• Daniel Ontaneda, Emma C Tallantyre, Praneeta C Raza, Sarah M Planchon, Kunio Nakamura, Deborah Miller, Carrie Hersh, Mathew Craner, Clare Bale, Burhan Chaudhry, Douglas D Gunzler, Thomas E Love, Stephen Gerry, Alasdair Coles, Jeffrey A Cohen, and Nikos Evangelou.
• Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland, OH, United States. Electronic address: ontaned@ccf.org.
• Contemp Clin Trials. 2020 Aug 1; 95: 106009.

AbstractMultiple Sclerosis (MS) is a common cause of neurological disability among young adults and has a high economic burden. Currently there are 18 disease modifying agents for relapsing MS, which were tested in clinical trials versus placebo or an active comparator in a pairwise manner. However, there is currently no consensus on the fundamental principles of treatment approach and initial therapy selection. These factors result in variable use of disease modifying therapies. Here we describe the study protocol for Determining the Effectiveness of earLy Intensive Versus Escalation approaches for the Treatment of Relapsing-remitting Multiple Sclerosis (DELIVER-MS). The main objective of the study is to determine whether an early highly effective treatment approach, defined as use of one of four monoclonal antibodies as initial therapy, is more effective than an escalation treatment approach (any other approved medication as initial therapy with subsequent escalation to higher efficacy treatments guided by radiological and clinical evaluation). The primary endpoint of the study is reduction in normalized brain volume loss from baseline visit to month 36 visit using MRI. Brain volume loss was selected as the best short-term predictor of long-term clinical disability. A total of 400 participants will be randomized 1:1 using minimization to account for age and sex by site, and 400 will be enrolled into a parallel observational cohort. The study results will help guide overall treatment philosophy and will have important implications for patient choice, clinical practice, and treatment access.Copyright © 2020 Elsevier Inc. All rights reserved.

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