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Ativo, mas não recrutandoFASE2, FASE3INTERVENCIONISTA

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.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2, FASE3
Patrocinador
Universidade Queen Mary de Londres
Meta de inscrição
204
Iniciar
25 Jun 2021
Conclusão estimada
31 Dez 2027

Sobre o que é este estudo?

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.

Pontos principais

  • 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.

Quem pode ser elegível?

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.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. I am aged 18 or older and have a confirmed diagnosis of MS.
  2. I have advanced MS and use a wheelchair for most or all of my mobility.
  3. I have noticed that my hand or arm function has gotten worse over the last two years.
  4. I still have enough control in at least one hand to pick up and move small objects.
  5. I am up to date with routine NHS cancer screening invitations.
  6. I do not have serious heart, liver, or kidney problems, or active serious infections.
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

You may not receive any direct medical benefit from joining this study, especially if you are placed in the placebo group. However, if cladribine works, it may help you keep your hand and arm strength for longer. The knowledge gained will also help improve care for people with advanced MS in the future. Cladribine can lower your white blood cell count, which may temporarily increase your risk of infections. The medical team will monitor you closely with blood tests to catch and treat any issues early. Taking part is completely voluntary, and you are free to leave the study at any time without it affecting your regular NHS care.

Localizações (22)

  • Queens University Belfast (Belfast Health and Social Care Trust)
    Código postal verificado
    Belfast, Reino Unido
  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
    Código postal verificado
    Birmingham, Reino Unido
  • Cardiff University Hospital
    Código postal verificado
    Cardiff, United Kingdom
  • University Hospitals of Coventry and Warwickshire NHS Trust
    Código postal verificado
    Coventry, United Kingdom
  • Anne Rowling Clinic, University of Edinburgh
    Código postal verificado
    Edimburgo, Reino Unido
  • Queen Elizabeth University Hospital Glasgow
    Código postal verificado
    Glasgow, Reino Unido
  • University Hospital Hairmyres, NHS Lanarkshire
    Código postal verificado
    Glasgow, Reino Unido
  • Leeds Teaching Hospitals NHS Trust
    Código postal verificado
    Leeds, United Kingdom
  • Walton Centre NHS Trust
    Código postal verificado
    Liverpool, Reino Unido
  • Royal London Hospital
    Código postal verificado
    Londres, Reino Unido
  • Royal Free London NHS Foundation Trust
    Código postal verificado
    Londres, Reino Unido
  • Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust)
    Código postal verificado
    Londres, Reino Unido

Perguntas frequentes

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.

Posso sair do estudo se mudar de ideia?

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.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

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