Active not recruitingOBSERVATIONAL

OFSEP High Definition Cohort

This important study, called OFSEP High Definition Cohort, is looking into Multiple Sclerosis (MS). Its main goal is to understand why MS can get worse for some people and to develop ways to predict how the disease might change over time, helping doctors and patients make better decisions. Researchers will be looking at many different factors, from personal characteristics and quality of life to the impact of various treatments in real-life situations. By combining all this information, they hope to create handy tools to help identify specific groups of patients and guide choices about starting, continuing, or adjusting their care. This research uses a large, existing French MS database to gather detailed, ongoing information from many people with MS.

At a glance

Status

Active not recruiting

Sponsor

EDMUS Foundation

Enrolment target

2,842

Start

10 Jul 2018

Estimated completion

01 Dec 2026

Multiple Sclerosis

What is this study about?

Multiple Sclerosis (MS) is a complex condition, and while there's no cure yet, a big challenge for doctors and people living with MS is understanding why the disease progresses differently for everyone. This study, called the OFSEP High Definition Cohort, aims to shed light on this crucial question. It's designed to figure out what factors influence how MS changes over time for individuals.

The main purpose of this study is to identify what causes someone's MS to get worse and to develop new tools that can help predict how the disease might progress. This means looking at a wide range of things, like your personal health details, how doctors are currently managing MS, and how these factors might have influenced your condition since you were first diagnosed. The researchers want to understand how different treatments work in real life and whether certain characteristics of a person might impact their journey with MS. Ultimately, all this information will help create tools that are focused on individual patients.

Imagine having a clearer picture of what might happen with your MS, enabling you and your doctor to make more informed decisions about your care. That's the ultimate goal of OFSEP-HD. By gathering detailed information from a large number of people with MS in France, the study hopes to improve our understanding of the disease, leading to better ways to predict its course and more personalised treatment plans. This could mean knowing when to start, continue, or change treatments to best suit your needs.

Key takeaways

This study aims to improve understanding of MS progression and help patients.
It uses a large French MS database to collect real-life information about MS.
No new treatments or medications are involved, it's about observation.
Participation involves sharing health information and completing questionnaires.
The goal is to create better predictive tools for personalised MS care.

Who may be eligible?

To be part of this study, you need to have a diagnosis of Multiple Sclerosis (MS) and be receiving care at one of the specialist MS centres in France. You could be someone newly diagnosed with MS after the study began, or someone who was diagnosed earlier but has been regularly seen at one of these specialist centres.

There are also some requirements about your physical ability. Your disability level, measured by something called the EDSS scale, needs to be 7.0 or less at the time you join the study. This means you shouldn't be permanently using a wheelchair when you start.

There are a couple of reasons why someone might not be able to join. If you're pregnant at the time you're being considered for the study, you wouldn't be able to participate. Also, if you're unable to answer questionnaires, for example, due to a communication difficulty, then this study might not be suitable for you.

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.

Do I have a diagnosis of Multiple Sclerosis?
Am I followed by a specialist MS clinic in France?
Was I newly diagnosed with MS after the study began, or have I had regular care at an MS clinic if diagnosed earlier?
Is my current disability level (measured by EDSS) 7.0 or less (meaning I'm not permanently in a wheelchair)?
Am I able to answer questionnaires?
Am I currently not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will mainly involve sharing information about your health and your MS journey. This study uses an existing infrastructure, the French MS registry, to collect high-definition and sequential data. This means that information about your MS diagnosis, your symptoms, your treatments, and your quality of life will be gathered progressively over time. You will be asked to complete questionnaires, and your doctors will record details about your clinical visits and how your MS is progressing. You won't be given any new or experimental medications as part of this study; it's focused on observing how MS evolves and how existing treatments are used in real life. The duration of your participation will depend on how long you continue to be followed at your specialist MS centre, as the study aims to track changes over a long period.

Potential risks and benefits

Taking part in this study won't involve any new medical treatments or procedures, so there are no direct physical risks. You might find some benefit in knowing that the information you provide is contributing to a better understanding of MS, which could eventually lead to improved care for others. The main commitment is sharing your health information and completing questionnaires, which might take some of your time. You are completely free to decide if you want to take part, and if you do join, you can withdraw at any time without giving a reason, and this will not affect your usual medical care.

Locations (25)

CHU de Besançon
Verified postcode
Besançon, France
CHU de Bordeaux
Verified postcode
Bordeaux, France
CHU de Caen
Verified postcode
Caen, France
CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France
CHU de Créteil
Verified postcode
Créteil, France
CHU de Dijon
Verified postcode
Dijon, France
CHU de Grenoble
Verified postcode
Grenoble, France
CHU de Lille
Verified postcode
Lille, France
CHU de Limoges
Verified postcode
Limoges, France
CHU de Lyon
Verified postcode
Lyon, France
CHU de Montpellier
Verified postcode
Montpellier, France
CHU de Nancy
Verified postcode
Nancy, France

Common questions

What is the main goal of this study?

To understand what causes MS to get worse and to create tools to predict how the disease might progress for individuals.

Do I have to take new medicine if I join?

No, this study doesn't involve any new medications. It observes how MS progresses and how existing treatments are used.

Who can join this study?

People with MS who are seen at a specialist MS clinic in France, and whose disability level is not too high (not permanently in a wheelchair).

Will my information be kept private?

Yes, all data collected for the OFSEP registry is managed with strict quality and privacy standards.

What if I change my mind after joining?

You can withdraw from the study at any time without it affecting your medical care.