Patients in the UK are to be involved in answering the single most important question about treating multiple sclerosis (MS), as part of a $10 million international clinical trial.
Scientists and clinicians in Nottingham are joining forces with collaborators in the US for the five-year study, which will assess whether giving MS patients the strongest available medicines from the beginning of their illness is more effective than waiting for the disease to progress first.
The UK arm of the trial, which will run at eight centres across the country, will be led by Dr Nikos Evangelou at the University of Nottingham, in partnership with neurologists at Nottingham University Hospitals (NUH) NHS Trust.
Dr Evangelou said: “The Nottingham team is delighted to have played a role in making this study possible. This is a joint effort between neurologists, patients with MS and MS societies in the UK and US coming together to tackle the most important question in MS treatment – how intensive should the initial treatment of MS be?
“As we diagnose MS, we still don’t know how best to treat it. Some doctors advocate hitting the disease hard to avoid the damage and disability that can develop early, and some suggest going more slowly to avoid potential side effects of the medicine.
“Currently, across the UK, the variability of treatments used in different centres is staggering. This is a reflection of the fact that little is known about how best to treat it and this is what we are attempting to tackle.”
MS is a neurological condition affecting the brain and the spinal cord in which myelin – the coating which protects the nerves - is damaged, causing a range of symptoms. The damage is caused when the patient’s own immune system, which normally helps to fight off infections, mistakes myelin for a foreign body and attacks it. The myelin is stripped off the nerve fibres, either slightly or completely, leaving scars known as lesions or plaques and disrupting the nerve’s ability to carry messages between the brain and the rest of the body.
More than 100,000 people in the UK have MS. Symptoms usually start in your 20s and 30s and it affects almost three times as many women as men.
Symptoms commonly include problems with vision and balance, dizziness, fatigue, bladder problems and stiffness and/or spasms. MS can also affect memory and thinking, and have an impact on emotions.
The major international trial – funded by the Patient-Centered Outcomes Research Institute in the US – is being co-led by Dr Daniel Ontaneda at the Cleveland Clinic Foundation.
The trial will recruit 800 patients – half in the US and half in the UK – and will compare the effects of treating with an early highly effective treatment (EHT) approach to an escalation approach.
The study will aim to determine which approach better slows brain volume loss, is safer, more effective, and better tolerated by patients. It will measure how well the participants are functioning in several areas, including cognition, arm and leg function, and eyesight. The researchers will ask patients for their perspective on their MS symptoms, quality of life and satisfaction with their treatment. They will also monitor any potential side effects, as treatment choices in MS are influenced by not only the potential benefits of treatment, but also—importantly—the perceived risks.
The study is being supported by The MS Society, which has provided £100,000 seed funding to develop the initiative through its UK MS Clinical Trials Network (CTN). Through its James Lind Alliance Priority Setting Partnership, it asked people with MS what MS research questions they thought was most important - "Does early treatment with aggressive disease modifying therapies (DMTs) improve the prognosis for people with MS?" was one of their top 10 priorities.
Dr Susan Kohlhaas, Interim Director of Research at the MS Society said: “There are more than 100,000 people living with MS in the UK, and it is vital we find the right treatments for all of them. MS is an unpredictable condition that is different for everyone, making it difficult for people to know how to balance the risks and benefits of intensive treatments.
“We’re proud to have supported the development of this programme through our Clinical Trial Network and look forward to these important questions being answered.”
Trial centres will be based in at Nottingham, Cardiff, Oxford, Cambridge, Plymouth, University College London, Morriston Hospital and Royal Gwent Hospital.
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