Multiple Sclerosis Clinical Trial

Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

800

Study ID:

NCT03535298

Recruitment Status:

Active, not recruiting

Sponsor:

The Cleveland Clinic

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There are 29 Locations for this study

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University of Colorado-Anschutz Medical Campus
Aurora Colorado, 80045, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic
Rochester Minnesota, 55902, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada, 89106, United States
University of Buffalo
Buffalo New York, 14202, United States
University Rochester Medical Center
Rochester New York, 14642, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio Health
Columbus Ohio, 43214, United States
UT-Austin
Austin Texas, 78712, United States
Baylor College of Medicine, Houston
Houston Texas, 77030, United States
UTHealth-Houston
Houston Texas, 77030, United States
University of Virginia
Charlottesville Virginia, 22903, United States
Virginia Commonwealth University
Richmond Virginia, 23284, United States
University of Wisconsin-Madison
Madison Wisconsin, 53705, United States
University Hospitals Coventry and Warwickshire
Coventry England, CV2 2, United Kingdom
The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary
Leeds England, LS1 3, United Kingdom
University Hospitals Leicester
Leicester England, LE1 5, United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London England, W6 8R, United Kingdom
University College London Hospitals NHS Foundation Trust, University College Hospital
London England, WC1N , United Kingdom
Salford Royal NHS Foundation Trust, Salford Hospital
Manchester England, M6 8H, United Kingdom
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
Oxford England, OX3 9, United Kingdom
University Hospitals Plymouth NHS Trust, Derriford Hospital
Plymouth England, PL6 8, United Kingdom
Sheffield Teaching Hospitals
Sheffield England, S5 7A, United Kingdom
University Hospitals of North Midlands
Stoke England, ST4 6, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh Scotland, EH16 , United Kingdom
Cardiff and Vale University Local Health Board, University Hospital of Wales
Cardiff Wales, CF14 , United Kingdom
Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital
Newport Wales, NP19 , United Kingdom
Swansea Bay University Local Health Board, Morriston Hospital
Swansea Wales, SA6 6, United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Centre
Nottingham , NG7 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

800

Study ID:

NCT03535298

Recruitment Status:

Active, not recruiting

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

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