Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

Running, not enrolling · Phase 4

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.

Key facts

Study ID

NCT03535298

Run by

The Cleveland Clinic

People needed

800

Starts

2019-01-03

Expected to finish

2027-07-30

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18 to 60 years.
• Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
• RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
• Participants must have evidence of active disease based on: one or more MS relapses within the last 18 months prior to screening visit or radiological evidence of MS activity (≥2 new T2 lesions within the last 12 months from screening [compared to a previous recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brain or spinal cord MRI performed within the last 12 months of screening).
• Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).
• Participants must be eligible to receive at least one form of DMT within each treatment arm.
• EDSS at Baseline visit ≤ 6.5

You may not qualify if…

• Participants with contraindications to all forms of DMT in either of the treatment arms.
• Participants must never have received any of the following medications: natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferon beta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximel fumarate, ozanimod, monomethyl fumarate, ponesimod.
• Participants must have not received any of the following medications, for reasons other than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, other monoclonal antibodies.
• Participants with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study
• Participants unable to provide informed consent.
• Contraindication or inability to undergo MRI with Gd due to metal or metal implants, allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movement related to tremor.
• Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.

Where it is running

• University of Colorado-Anschutz Medical Campus — Aurora, Colorado, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
• University of Buffalo — Buffalo, New York, United States
• University Rochester Medical Center — Rochester, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio Health — Columbus, Ohio, United States
• UT-Austin — Austin, Texas, United States
• Baylor College of Medicine, Houston — Houston, Texas, United States
• UTHealth-Houston — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States
• University Hospitals Coventry and Warwickshire — Coventry, England, United Kingdom
• The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary — Leeds, England, United Kingdom
• University Hospitals Leicester — Leicester, England, United Kingdom
• Imperial College Healthcare NHS Trust, Charing Cross Hospital — London, England, United Kingdom
• University College London Hospitals NHS Foundation Trust, University College Hospital — London, England, United Kingdom
• Salford Royal NHS Foundation Trust, Salford Hospital — Manchester, England, United Kingdom
• Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital — Oxford, England, United Kingdom
• University Hospitals Plymouth NHS Trust, Derriford Hospital — Plymouth, England, United Kingdom
• Sheffield Teaching Hospitals — Sheffield, England, United Kingdom
• University Hospitals of North Midlands — Stoke, England, United Kingdom

Full record on ClinicalTrials.gov

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