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.
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.
Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
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University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233
The University of South Alabama, Mobile, Alabama, United States, 36604
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute, Phoenix, Arizona, United States, 85013
CommonSpirit Health Research Institute, Carmichael, California, United States, 95608
Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048
University of California, Los Angeles, Los Angeles, California, United States, 90095
University of California, San Diego, San Diego, California, United States, 92037
University of California, San Francisco, San Francisco, California, United States, 94158
Christiana Care Health Services, Inc., Newark, Delaware, United States, 19713
Georgetown University, Washington, District of Columbia, United States, 20007
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 60 Years
ALL
No
Johns Hopkins University,
Ellen M. Mowry, MD, MCR, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
Scott D. Newsome, DO, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
2026-08-01