Sign in

NCT03535298Active, not recruitingPhase 4

Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 31 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
800 (estimated)
First submitted
14 May 2018
Start date
3 Jan 2019
Primary completion date
30 Jul 2027
Lead sponsor
The Cleveland Clinic
NCT number
NCT03535298

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 800
  • From 3 Jan 2019 to the primary completion date, 30 Jul 2027
  • 30 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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
  • 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.

Other

  • Participants with contraindications to all forms of DMT in either of the treatment arms.
  • Participants unable to provide informed consent.

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Cardiff and Vale University Local Health Board, University Hospital of Wales
Coordinator of this site? Confirm its status
CardiffUnited KingdomUnknown status
University Hospitals Coventry and Warwickshire
Coordinator of this site? Confirm its status
CoventryUnited KingdomUnknown status
Royal Infirmary of Edinburgh
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status
The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status
University Hospitals Leicester
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust - University College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Imperial College Healthcare NHS Trust, Charing Cross Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Salford Royal NHS Foundation Trust, Salford Hospital
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital
Coordinator of this site? Confirm its status
NewportUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust, Queens Medical Centre
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
University Hospitals Plymouth NHS Trust, Derriford Hospital
Coordinator of this site? Confirm its status
PlymouthUnited KingdomUnknown status
Sheffield Teaching Hospitals
Coordinator of this site? Confirm its status
SheffieldUnited KingdomUnknown status
University Hospitals of North Midlands
Coordinator of this site? Confirm its status
StokeUnited KingdomUnknown status
Swansea Bay University Local Health Board, Morriston Hospital
Coordinator of this site? Confirm its status
SwanseaUnited KingdomUnknown status
University of Colorado Anschutz Medical Campus
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
UT-Austin
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
University of Buffalo
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Ohio Health
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Baylor College of Medicine, Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
UTHealth Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Cleveland Clinic Lou Ruvo Center for Brain Health
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
University of Wisconsin - Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Virginia Commonwealth University
Coordinator of this site? Confirm its status
RichmondUnited StatesUnknown status
University Rochester Medical Center
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.