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, ofatumumab, 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. An optional biobanking substudy will be offered at select sites. Study participation will range from 2-6+ years, 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 TREATMS@jhmi.edu 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:

• National Multiple Sclerosis Society
• The Consortium of Multiple Sclerosis Centers

Information for TREAT-MS trial participants

More than twenty FDA-approved therapies for multiple sclerosis (MS) and one therapy approved for other conditions that is often prescribed off-label as a therapy for MS* are classified below for the purpose of the TREAT-MS trial. Additional MS medications considered generic versions of, or bioequivalent or biosimilar to, ones listed below that become FDA approved for marketing in the remaining 2 years of the trial will be added to this table and automatically included for use in the trial upon FDA approval. Please visit this website regularly to stay up-to-date and ask your provider to discuss any new MS medications that have been added to the trial at each remaining follow-up visit so you are aware of your ongoing treatment options.

^@ ODT: orally disintegrating tablet

TREAT-MS Sites

Site	Principal Investigator	Contact
University of Alabama at Birmingham Birmingham, AL	William Meador, MD	Alicia Hill afhill@uabmc.edu
University of South Alabama Mobile, AL	William Kilgo, MD	Zane Patterson zpatterson@health.southalabama.edu
St. Joseph’s Hospital & Medical Center – Barrow Neurological Institute Phoenix, AZ	Aimee Borazanci, MD	Emily Aliskevich emily.aliskevich@commonspirit.org
Cedars-Sinai Medical Center Los Angeles, CA	Nancy Sicotte, MD	Diana Ayrapetyan diana.ayrapetyan@cshs.org
Blacksburg Neurology Christiansburg, VA	Jill Cramer, MD	Julie Kidd jkiddroanokems@gmail.com
CommonSpirit Health Sacramento, CA	Sabeen Lulu, MD	Lucy Ng, MA, CCRC Lucy.Ng-Price@commonspirit.org
University of California, San Diego San Diego, CA	Jennifer S. Graves, MD, PhD, MAS	Soha Fardad sofardad@health.ucsd.edu
University of California, San Francisco San Francisco, CA	Emmanuelle L Waubant, MD, PhD	Alina Dobai alinaloredana.dobai@ucsf.edu
Georgetown University Washington, DC	Carlo Tornatore, MD	Aastha Bhatnagar ab4004@georgetown.edu
Christiana Care Health Services, Inc. Newark, DE	Jason Silversteen, DO	Stephanie Mraz stephanie.n.mraz@christianacare.org
University of Florida Gainesville, FL	Torge Rempe, MD	Amanda Fessenden amanda.fessenden@neurology.ufl.edu
University of Miami Miami, FL	Leticia Tornes, MD	Reshma Richardson rrichardson2@med.miami.edu
University of South Florida Health Tampa, FL	Derrick Robertson, MD	Pamela Acosta-Torres pacostatorres@usf.edu
Rush University Medical Center Chicago, IL	Thomas Shoemaker, MD	Elizabeth Dvorak elizabeth_dvorak@rush.edu
The University of Kansas Medical Center (KUMC) Kansas City, KS	Sharon Lynch, MD	Lisa Schmidt, LPN LSCHMIDT@kumc.edu
Norton Neurology MS Services Louisville, KY	Geeta Ganesh, MD	Jackie Bourke jackie.bourke@nortonhealthcare.org
Massachusetts General Hospital Boston, MA	Eric Klawiter, MD, MSc	Uriel Martinez umartinez1@mgh.harvard.edu
University of Massachusetts Medical School Worcester, MA	Carolina Ionete, MD	Mariana Kurban mariana.kurban@umassmed.edu
The Johns Hopkins Hospital Baltimore, MD	Ellen Mowry, MD, MCR and Scott Newsome, DO	Mason Kruse-Hoyer, MD TREATMS@jhmi.edu
University of Maryland, Baltimore Baltimore, MD	Daniel Harrison, MD	Kerry Naunton, RN, MSCN, CCRC knaunton@som.umaryland.edu
University of Michigan Ann Arbor, MI	Tiffany Braley, MD, MS	Kim Duval kduval@med.umich.edu
Wayne State University Detroit, MI	Evanthia Bernitsas, MD	Zaima Liaquat zaimaliaquat@wayne.edu
Mayo Clinic Rochester, MN	W. Oliver Tobin, MB, BCh, BAO, PhD	Melissa Bush bush.melissa1@mayo.edu
Billings Clinic Billings, MT	Sara Qureshi, MD	Amy Harmala, LPN aharmala@billingsclinic.org
Hackensack University Medical Center  Hackensack, NJ	Krupa Pandey, MD	Michelle Williams michelle.williams@hmhn.org
Columbia University Medical Center New York, NY	Claire Riley, MD	Shirish KC sk5237@cumc.columbia.edu
Icahn School of Medicine at Mount Sinai New York, NY	Ilana Katz Sand, MD	Susan Filomena susan.e.filomena@mssm.edu
New York University School of Medicine New York, NY	Tyler Smith, MD	Nadine Azmy nadin.azmy@nyulangone.org
University of Cincinnati Cincinnati, OH	Aram Zabeti, MD	Kristine Suder suderkl@ucmail.uc.edu
OhioHealth Research Institute Columbus, OH	Geoffrey Eubank, MD	Erin Given erin.given@ohiohealth.com
Oklahoma Medical Research Foundation Oklahoma City, OK	Gabriel Pardo, MD	Micki Drake micki-drake@omrf.org
Providence Health and Services – Oregon Portland, OR	Stanley Cohan, MD, PhD	Noah Pounds noah.pounds@providence.org
Geisinger Clinic Danville, PA	Megan Esch, MD	Chelsie Derr cmderr1@geisinger.edu
Allegheny Health Network Research Institute Pittsburgh, PA	Troy Desai, MD	Mary Fetter Mary.Fetter@ahn.org
Vanderbilt Comprehensive MS Center Nashville, TN	Siddharama Pawate, MD	Pranathi Matta pranathi.matta@vumc.org
University of Utah Salt Lake City, UT	John W. Rose, MD	Ka-Ho Wong Ka-ho.wong@hsc.utah.edu
The University of Vermont and State Agricultural College Burlington, VT	Andrew Solomon, MD	Jane Low, MPA, CCRC Jane.Low@uvmhealth.org
Swedish Medical Center Seattle, WA	Peiqing Qian, MD	Mark Loreen mark.loreen@swedish.org
University of Washington Seattle, WA	Gloria von Geldern, MD	Elisa McGee emcgee@uw.edu
Medical College of Wisconsin Milwaukee, WI	Ahmed Obeidat, MD, PhD	Alexis Micale amicale@mcw.edu
University of Texas Southwestern Medical Center Dallas, TX	Peter Sguigna, MD	Tom Punnen tom.punnen@utsouthwestern.edu
University of Nebraska Medical Center Omaha, NE	Rana Zabad, MD	Melanie McFarland memcfarland@unmc.edu