Clinical trialNCT03500328Active, not recruitingInterventional

Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

SponsorJohns Hopkins UniversityEnrollment900Multiple Sclerosis, Relapsing-Remitting

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Ellen M. Mowry, MD, MCR
Johns Hopkins University
Principal Investigator
clinicaltrials.gov ↗
Scott D. Newsome, DO
Johns Hopkins University
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

47 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
the University of South Alabama
Mobile, Alabama, United States
St. Joseph'S Hospital & Medical Center - Barrow Neurological Institute
Phoenix, Arizona, United States
Commonspirit Health Research Institute
Carmichael, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida Health
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
the University of Kansas Medical Center (kumc)
Kansas City, Kansas, United States
Norton Neurology Ms Services
Louisville, Kentucky, United States
the Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Billings Clinic
Billings, Montana, United States
Advanced Neurology Specialists
Great Falls, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
New York University School of Medicine
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohiohealth Research Institute
Columbus, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Providence Health and Services - Oregon
Portland, Oregon, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
Vanderbilt Comprehensive Ms Center
Nashville, Tennessee, United States
Baylor Scott and White Health
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States

7 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 May 2018
Primary completion: 31 Jul 2026
Completion: 31 Aug 2026
Last update posted: 5 Aug 2026
Registered enrollment: 900
Registry id: NCT03500328

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.