Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting Multiple Sclerosis Patients Aged 55 and Over (TWINS : Therapies Withdrawal IN Relapsing Multiple Sclerosis)
Are you over 55 with stable relapsing-remitting multiple sclerosis (MS) and currently taking MS medication? This study wants to find out if it's safe for people like you to stop taking these medicines. MS treatments can have side effects and long-term costs, so researchers want to see if older patients with stable MS might benefit from stopping them without their MS getting worse. The study will compare two groups: one that continues their usual treatment and another that stops it. Researchers will monitor both groups for two years, checking for any changes in MS activity, their general well-being, and disability. This could help doctors understand the best care for older MS patients.
At a glance
What is this study about?
This study is for people aged 55 and over who have a type of MS called relapsing-remitting multiple sclerosis (RRMS) and whose condition has been stable for several years while taking treatment. RRMS causes flare-ups of symptoms followed by periods of improvement. The medicines used for RRMS (called disease-modifying therapies or DMTs) help to reduce these flare-ups and slow down the disease. While these treatments are good at controlling MS, they can sometimes cause side effects, including a higher risk of infections. This was particularly noticeable during the COVID-19 pandemic.
As people with MS get older, their immune system changes, and the risk of infections from these medications might outweigh the benefits. Also, for older patients whose MS has been stable for a long time, there's a question about whether continuing these treatments is still necessary. Some smaller studies have suggested that stopping treatment might not lead to more flare-ups in older, stable patients. This study wants to investigate this idea more thoroughly in a larger group of people.
The main goal of this study is to see if stopping your MS treatment is just as safe and effective as continuing it for people over 55 with stable RRMS. It will compare what happens to people who stop their medication versus those who carry on, looking at things like MS flare-ups, how well people feel, and any changes in their day-to-day abilities. The results could help doctors decide whether older patients with stable MS can safely stop their treatment, potentially reducing side effects and the burden of daily medication.
Key takeaways
- This study investigates stopping MS medication in stable patients over 55.
- It compares continuing treatment versus stopping it over two years.
- Researchers will check for MS activity, quality of life, and disability.
- Could help determine if older patients can safely reduce medication burden.
- Participation involves regular hospital visits, MRI scans, and questionnaires.
Who may be eligible?
To be part of this study, you need to be at least 55 years old and have a diagnosis of relapsing-remitting MS. Your first MS symptom or diagnosis must have been more than 5 years ago. It’s important that your MS has been stable for the past 5 years, meaning no flare-ups (relapses) and no significant changes in your disability or on your MRI scans.
You also need to have been on a specific type of MS medication, like interferon beta or glatiramer acetate, continuously for at least 5 years. You must be able to understand what the study involves and be willing to participate over two years. Your doctor will confirm if your MS diagnosis and stability meet the study criteria.
Some reasons why you might not be able to join include having primary or secondary progressive MS, or having previously taken stronger MS medications within a certain timeframe. You would also be excluded if you have any medical conditions or implants (like a pacemaker) that prevent you from having an MRI scan.
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 55 years old or older?
- Do you have relapsing-remitting MS?
- Has your MS been stable (no relapses, no major changes) for the past 5 years?
- Have you been on a 'moderate efficacy' MS treatment for at least 5 years?
- Are you able to have MRI scans?
What does participation involve?
If you decide to take part, you'll be randomly put into one of two groups: one group will stop their MS medication, and the other will continue taking it as usual. You won't get to choose which group you're in. The study will last for two years.
Over these two years, you will have five visits to the hospital or clinic: one at the very start, and then every six months (at 6, 12, 18, and 24 months). During these visits, you'll have an MRI scan to check for any changes in your brain, complete questionnaires about your quality of life, and have tests to assess your disability and overall health. There will also be a short phone call at three months. Your MS medication will either be stopped or continued as per your assigned group. Throughout the study, the research team will monitor you closely.
Potential risks and benefits
Locations (22)
- CHU de Bordeaux-Hôpital PellegrinVerified postcodeBordeaux, France
- CHU de Caen-Hôpital Côte de NacreVerified postcodeCaen, France
- CHU de Clermont-Ferrand-Hôpital Gabriel MontpiedVerified postcodeClermont-Ferrand, France
- Assistance Publique des Hôpitaux de Paris (APHP)-Hôpital Henri MondorVerified postcodeCréteil, France
- CHU de Dijon-Hôpital du BocageVerified postcodeDijon, France
- CH de GonesseVerified postcodeGonesse, France
- CHU de Grenoble AlpesVerified postcodeLa Tronche, France
- Groupement des Hôpitaux de l'Institut Catholique de Lille Hôpital Saint Vincent de PaulVerified postcodeLille, France
- CHU de Lille-Hôpital Roger SalengroVerified postcodeLille, France
- CHU de Limoges-Hôpital DupuytrenVerified postcodeLimoges, France
- Assistance Publique des Hôpitaux de Marseille (APHM)-Hôpital La Timone AdultesVerified postcodeMarseille, France
- CHU de Montpellier-Hôpital G. De ChauliacVerified postcodeMontpellier, France
Common questions
What is relapsing-remitting MS (RRMS)?
RRMS is a type of MS where you have periods of new or worsening symptoms (flare-ups) followed by periods where symptoms improve or disappear.
What are Disease-Modifying Therapies (DMTs)?
These are medications for MS that aim to reduce flare-ups and slow down the disease by affecting your immune system.
Why is this study focused on people over 55?
As people with MS get older, their immune system changes, and doctors want to see if the benefits of continuing certain medications still outweigh potential risks like infections.
Will I know which group I’m in?
Yes, this is an 'open-label' study, meaning both you and the study team will know whether you are continuing or stopping your medication.
What does a 'stable disease' mean in this study?
It means you haven't had any MS flare-ups, major changes in your disability, or new spots on your MRI scans for at least 5 years.
How to find out more
Sarah HUSTACHE
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.