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MS treatment showdown: does starting strong early prevent disability?

NCT ID NCT03500328

Disease control Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This trial compares two treatment strategies for people with relapsing-remitting multiple sclerosis: starting with high-efficacy drugs early versus starting with standard first-line therapies and switching if needed. The study involves 900 participants across multiple sites and tracks disability progression over time. The goal is to determine whether early aggressive therapy better prevents long-term disability.

What this could mean

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

Active substance
Multiple FDA-approved MS drugs (e.g., natalizumab, ocrelizumab, glatiramer acetate, interferons)
What this could lead to
If successful, this could show that starting with stronger drugs early on helps prevent disability in people with relapsing-remitting MS.
What could go wrong
This is a large pragmatic trial, but results may not apply to all MS patients. Higher-efficacy drugs carry infection risks and other side effects.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

900 people

The number who actually took part.

Started

May 2018

Expected to finish

Sep 2026

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: * Aged 18-60 years * Meets 2017 McDonald criteria for relapsing-remitting MS \[patients with clinically isolated syndrome (CIS) are not eligible\] * Must be EITHER John Cunningham (JC) virus antibody negative or low positive (index antibody titer \<0.9), OR negative for: Hepatitis B and C, tuberculosis * HIV negative * No chemotherapy in past year; if patient has prior history of chemotherapy or malignancy, documentation in chart explaining why potential risks of higher-efficacy therapy are justified Exclusion Criteria: * Prior treatment with rituximab, ocrelizumab, ofatumumab, alemtuzumab, mitoxantrone or cladribine * Prior treatment with any other MS DMT for more than 6 months * Prior treatment with experimental aggressive therapies (e.g., T-cell vaccine, total lymphoid radiation, stem cells) * Treatment with teriflunomide within past 2 years (even for ≤ 6 months), unless rapid wash out done (i.e., with cholestyramine or activated charcoal) * Treatment in the past 6 months with any MS DMT * Prior treatment with any other investigational immune-modulating /suppressing drug for MS not listed above * Pregnant or breast-feeding * Women of child-bearing age who are planning or strongly considering conception during the study time frame

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Conditions

The condition(s) this trial relates to.

multiple sclerosis 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

  • Advanced Neurology Specialists

    Great Falls, Montana, 59405, United States

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Baylor Scott and White Health

    Dallas, Texas, 75246, United States

  • Billings Clinic

    Billings, Montana, 59101, United States

  • Blacksburg Neurology

    Christiansburg, Virginia, 24073, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Christiana Care Health Services, Inc.

    Newark, Delaware, 19713, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • CommonSpirit Health Research Institute

    Carmichael, California, 95608, United States

  • Geisinger Clinic

    Danville, Pennsylvania, 17822, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Neurology Consultants of Tidewater

    Norfolk, Virginia, 23502, United States

  • New York University School of Medicine

    New York, New York, 10016, United States

  • Norton Neurology MS Services

    Louisville, Kentucky, 40207, United States

  • OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104, United States

  • Providence Health and Services - Oregon

    Portland, Oregon, 97225, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Swedish Health Services

    Seattle, Washington, 98122, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160, United States

  • The University of South Alabama

    Mobile, Alabama, 36604, United States

  • The University of Vermont and State Agricultural College

    Burlington, Vermont, 05405, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    San Diego, California, 92037, United States

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Florida

    Gainesville, Florida, 32611, United States

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of South Florida Health

    Tampa, Florida, 33612, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8806, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Washington

    Seattle, Washington, 98133, United States

  • Vanderbilt Comprehensive MS Center

    Nashville, Tennessee, 37215, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

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