ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS
The ELIOS study is investigating new ways to monitor relapsing-remitting multiple sclerosis (RRMS) in people already receiving a medication called ofatumumab. Researchers will use a special eye-tracking tool, not yet fully approved, to precisely measure eye movements. The goal is to see if these eye movements can give early clues about how the disease is changing and how well the treatment is working. This is a "real-world" study, meaning it looks at patients during their regular care, not in a highly controlled lab setting. It's hoped that this research could lead to better ways of tracking MS and understanding treatment effects in the future.
At a glance
What is this study about?
This study, called ELIOS, is focusing on people in Canada who have a type of multiple sclerosis (MS) called relapsing-remitting MS (RRMS). This is the most common form of MS, where people experience periods of new symptoms or worsening old symptoms (relapses), followed by periods of recovery. The main goal of ELIOS is to explore whether a new technology can help doctors understand how MS is changing over time and how well treatments are working.
The study is particularly interested in something called "investigational Eye Movement Biomarkers" (EMBs). These are basically very precise measurements of how a person's eyes move. The researchers will use a special device, an Eye Tracking Neurological Assessment (ETNA-ProgMS) tool, to measure these movements. Think of it like a very advanced eye exam that can pick up tiny changes that might not be obvious otherwise. While this technology isn't fully approved for general use yet, this study is testing its potential.
ELIOS is looking at patients who are starting treatment with a medication called ofatumumab, which is used for RRMS. The study wants to see if the eye-tracking measurements can show changes linked to the disease or how the treatment is affecting it. This kind of research is important because it could lead to new, easier ways for doctors to keep an eye on MS and make sure people are getting the best care possible.
Key takeaways
- This study explores using eye movements to track MS changes.
- It's for Canadian adults with active relapsing-remitting MS starting ofatumumab.
- The eye-tracking technology is still being developed and tested.
- Participation involves eye tests and blood samples over time.
- It aims to improve how doctors monitor MS progression and treatment effects.
- Joining is voluntary, and you can stop at any time.
Who may be eligible?
To join the ELIOS study, you would need to be an adult in Canada, aged 18 to 99, and have been diagnosed with active relapsing-remitting MS. You should be about to start taking a new MS medication called ofatumumab, and the decision to prescribe this medication must have been made by your doctor before you consider joining the study.
You would also need to be able to provide blood samples and understand spoken or written Canadian English or French. Your vision should be good enough, with glasses or contacts if needed, to read instructions on a screen. Your doctor will also check that your physical disability hasn't been steadily getting worse over the last six months, outside of any relapses.
However, you cannot join if you have other types of MS, such as primary progressive MS, or if you have inactive secondary progressive MS. You also wouldn't be able to take part if you have any other health condition that would make it difficult or unsafe to participate in the study.
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 an adult aged 18 to 99?
- Do you have active relapsing-remitting MS?
- Have you recently been prescribed ofatumumab, but haven't started it yet?
- Can you provide blood samples?
- Can you understand English or French spoken in Canada?
- Is your vision good enough (with glasses if needed) to read computer instructions?
What does participation involve?
If you decide to take part in the ELIOS study, you'll be joining a group of patients who are already starting treatment with ofatumumab. You'll have regular visits where researchers will use a special eye-tracking device to measure your eye movements. This device has not yet been approved by health authorities, so this is part of testing how well it works.
Throughout the study, you'll also be asked to provide blood samples. The study will follow your progress and how your MS is changing while you are on your regular treatment. The overall aim is to gather information over time to see if the eye-tracking measurements can help understand how the disease is progressing. The total duration of your involvement in the study would depend on the study plan, but it will involve ongoing assessments and follow-up.
Potential risks and benefits
Locations (14)
- Novartis Investigative SiteVerified postcodeCalgary, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeCalgary, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeEdmonton, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeBurnaby, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeVancouver, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeSt. John's, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeHalifax, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeHalifax, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeOttawa, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeMontreal, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeMontreal, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeMontreal, Canada· Recruiting
Common questions
What is 'active RRMS'?
Active RRMS means you have relapsing-remitting MS, and you've recently had new or worsening symptoms or changes seen on an MRI scan.
What is ofatumumab?
Ofatumumab is a medication used to treat relapsing forms of multiple sclerosis in adults.
What does 'investigational' mean for the eye-tracking tool?
'Investigational' means the eye-tracking tool is still being tested and doesn't yet have full approval from health authorities for regular medical use.
Will my regular MS treatment change if I join?
No, this study is observing patients who are already prescribed ofatumumab as part of their routine care. The study itself won't change your prescribed treatment.
Do I have to pay to be part of the study?
No, you should not have to pay anything to participate in a clinical study. All study-related assessments will be covered.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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