Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS
NCT ID: NCT03535298
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
800 participants
INTERVENTIONAL
2019-01-03
2027-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EHT: Early Highly-effective
Participants randomized to the "EHT: Early Highly-effective" arm will receive one of the highly effective MS therapies (Ocrevus, Lemtrada, Tysabri, Rituximab, Kesimpta) as their initial disease modifying treatment.
Interventions: one of the highly effective MS therapies
The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Early Highly Effective Therapies Group
Highly Effective MS Therapy group of medications
ESC: Escalation
Participants randomized to the "ESC: Escalation" arm will receive any other approved MS therapy (not one of the EHT group) as their initial disease modifying treatment.
Interventions: one of the MS therapies NOT in the highly effective group
The randomization affects only the INITIAL treatment received. Once that treatment has been initiated, any subsequent changes are made according to standard clinical practice, regardless of randomization group.
Escalation Therapies Group
Escalation MS Therapy group of medications
OBS: Observational
Participants will not be restricted to a group of MS therapies.
Participants enter this arm if they are not comfortable with randomization, are not eligible to receive any of the options in a randomized arm, or are not able to secure insurance coverage for any therapy in a randomized arm.
No interventions assigned to this group
Interventions
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Early Highly Effective Therapies Group
Highly Effective MS Therapy group of medications
Escalation Therapies Group
Escalation MS Therapy group of medications
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Established diagnosis of MS, as defined by the 2017 revision of McDonald Diagnostic Criteria (99).
3. RRMS disease course as defined by the 2013 revisions of the MS clinical course definition (4).
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).
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 each treatment arm.
7. EDSS at Baseline visit ≤ 6.5
Exclusion Criteria
2. 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.
3. 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.
4. 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
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 movement related to tremor.
7. 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.
18 Years
60 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Daniel Ontaneda, MD
Principal Investigator
Principal Investigators
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Daniel Ontaneda, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Nikos Evangelou, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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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
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
Cardiff and Vale University Local Health Board, University Hospital of Wales
Cardiff, Wales, United Kingdom
Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital
Newport, Wales, United Kingdom
Swansea Bay University Local Health Board, Morriston Hospital
Swansea, Wales, United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Centre
Nottingham, , United Kingdom
Countries
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Other Identifiers
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CCF 18-326/23-453
Identifier Type: -
Identifier Source: org_study_id
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