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DELIVER-MS
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Purpose
To determine whether an Early Highly Effective Treatment (EHT) approach to Disease Modifying Therapy (DMT) as first-line therapy, is more effective than an escalation of treatment approach in reducing normalized whole brain volume loss measured using MRI in patients with Relapsing Remitting Multiple Sclerosis (RRMS) from Baseline to Month 36.
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Patient Population
Adult men and women aged 18-60 years, inclusive, with established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria, with RRMS.
Participants must have evidence of active disease, and enrolled participants must be ambulatory with disease onset within 5 years, treatment naïve, and eligible to receive at least one DMT in each arm.
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Research Method
DELIVER-MS is a multi-center, pragmatic, comparative effectiveness, randomized, clinical trial with additional-parallel observational cohort. The study is hosted across multiple sites in the Unites States and United Kingdom. The measurements of progress are brain loss volume and Expanded Disability Status Score (EDSS) from Baseline to Month 36.
Clinical Trial Information
https://clinicaltrials.gov/study/NCT03535298?term=DELIVER-MS&rank=1
Status: Active, Not Recruiting
The DELIVER-MS Study at the University of Texas at Austin
Location: UT Health Austin, MS and Neuroimmunology Center
Dell Medical School
Local site principal investigator: Leorah Freeman, MD, PhD
Research coordinators: Alejandra Gomez-Lopez, BA; Gabriella Cozzani, BSA
Sponsor
The Cleveland Clinic
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