ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis
Multiple sclerosis (MS) affects more than 120,000 people in the UK. Over time, many people develop advanced MS, which can severely limit walking and daily activities. Most existing MS drugs only target early stages of the condition, leaving very few options for people with greater disability. The ChariotMS study is investigating a tablet medication called cladribine (MAVENCLAD®). Cladribine works by lowering certain immune cells that attack nerves. Researchers want to find out whether this treatment can slow down or stop the loss of hand and arm function in people with advanced MS. Participants take short courses of tablets over two years. Because this is a randomised trial, half of the participants receive cladribine and half receive a dummy pill (placebo). This helps doctors clearly see if the medicine works and is safe for people with advanced MS.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Multiple sclerosis is a long-term condition where the body's immune system mistakenly attacks the protective layer around nerves in the brain and spinal cord. Over time, this damage can lead to advanced MS, where walking becomes very difficult or impossible. While there are many treatments available for earlier stages of MS, there are currently almost no approved disease-modifying treatments for people who rely heavily on wheelchairs.
Even when walking is lost, being able to use your hands and arms is vital for everyday life. Simple tasks like eating, typing, brushing your teeth, or operating a wheelchair depend on upper body strength and coordination. The ChariotMS trial focuses specifically on protecting this hand and arm function, rather than focusing only on walking ability.
The medicine being tested is cladribine, which is already used for earlier, relapsing forms of MS. It works by temporarily clearing away specific white blood cells that cause nerve inflammation. In this trial, doctors want to see if cladribine can protect nerves in people with advanced MS and prevent their hand strength from getting worse over time.
This is a UK-wide study comparing cladribine to a placebo (an identical tablet with no active medicine). Testing cladribine against a placebo is the safest and most reliable way to prove whether any changes are truly caused by the drug. If successful, this trial could open the door to the first treatment specifically aimed at preserving independence for people with advanced MS.
النقاط الرئيسية
- ChariotMS is testing cladribine tablets to see if they protect arm and hand function in people with advanced MS.
- This is one of the first clinical trials specifically designed for people with higher levels of MS disability.
- Participants take short courses of tablets over two years and are randomly assigned to either cladribine or a placebo.
- You must still have some hand movement to be able to take part in the study.
- Participation is entirely voluntary, and your safety is closely monitored throughout the trial.
من قد يكون مؤهلاً؟
This trial is open to adults aged 18 and older who have been diagnosed with advanced or progressive MS. Participants will generally have higher levels of mobility disability (such as needing a wheelchair to get around), but must still have enough use in at least one hand to complete a simple pegboard movement test within three minutes. Doctors also need to see that your arm or hand function has worsened over the past two years.
To be eligible, you must also be up to date with routine NHS cancer screenings that apply to you, such as cervical, breast, or bowel screening. You will need to weigh at least 40 kg (around 6 stone 4 lbs).
You will not be able to join if you have certain other health conditions, such as severe heart, kidney, or liver disease, uncontrolled diabetes, or a history of stroke. You cannot take part if you have an active long-term infection (such as tuberculosis, hepatitis, or HIV) or a current cancer. Pregnant and breastfeeding women cannot participate, and all participants who could start a pregnancy must agree to use reliable contraception during and after the study.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- I am aged 18 or older and have a confirmed diagnosis of MS.
- I have advanced MS and use a wheelchair for most or all of my mobility.
- I have noticed that my hand or arm function has gotten worse over the last two years.
- I still have enough control in at least one hand to pick up and move small objects.
- I am up to date with routine NHS cancer screening invitations.
- I do not have serious heart, liver, or kidney problems, or active serious infections.
ماذا يتضمن المشاركة؟
Taking part in ChariotMS lasts for about two years. If you join, you will be randomly placed into one of two groups: one group takes cladribine tablets, and the other takes matching placebo tablets. Neither you nor your doctor will know which group you are in during the trial.
The tablets are taken in short courses: a few days of pills at the start of year one, a few days a month later, and the same short schedule repeated in year two. Throughout the two years, you will attend regular hospital appointments. During these visits, the research team will check your health, take routine blood tests, and measure your arm and hand coordination using a simple peg test. Doctors will closely track any side effects or changes in your symptoms.
المخاطر والفوائد المحتملة
المواقع (22)
- Queens University Belfast (Belfast Health and Social Care Trust)الرمز البريدي المؤكدبلفاست، المملكة المتحدة
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birminghamالرمز البريدي المؤكدبرمنغهام، المملكة المتحدة
- Cardiff University Hospitalالرمز البريدي المؤكدكارديف، المملكة المتحدة
- University Hospitals of Coventry and Warwickshire NHS Trustالرمز البريدي المؤكدكوفنتري، المملكة المتحدة
- Anne Rowling Clinic, University of Edinburghالرمز البريدي المؤكدإدنبرة، المملكة المتحدة
- Queen Elizabeth University Hospital Glasgowالرمز البريدي المؤكدغلاسكو، المملكة المتحدة
- University Hospital Hairmyres, NHS Lanarkshireالرمز البريدي المؤكدغلاسكو، المملكة المتحدة
- مستشفيات ليدز التعليمية التابعة لخدمة الصحة الوطنيةالرمز البريدي المؤكدليدز، المملكة المتحدة
- Walton Centre NHS Trustالرمز البريدي المؤكدليفربول، المملكة المتحدة
- Royal London Hospitalالرمز البريدي المؤكدلندن، المملكة المتحدة
- مؤسسة رويال فري لندن التابعة لهيئة الخدمات الصحية الوطنيةالرمز البريدي المؤكدلندن، المملكة المتحدة
- Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust)الرمز البريدي المؤكدلندن، المملكة المتحدة
أسئلة شائعة
What is a placebo and why is it used?
A placebo is a dummy pill that looks and tastes just like the real medicine but contains no active ingredients. Comparing cladribine against a placebo helps researchers clearly see whether changes are truly caused by the medicine.
Will I know if I am getting the real drug or the placebo?
No. This is a 'double-blind' study, meaning neither you nor your study doctors will know which tablet you receive until the entire study is finished. This keeps the results completely fair and unbiased.
Why is this trial focusing on hand and arm movement?
Most previous MS trials focused on walking. For people who already use wheelchairs, keeping hand and arm function is crucial for feeding, washing, and staying independent. This trial is designed to protect those vital daily abilities.
How often do I need to take the tablets?
Cladribine is taken as short courses of pills. You take them for about 4 to 5 days, repeat this a month later, and then do the same schedule one year later. For the rest of the year, you do not take the trial pills.
هل يمكنني مغادرة الدراسة إذا غيرت رأيي؟
Yes. You can leave the trial at any point, for any reason. Deciding to leave will not affect your standard medical treatment or your relationship with your regular NHS care team.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
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