Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

Last updated: July 30, 2024
Sponsor: The Cleveland Clinic
Overall Status: Active - Not Recruiting

Phase

4

Condition

Scar Tissue

Multiple Sclerosis

Memory Loss

Treatment

Early Highly Effective Therapies Group

Escalation Therapies Group

Clinical Study ID

NCT03535298
CCF 18-326
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women aged 18 to 60 years.

  2. Established diagnosis of MS, as defined by the 2017 revision of McDonald DiagnosticCriteria (99).

  3. RRMS disease course as defined by the 2013 revisions of the MS clinical coursedefinition (4).

  4. Participants must have evidence of active disease based on: one or more MS relapseswithin the last 18 months prior to screening visit or radiological evidence of MSactivity (≥2 new T2 lesions within the last 12 months from screening [compared to aprevious recent MRI within 18 months of screening] or ≥1 GdE demonstrated on brainor spinal cord MRI performed within the last 12 months of screening).

  5. Participants must be ambulatory with disease onset ≤ 5 years and treatment-naïve (i.e., no MS DMT at any time in the past).

  6. Participants must be eligible to receive at least one form of DMT within eachtreatment arm.

  7. EDSS at Baseline visit ≤ 6.5

Exclusion

Exclusion Criteria:

  1. Participants with contraindications to all forms of DMT in either of the treatmentarms.

  2. Participants must never have received any of the following medications: natalizumab,alemtuzumab, ocrelizumab, rituximab, ofatumumab, cladribine, siponimod, interferonbeta-1a, interferon beta-1b, pegylated interferon beta-1a, glatiramer acetate,fingolimod, teriflunomide, dimethyl fumarate, daclizumab, mitoxantrone, diroximelfumarate, ozanimod, monomethyl fumarate, ponesimod.

  3. Participants must have not received any of the following medications, for reasonsother than MS, in the last 12 months: cyclophosphamide, azathioprine, mycophenolatemofetil, cyclosporine, methotrexate, leflunomide, laquinimod, atacicept, othermonoclonal antibodies.

  4. Participants with clinically relevant medical or surgical conditions that, in theopinion of the investigator, would put the subject at risk by participating in thestudy

  5. Participants unable to provide informed consent.

  6. Contraindication or inability to undergo MRI with Gd due to metal or metal implants,allergy to Gd contrast, claustrophobia, pain, spasticity, or excessive movementrelated to tremor.

  7. Unwillingness or inability to comply with the requirements of this protocolincluding the presence of any condition (physical, mental, or social) that, in theopinion of the PI, is likely to affect the participant's ability to comply with thestudy protocol.

Study Design

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: Early Highly Effective Therapies Group
Phase: 4
Study Start date:
January 03, 2019
Estimated Completion Date:
September 30, 2030

Connect with a study center

  • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

    Cambridge, England CB2 0AH
    United Kingdom

    Site Not Available

  • University Hospitals Coventry and Warwickshire

    Coventry, England CV2 2DX
    United Kingdom

    Site Not Available

  • Frimley Park

    Frimley, England GU16 7UJ
    United Kingdom

    Site Not Available

  • The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary

    Leeds, England LS1 3EX
    United Kingdom

    Site Not Available

  • University Hospitals Leicester

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital

    London, England W6 8RF
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust, University College Hospital

    London, England WC1N 3BG
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust, Salford Hospital

    Manchester, England M6 8HD
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital

    Oxford, England OX3 9DU
    United Kingdom

    Site Not Available

  • University Hospitals Plymouth NHS Trust, Derriford Hospital

    Plymouth, England PL6 8DH
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals

    Sheffield, England S5 7AT
    United Kingdom

    Site Not Available

  • University Hospitals of North Midlands

    Stoke, England ST4 6QG
    United Kingdom

    Site Not Available

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland EH16 4SA
    United Kingdom

    Site Not Available

  • Cardiff and Vale University Local Health Board, University Hospital of Wales

    Cardiff, Wales CF14 4XW
    United Kingdom

    Site Not Available

  • Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital

    Newport, Wales NP19 0BH
    United Kingdom

    Site Not Available

  • Swansea Bay University Local Health Board, Morriston Hospital

    Swansea, Wales SA6 6NL
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust, Queens Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • University of Colorado-Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • University of Buffalo

    Buffalo, New York 14202
    United States

    Site Not Available

  • University Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio Health

    Columbus, Ohio 43214
    United States

    Site Not Available

  • UT-Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • Baylor College of Medicine, Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • UTHealth-Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Site Not Available

  • University of Wisconsin-Madison

    Madison, Wisconsin 53705
    United States

    Site Not Available

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