Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
Public ClinicalTrials.gov record NCT03500328. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03500328
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 900 participants
Conditions and interventions
Conditions
Interventions
- Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq Other
- Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod Other
Other
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2018
- Primary completion
- Jul 30, 2026
- Completion
- Aug 31, 2026
- Last update posted
- Sep 1, 2026
2018 – 2026
United States locations
- U.S. sites
- 47
- U.S. states
- 28
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| The University of South Alabama | Mobile | Alabama | 36604 | — |
| St. Joseph's Hospital & Medical Center - Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| CommonSpirit Health Research Institute | Carmichael | California | 95608 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| University of California, San Diego | San Diego | California | 92037 | — |
| University of California, San Francisco | San Francisco | California | 94158 | — |
| Christiana Care Health Services, Inc. | Newark | Delaware | 19713 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| University of Miami | Miami | Florida | 33136 | — |
| University of South Florida Health | Tampa | Florida | 33612 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| The University of Kansas Medical Center (KUMC) | Kansas City | Kansas | 66160 | — |
| Norton Neurology MS Services | Louisville | Kentucky | 40207 | — |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Advanced Neurology Specialists | Great Falls | Montana | 59405 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Providence Health and Services - Oregon | Portland | Oregon | 97225 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | — |
| Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | 15212 | — |
| Vanderbilt Comprehensive MS Center | Nashville | Tennessee | 37215 | — |
| Baylor Scott and White Health | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8806 | — |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| The University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| Blacksburg Neurology | Christiansburg | Virginia | 24073 | — |
| Neurology Consultants of Tidewater | Norfolk | Virginia | 23502 | — |
| Swedish Health Services | Seattle | Washington | 98122 | — |
| University of Washington | Seattle | Washington | 98133 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03500328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03500328 live on ClinicalTrials.gov.