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Which MS treatment strategy preserves the brain better?

NCT ID NCT03535298

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial asks whether starting with highly effective MS drugs right away is better than starting with milder drugs and switching to stronger ones only if needed. Researchers will follow about 800 adults with relapsing-remitting MS for several years, using MRI scans and disability measures to compare the two approaches. The goal is to see which strategy better slows brain volume loss and delays disability progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Highly effective MS therapies (alemtuzumab, ocrelizumab, natalizumab, rituximab, ofatumumab, ublituximab) versus escalation therapies (beta interferon, glatiramer acetate, teriflunomide, fingolimod, dimethyl fumarate, cladribine, and others)
What this could lead to
If early intensive treatment works better, it could change how doctors prescribe MS drugs, leading to better long-term outcomes for people with relapsing-remitting MS.
What could go wrong
The trial is large but still one study; results may not apply to all patients. Highly effective drugs carry risks like infections, and the escalation approach may be safer for some.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Men and women aged 18 to 60 years. 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: 1. Participants with contraindications to all forms of DMT in either of the treatment arms. 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.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis, relapsing-remitting

Contacts and locations

Locations

  • Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital

    Newport, Wales, NP19 0BH, United Kingdom

  • Baylor College of Medicine, Houston

    Houston, Texas, 77030, United States

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

    Cardiff, Wales, CF14 4XW, United Kingdom

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106, United States

  • Imperial College Healthcare NHS Trust, Charing Cross Hospital

    London, England, W6 8RF, United Kingdom

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Nottingham University Hospitals NHS Trust, Queens Medical Centre

    Nottingham, NG7 2UH, United Kingdom

  • Ohio Health

    Columbus, Ohio, 43214, United States

  • Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital

    Oxford, England, OX3 9DU, United Kingdom

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • Salford Royal NHS Foundation Trust, Salford Hospital

    Manchester, England, M6 8HD, United Kingdom

  • Sheffield Teaching Hospitals

    Sheffield, England, S5 7AT, United Kingdom

  • Swansea Bay University Local Health Board, Morriston Hospital

    Swansea, Wales, SA6 6NL, United Kingdom

  • The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary

    Leeds, England, LS1 3EX, United Kingdom

  • UT-Austin

    Austin, Texas, 78712, United States

  • UTHealth-Houston

    Houston, Texas, 77030, United States

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

    London, England, WC1N 3BG, United Kingdom

  • University Hospitals Coventry and Warwickshire

    Coventry, England, CV2 2DX, United Kingdom

  • University Hospitals Leicester

    Leicester, England, LE1 5WW, United Kingdom

  • University Hospitals Plymouth NHS Trust, Derriford Hospital

    Plymouth, England, PL6 8DH, United Kingdom

  • University Hospitals of North Midlands

    Stoke, England, ST4 6QG, United Kingdom

  • University Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Buffalo

    Buffalo, New York, 14202, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Colorado-Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

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