A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod.
This study is investigating a medicine called Kesimpta (ofatumumab) for people living with a type of multiple sclerosis (MS) called relapsing multiple sclerosis (RMS). It aims to understand how effective Kesimpta is in reducing MS relapses and what patients experience while taking it. This research is particularly interested in people who are switching to Kesimpta from other common MS treatments like fumarates or fingolimod. The study will also carefully check for any side effects and how well people can tolerate the medicine. It’s an open-label study, meaning both patients and their doctors will know they are receiving Kesimpta.
At a glance
What is this study about?
This study is a medical research project focused on a medicine called Kesimpta, which is used to treat relapsing multiple sclerosis (RMS). RMS is a condition where the immune system mistakenly attacks the protective covering of nerve cells, leading to symptoms that come and go, known as relapses.
The main goal of this study is to see how well Kesimpta works in preventing these relapses over a period of 96 weeks (about 1 year and 10 months). Researchers will be counting how many relapses people have each year. They are especially interested in Kesimpta for people who are currently using other MS medicines and are considering switching to Kesimpta, or have recently done so.
Beyond just counting relapses, the study will also look at how Kesimpta affects patients' everyday lives. This includes understanding their experiences and how they feel about the treatment. The research team will also be closely monitoring for any side effects or changes in health that might be linked to the medicine, to make sure it's as safe and well-tolerated as possible.
Key takeaways
- The study tests Kesimpta for relapsing multiple sclerosis (RMS).
- It checks how well Kesimpta reduces MS relapses and its safety.
- It's for people switching from other common MS medicines.
- The study lasts for 96 weeks (almost 2 years).
- Participation involves regular clinic visits and self-injections of Kesimpta.
Who may be eligible?
To join this study, people must be 18 years old or older. The study is open to both men and women.
Participants must have a type of multiple sclerosis called relapsing multiple sclerosis (RMS). This means they experience periods where their MS symptoms get worse, followed by periods of recovery.
Crucially, people taking part will be those who are either currently taking other approved MS medicines (like fumarate-based treatments or fingolimod) and are planning to switch to Kesimpta, or have recently switched.
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 relapsing multiple sclerosis (RMS)?
- Are you currently on, or recently switched from, fumarate-based MS treatments or fingolimod?
- Are you willing to receive Kesimpta injections?
What does participation involve?
If you decide to take part in this study, you would be treated with Kesimpta. This medicine is given as an injection directly under the skin, using a pre-filled pen. You would typically do this yourself or with help, after being shown how.
Over the course of 96 weeks (that's about 1 year and 10 months), you would have regular visits to the clinic. During these visits, the medical team would check your health, ask about any relapses you've had, and monitor for side effects. They would also take blood and urine samples and check your vital signs like blood pressure regularly. The aim is to see how well the medicine is working for you and if you're experiencing any issues.
Potential risks and benefits
Locations (8)
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedPortugal
- —UnverifiedSlovakia
- —UnverifiedGermany
- —UnverifiedSlovenia
- —UnverifiedSpain
- —UnverifiedLatvia
Common questions
What is relapsing multiple sclerosis (RMS)?
RMS is a form of MS where symptoms come in 'flare-ups' or 'relapses,' followed by periods of recovery.
What is Kesimpta?
Kesimpta is a medicine approved to treat relapsing multiple sclerosis that aims to reduce relapses and slow disease progression.
How is Kesimpta given?
Kesimpta is an injection given under the skin, usually with a special pen, which you can often do at home.
How long does the study last?
The study will observe participants for 96 weeks, which is about 1 year and 10 months.
What happens if I want to leave the study?
You are free to leave the study at any time, and your decision will not affect your regular medical care.
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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