Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

Running, not enrolling · Not applicable

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT03500328

Run by

Johns Hopkins University

People needed

900

Starts

2018-05-02

Expected to finish

2026-08-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• The Johns Hopkins Hospital — 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

Full record on ClinicalTrials.gov

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