The TREAT-MS Clinical Trial for Multiple Sclerosis (MS) Patients

An Exciting Interview from the PCORI Annual Meeting

Ellen Mowry, an associate professor of neurology at Johns Hopkins University, is the principal investigator on a PCORI-funded pragmatic clinical study that aims to provide clarity for clinicians on which disease modifying therapy should be prescribed for patients living with multiple sclerosis.

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About TREAT-MS

There is an unmet need to identify if specific treatment strategies during the relapsing-remitting phase of multiple sclerosis (MS) can prevent, delay, or reduce longer-term disability. Currently, there is a lack of evidence-based guidelines to help clinicians and patients determine which treatment strategy is best for an individual with MS. In addition, it is unclear when people with MS, in the setting of breakthrough disease activity, should switch therapies and whether to consider a different first-line therapy or if they should escalate immediately to higher-efficacy therapies.

The TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial will help inform patients and the broader healthcare community on whether patients would most benefit from early, possibly more risky aggressive therapy or if starting with a less aggressive (and, often, less risky) therapy, followed by a switch if breakthrough disease activity occurs, is warranted. In addition, this study will help identify if there is a specific patient population or short-term biomarker(s) that is strongly predictive of long-term disability that can result from MS.

The TREAT-MS Trial is a randomized controlled trial that will recruit 900 patients across approximately 45 sites within the United States. In order to be eligible, participants must have relapsing-remitting MS and be between the ages of 18 and 60 years. Participants will need to be eligible for at least one of the higher-efficacy therapies based on screening labs. Participants are not eligible if they have had more than 6 months’ exposure to one or more MS disease-modifying therapies or prior treatment with rituximab, ocrelizumab, alemtuzumab, mitoxantrone, cladribine, or an experimental aggressive therapy.

Participants that meet the eligibility criteria will initially be divided into two groups based on suspected risk(s) for long-term disability. The first group will include those with “high-risk” indicators for aggressive disease versus “low-risk.” Within each group, eligible participants will be randomized 1:1, to either a “higher-efficacy” therapy (i.e., infusible therapies) versus traditional, first-line therapy (injectable and oral therapies). Participants and their neurology specialist will choose the therapy within the category that participants are randomized to that is most appropriate for them. Those deemed at low risk for disability who are initially randomized to a traditional therapy and who experience breakthrough disease activity will be re-randomized to a higher-efficacy therapy or to a different traditional therapy. An extremely important goal for any intervention is to help improve or maintain a high quality of life; therefore, in addition to classic clinical endpoints (i.e., slowing disability progression), patient-reported outcomes will be obtained in order to gain a better understanding of the full impact of a treatment. Study participation will range from 42 – 54 months, depending on enrollment date and study related activities will occur around a participant’s standard of care visits.

For more information on the TREAT-MS trial, please email the team at Johns Hopkins at This email address is being protected from spambots. You need JavaScript enabled to view it. and we will connect you with a participating site in your area.

Principal Investigators: Ellen M. Mowry, MD, MCR & Scott D. Newsome, DO

Sponsor: Johns Hopkins University School of Medicine

Application No: IRB00143534 

For a complete list of participating sites and contact information: ClinicalTrials.gov

To know more about Multiple Sclerosis:

TREAT-MS Sites

Site Principal Investigator Contact
University of Alabama at Birmingham
Birmingham, AL
William Meador, MD Sarah M. Dowdy, MPH 
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St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
Phoenix, AZ
Ram Narayan, MD Stacey Lent, CCRC
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Cedars-Sinai Medical Center
Los Angeles, CA
Nancy Sicotte, MD Cedars-Sinai MS Research Coordinator
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University of California, Los Angeles
Los Angeles, CA
Barbara Giesser, MD William Swearingen
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Dignity Health Medical Foundation
Sacramento, CA
Sabeen Lulu, MD Lucy Ng, MA, CCRC
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University of California, San Diego
San Diego, CA
Jennifer S. Graves, MD, PhD, MAS Miryam Palomino
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University of California, San Francisco
San Francisco, CA
Emmanuelle L Waubant, MD, PhD Liliana Espinosa
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Georgetown University
Washington, DC
Carlo Tornatore, MD Derek Haase
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Christiana Care Health Services, Inc.
Newark, DE
Jason Silversteen, MD Kathleen, Greenbaum, MSN, RN, CCRC, CDE
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University of Florida
Gainesville, FL
Tirisham Gyang, MD Victoria Hope
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University of Miami
Miami, FL
Leticia Tornes, MD Yanet Babcock
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University of South Florida Health
Tampa, FL
Derrick Robertson, MD Angela Aungst
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Rush University Medical Center
Chicago, IL
Michael Ko, MD Rosemarie R. Baligod, RN, BSN
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The University of Kansas Medical Center (KUMC)
Kansas City, KS
Sharon Lynch, MD Lisa Schmidt, LPN
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Norton Neurology MS Services
Louisville, KY
Geeta Ganesh, MD Deborah Lockridge, RN, BSN, MSCN, CCRC
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Massachusetts General Hospital
Boston, MA
Eric Klawiter, MD, MSc Anna Vaeth
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Andrew Russo
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University of Massachusetts Medical School
Worcester, MA
Andrew Bouley, MD Irina RaduM
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Rena Yaghmour
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The Johns Hopkins Hospital
Baltimore, MD
Ellen Mowry, MD, MCR and Scott Newsome, DO Jen Chalayon
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University of Maryland, Baltimore
Baltimore, MD
Daniel Harrison, MD Kerry Naunton, RN, MSCN, CCRC
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University of Michigan
Ann Arbor, MI
Yang Mao-Draayer, MD Michael Hadden
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Wayne State University
Detroit, MI
Evanthia Bernitsas, MD Melody Hackett
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Mayo Clinic
Rochester, MN
W. Oliver Tobin, MB, BCh, BAO, PhD Katie Doane
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Billings Clinic
Billings, MT
Sara Qureshi, MD Amy Harmala, LPN
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Advanced Neurology Specialists
Great Falls, MT
Dennis Dietrich, MD Laura Armstrong, LPN
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Hackensack University Medical Center 
Hackensack, NJ
Krupa Pandey, MD Lee Ifhar, MSc
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St. Barnabas Medical Center
Livingston, NJ
Matthew Tremblay, MD, PhD Carissa Greco
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Columbia University Medical Center
New York, NY
Claire Riley, MD Kaho Onomichi
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Icahn School of Medicine at Mount Sinai
New York, NY
Aaron Miller, MD Susan Filomena
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New York University School of Medicine
New York, NY
Lana Zhovtis Ryerson, MD Dunia Gragui
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Stony Brook University
Stony Brook, NY
Patricia Coyle, MD Jessica Lamb
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University of Cincinnati
Cincinnati, OH
Elizabeth Dragan, MD Tiffany Rupert
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Ashley Fisher, CCRC
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OhioHealth Research Institute
Columbus, OH
Geoffrey Eubank, MD Fama Diallo
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Oklahoma Medical Research Foundation
Oklahoma City, OK
Gabriel Pardo, MD Micki Drake
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Providence Health and Services - Oregon
Portland, OR
Elisabeth Lucassen, MD Will Stott
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Geisinger Clinic
Danville, PA
Megan Esch, MD Chelsie Derr
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Allegheny Health Network Research Institute
Pittsburgh, PA
Troy Desai, MD Mary Fetter
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Vanderbilt Comprehensive MS Center
Nashville, TN
Siddharama Pawate, MD

Kehaunani Hubbard
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Baylor Scott and White Health
Dallas, TX
Annette F. Okai, MD Samantha Villa
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Central Texas Neurology Consultants
Round Rock, TX
Edward J. Fox, MD, PhD Alexandra Guerra
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University of Utah
Salt Lake City, UT
John W. Rose, MD Ka Ho Wong
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Neurology Consultants of Tidewater
Norfolk, VA
Ingrid Loma-Miller, MD Veda Byrd
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The University of Vermont and State Agricultural College
Burlington, VT
Andrew Solomon, MD Jane Low, MPA, CCRC
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University of Washington
Seattle, WA
Gloria von Geldern, MD Elisa McGee
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