All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis

This important study, called ChariotMS, is looking at Cladribine (also known as Mavenclad) for people living with advanced Multiple Sclerosis (MS). While Cladribine is currently used for another type of MS, we're exploring if it can help those with more advanced forms of the condition where disability has progressed. The aim is to check if this medication is safe and effective in slowing down the worsening of MS and improving daily life for patients. We're carefully comparing it to a dummy treatment (placebo) to understand its true effects. This research could open up important new treatment options for many people.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
Queen Mary University of London
Enrolment target
204
Start
25 Jun 2021
Estimated completion
31 Dec 2027

What is this study about?

Multiple Sclerosis (MS) is a long-term condition that affects your brain and spinal cord. For many people with MS, the disease can gradually get worse over time, leading to increasing difficulties with movement and daily activities. At the moment, there aren't many treatments specifically for more advanced stages of MS that focus on slowing down this worsening.

This study, called ChariotMS, is investigating if a drug called Cladribine (you might hear it called Mavenclad) could be helpful for people with advanced MS. Cladribine works by reducing certain immune cells that are thought to play a role in MS. It's already approved for another type of MS, but we need to find out if it's safe, effective, and good value for money for people whose MS has progressed further.

We really hope this study will give us important answers and potentially lead to new ways to help people with advanced MS live fuller, more independent lives. We'll be looking carefully at whether it can slow down the physical changes caused by MS, make daily tasks easier, and generally improve how people feel.

Key takeaways

  • Tests Cladribine (Mavenclad) for advanced MS.
  • Aims to slow MS progression and improve quality of life.
  • Compares the drug to a dummy treatment (placebo).
  • Involves short courses of tablets over two years.
  • Could lead to new treatments for advanced MS.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) with advanced MS where you need some help with walking, possibly using a stick for short distances, or even a wheelchair for longer distances. We'd also check that your arm and hand movements meet certain levels, as this is important for how we measure the drug's effects. You would need to have had regular health screenings recommended by the NHS, such as for bowel or breast cancer.

However, there are reasons why you might not be able to join. For example, if you have severe kidney or liver problems, uncontrolled diabetes or high blood pressure, or a history of heart attack or stroke, you probably wouldn't be suitable. If you are pregnant, planning to become pregnant, or breastfeeding, you also couldn't take part. We can make exceptions for some past serious illnesses like cancer if your treatment team confirms you are clear.

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.

  1. Are you 18 years old or older with MS?
  2. Do you have advanced MS with walking difficulties?
  3. Are you able to use at least one hand/arm reasonably well?
  4. Do you meet NHS cancer screening guidelines?
  5. Are you not pregnant, breastfeeding, or planning a pregnancy soon?
  6. Do you have other health conditions that are well-controlled?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the study drug (Cladribine) or a placebo (a dummy treatment, like a sugar pill). You won't know which one you're getting, and neither will your study doctor. The treatment will be given in short courses over two years. This means you'll take tablets for about 8-10 days each year.

You'll have regular visits to the study clinic for check-ups, blood tests, and to assess your MS symptoms and abilities, like how you use your hands. Researchers will also be looking at the cost-effectiveness of the treatment. These visits will help us understand how the treatment is working and monitor your health carefully. The total study duration will be several years, including follow-up after your treatment courses.

Potential risks and benefits

Taking part in this study might offer the potential benefit of receiving a treatment that could slow down the progression of your MS and improve your quality of life, which is not currently available for advanced MS. However, like all medications, Cladribine has potential side effects, which your study doctor will discuss with you in detail. There's also a chance you might receive the placebo and not the active drug. Your safety and well-being are our top priority, and you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Queens University Belfast (Belfast Health and Social Care Trust)
    Verified postcode
    Belfast, United Kingdom
  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
    Verified postcode
    Birmingham, United Kingdom
  • Cardiff University Hospital
    Verified postcode
    Cardiff, United Kingdom
  • University Hospitals of Coventry and Warwickshire NHS Trust
    Verified postcode
    Coventry, United Kingdom
  • Anne Rowling Clinic, University of Edinburgh
    Verified postcode
    Edinburgh, United Kingdom
  • Queen Elizabeth University Hospital Glasgow
    Verified postcode
    Glasgow, United Kingdom
  • University Hospital Hairmyres, NHS Lanarkshire
    Verified postcode
    Glasgow, United Kingdom
  • Leeds Teaching Hospitals NHS Trust
    Verified postcode
    Leeds, United Kingdom
  • Walton Centre NHS Trust
    Verified postcode
    Liverpool, United Kingdom
  • Royal London Hospital
    Verified postcode
    London, United Kingdom
  • Royal Free London NHS Foundation Trust
    Verified postcode
    London, United Kingdom
  • Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust)
    Verified postcode
    London, United Kingdom

Common questions

What is Cladribine?

Cladribine is a medication that works by reducing certain immune cells in your body. It's used for some types of MS and is being tested here for advanced MS.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps us fairly compare the effects of the active drug.

How long will the study last?

The main treatment period involves taking tablets over two years, with follow-up appointments extending beyond that to monitor your health.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your study doctor will know whether you are receiving Cladribine or the placebo until the study is over. This is called 'double-blind'.

Can I stop participating if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your standard 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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