An upcoming Phase 2 clinical trial, called ChariotMS, will test whether Mavenclad (cladribine) can slow a worsening of hand and arm function in people with progressive multiple sclerosis (MS) and very limited walking abilities.
Patients reliant on wheelchairs or aids to walk even short distances generally have advanced disease, often marked by progression to secondary progressive MS and scores of 6.5 or above on the Expanded Disability Status Scale (EDSS). Advanced patients are typically not included in MS clinical trials, in part because they can use walking ability as a key measure of effectiveness when testing potential disease-modifying therapies (DMTs).
“Finding ways to maintain people’s upper limb function is essential to their quality of life,” Klaus Schmierer, PhD, of Queen Mary University of London and Barts Health NHS Trust, said in a press release.
But trials can exclude “people who depend on a wheelchair from taking part … and, as a result, from accessing effective treatment that will help maintain their hand and arm function,” added Schmierer, who is leading the upcoming study.
Most DMTs today are approved for relapsing-remitting MS, the disease’s most common form.
Rather than focusing on changes in walking ability as an efficacy determinant, ChariotMS will use the Nine Hole Peg Test, a measurement of hand and arm function. Enrolled patients will also undergo MRI scans to assess the treatment’s effect on brain lesions.
The U.K. trial aims to recruit 200 people with EDSS scores between 6.5 and 8.5, meaning they cannot walk more than 20 meters (about 65 feet) using two crutches, or are completely unable to walk. All eligible patients will still retain some function in their arms and hands.
As such, it is open to people with advanced and progressive disease, regardless of whether their MS is primary progressive (PPMS) or secondary progressive (SPMS), without any upper age limit. Patients will be randomly assigned to either Mavenclad or placebo tablets over the study’s 24 months.
Mavenclad, approved to treat highly active relapsing MS, works by killing the immune cells that drive disease-causing inflammation in the nervous system of people with MS.
Historically, it has been thought that inflammation plays less of a role in advanced MS than in earlier stages of disease. However, emerging evidence is challenging this idea, supporting interest in using DMTs like Mavenclad in people with advanced disease.
ChariotMS is being funded in part by Mavenclad’s developer, EMD Serono (Merck KGaA outside of the U.S. and Canada); it is also supported by government agencies and charities, including the MS Society and Barts’ Charity, both in the U.K., and the National MS Society in the U.S.
“Preserving hand and arm function would unquestionably improve the quality of life of people with MS, helping them to live more independent lives. That’s why we’re so thrilled to help make this important trial a reality,” said Emma Gray, PhD assistant director of research at the MS Society.
“We are very pleased to be able to help support this important clinical trial for people with MS for whom there are so few treatment options,” Bruce Bebo, PhD, executive vice president of research for the National MS Society, said in a separate press release.
ChariotMS is set to begin enrollment in 2021 at 20 centers across the United Kingdom, and plans are being put in place to limit the effects of the COVID-19 pandemic on the trial.
Individuals interested in this trial and who think they might be eligible are encouraged to get in touch with their doctors about a possible referral, or to email the study team at [email protected].
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