusing on safety and how the body handles the medicine.
- You would receive regular injections and attend study visits for health checks.
- Participation involves commitments over time, including follow-up appointments.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is looking for adults aged 18 and over, with no upper age limit, who have been diagnosed with Multiple Sclerosis (MS). Both men and women are welcome to take part in this research.
To be considered for this study, you would need to meet certain health requirements related to your MS and overall health. The specific details would be discussed fully by the study team, who would check if the study is a good fit for you and if it would be safe for you to participate.
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 years old or older?
- Do you have a diagnosis of Multiple Sclerosis (MS)?
- Are you able to attend regular clinic appointments?
- Are you able to give blood samples?
- Are you comfortable with receiving injections under the skin?
What does participation involve?
If you decide to take part in this study, you will be given the study medicine, ocrelizumab, as an injection under your skin. You will need to attend several visits to the study clinic or hospital. During these visits, the study team will carry out various assessments. These might include blood tests, health checks, and questions about how you are feeling and any effects you notice. They will also look at how your body is reacting to the medicine.
You will have regular follow-up appointments to monitor your health and how the medicine is working. The total time you would be involved in the study would depend on how many doses you receive and the follow-up period needed to gather all the necessary information, but it would involve a commitment over a period of time.
Potential risks and benefits
Locations (5)
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is ocrelizumab?
Ocrelizumab is a medicine already used to treat Multiple Sclerosis. This study is testing a new way to give it as an injection under the skin.
Why is this study necessary?
This study helps researchers find out if giving ocrelizumab as an injection under the skin is safe, how the body handles it, and what effects it has before it can be used more widely.
What does 'Phase I' mean?
Phase I means it's a very early study. It's usually the first time a new medicine or a new way of giving a medicine is tested in people after animal studies.
Will I know if I'm getting the real medicine?
In some studies, people might get a dummy treatment (placebo), but in this specific type of study, everyone usually receives the active medicine, just at different doses.
Do I have to pay to join the study?
No, you do not have to pay to join a clinical trial. All study-related medication and assessments are provided at no cost to you.
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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