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
- Diseases
- Multiple sclerosis
- 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
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiff and Vale University Local Health Board, University Hospital of Wales Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| University Hospitals Coventry and Warwickshire Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| Royal Infirmary of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| University Hospitals Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust - University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust, Charing Cross Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Salford Royal NHS Foundation Trust, Salford Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust, Queens Medical Centre Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| University Hospitals Plymouth NHS Trust, Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Sheffield Teaching Hospitals Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| University Hospitals of North Midlands Coordinator of this site? Confirm its status | Stoke | United Kingdom | Unknown status |
| Swansea Bay University Local Health Board, Morriston Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| UT-Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University of Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Ohio Health Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Baylor College of Medicine, Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| UTHealth Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Cleveland Clinic Lou Ruvo Center for Brain Health Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.