Results from the DELIVER-MS trial, titled “Determining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (NCT03535298), are expected to provide a framework for overall treatment choices for RRMS.
The three-year global, multi-center trial led by the Cleveland Clinic will enroll about 800 participants. Cleveland Clinic Lou Ruvo Center for Brain Health in Nevada is now one of the trial’s enrolling sites.
The goal of the trial is to compare two common treatment approaches for RRMS. The first option uses a highly effective disease-modifying treatment (DMT) early in disease; the second option is based on a standard escalation approach using moderately effective medications and escalating as needed.
Of note, highly effective DMTs considered in the trial include Lemtrada (alemtuzumab, marketed by Sanofi Genzyme), Tysabri (natalizumab, by Biogen), Ocrevus (ocrelizumab, by Genentech), and rituximab (a therapy used off-label, or outside the approved indications, in MS patients).
These two treatment approaches have never been compared in a head-to-head clinical trial.
“Patients and their doctors are faced with the dilemma of adopting one of two treatment approaches when managing relapsing-remitting multiple sclerosis. 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,” Carrie Hersh, MSc, DO, staff neurologist at Lou Ruvo Center for Brain Health and site-principal investigator, said in a press release.
“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,” Hersh said.
Participants will be divided into two subgroups: randomized clinical trial and observational (no intervention). Randomized participants will be further split into either the early highly effective DMT approach or the standard escalation approach.
The study will collect data on clinical outcomes, including measures for disability and brain function. Brain volume loss — a medium-term outcome that predicts long-term disability — will also be assessed. Participants’ perspectives on their symptoms and quality of life measures will also be evaluated.
The treatment’s safety and tolerability will also be determined, especially regarding potential treatment-emergent adverse effects, adverse effects leading to discontinuation of treatment, or adverse effects of special interest such as infections.
Researchers expect the findings of DELIVER-MS to inform the balance between potential benefits and risks of the two RRMS treatment approaches. The results will help government agencies and insurance payers to make more informed decisions on medication coverage, with the overall cost of long-term disability being a driving factor.
“DELIVER-MS will help shape the treatment philosophy of RRMS,” said Daniel Ontaneda, MD, 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 10 years will further help neurologists and people with MS make informed decisions on initial treatments.”
Adult RRMS patients (ages 18–60) who are early in their disease course and have not yet started treatment with a DMT are eligible to participate in DELIVER-MS. Participants are required to have had relapses over the past year or show evidence of new MRI lesions, be able to walk independently or with assistance, and be eligible and willing to follow up at specific Cleveland Clinic sites throughout the trial.
For more information about DELIVER-MS, including how to enroll, go to the trial’s website, or call Nicolette Harmon at (702) 701-7972.
The Lou Ruvo Center for Brain Health is working in conjunction with Cleveland Clinic in Ohio to conduct the study. The trial will also begin recruiting participants in the U.K. soon.