Cleveland Clinic Lou Ruvo Center for Brain Health in the US is now recruiting participants for a new, relapsing remitting multiple sclerosis (RRMS) treatment trial, DELIVER-MS. Cleveland Clinic will partner with the University of Nottingham in the UK for this trial. The UK arm has not yet started recruitment.
The purpose of the global, multi-centre study, led by Cleveland Clinic, is to compare the benefits and risks of two common treatment approaches for multiple sclerosis (MS) to determine which the better course is. The first option uses a highly-effective treatment early in the disease state whereas the second is a more standard escalation approach, which uses moderately effective medications and escalates as needed. This is the first time the two approaches have been compared in a head-to-head trial.
"Patients and their doctors are faced with the dilemma of adopting one of two treatment approaches when managing RRMS. Both options have their share of risks and benefits, and we're hoping that our research findings will illuminate the most beneficial choice for patients moving forward," said Carrie Hersh, Staff Neurologist at Lou Ruvo Center for Brain Health and site-principal investigator and study steering committee member. "Cleveland Clinic remains dedicated to putting our patients first and the results of the DELIVER-MS trial will be a valuable resource in helping us better understand how to give the best care possible."
The three-year study will enrol 800 participants who will be divided into two sub-groups: randomised clinical trial and observation. Participants in the randomised clinical trial will be categorised to either the early highly-effective treatment approach or the standard escalation approach.
"DELIVER-MS will help shape the treatment philosophy of RRMS," said Dr Daniel Ontaneda, Clinical Director of the brain donation program at Cleveland Clinic's Mellen Center for Treatment and Research in MS, who serves as the principal investigator for DELIVER-MS. "The results will be applicable to a wide range of patients looking to start currently available and future therapies. The long-term study results at ten years will further help neurologists and people with MS make informed decisions on initial treatments."
Men and women ages 18 to 60 who have been diagnosed with RRMS, are early in their disease course, and have not yet started a disease modifying therapy will be eligible to participate. Additionally, interested participants must be able to show evidence of new MRI lesions or have had relapses over the past 12 months, be able to walk independently or with assistance, and be eligible and willing to follow-up at Lou Ruvo Center for Brain Health during the course of the study.
For more information about DELIVER-MS, visit https://clinicaltrials.gov/ct2/show/NCT03535298. An update will follow when the University of Nottingham begins its recruitment in the UK.
Source: MS-UK 15/03/19