Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (NCT03500328)
A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
- 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)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (47 Sites)
Showing the first 25 of 47 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- The University of South Alabama — Mobile, Alabama
- St. Joseph's Hospital & Medical Center - Barrow Neurological Institute — Phoenix, Arizona
- CommonSpirit Health Research Institute — Carmichael, California
- Cedars-Sinai Medical Center — Los Angeles, California
- University of California, Los Angeles — Los Angeles, California
- University of California, San Diego — San Diego, California
- University of California, San Francisco — San Francisco, California
- Christiana Care Health Services, Inc. — Newark, Delaware
- Georgetown University — Washington D.C., District of Columbia
- University of Florida — Gainesville, Florida
- University of Miami — Miami, Florida
- University of South Florida Health — Tampa, Florida
- Rush University Medical Center — Chicago, Illinois
- The University of Kansas Medical Center (KUMC) — Kansas City, Kansas
- Norton Neurology MS Services — Louisville, Kentucky
- University of Maryland, Baltimore — Baltimore, Maryland
- The Johns Hopkins Hospital — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- University of Massachusetts Medical School — Worcester, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Wayne State University — Detroit, Michigan
- Mayo Clinic — Rochester, Minnesota
- Billings Clinic — Billings, Montana
- Advanced Neurology Specialists — Great Falls, Montana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Sclerosis, Relapsing-Remitting
- Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS — Aurora, Colorado
- A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis — La Jolla, California
- Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis — Altamonte Springs, Florida
- A Post-Authorization, Long-term Study of Ozanimod Real-world Safety — Bethesda, Maryland
- Efficacy of Diet on Quality of Life in Multiple Sclerosis — Iowa City, Iowa
Explore by condition: All Multiple Sclerosis, Relapsing-Remitting clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.