Evidence map›Paper›PMID 41135813›Full record

ArticleContemporary clinical trials2025

The TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) trial: design and baseline characteristics of participants.

Ellen M Mowry, Peiqing Qian, William Meador, Sharon Lynch, Ram Narayan, Aimee Borazanci, Derrick Robertson, Sara Qureshi, Jennifer Graves, Jason Silversteen and 26 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Observational
  2. Article
  3. Review
  4. Commentary: The Multiple Sclerosis Controversy: Is It Escalation or Induction High Efficacy?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors.

Ellen M MowryJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States. Electronic address: emowry1@jhmi.edu.
Peiqing QianSwedish Neuroscience Institute, 1600 E Jefferson Street, Seattle, WA 98122, United States.
William MeadorUniversity of Alabama at Birmingham, Department of Neurology, 1720 7th Ave S, Birmingham, AL 35294, United States.
Sharon LynchUniversity of Kansas Medical Center, Department of Neurology, 3901 Rainbow Blvd, Kansas City, KS 66160, United States.
Ram NarayanBarrow Neurological Institute, 240 W. Thomas Rd, Ste. 400, Phoenix, AZ 85013, United States.
Aimee BorazanciBarrow Neurological Institute, 240 W. Thomas Rd, Ste. 400, Phoenix, AZ 85013, United States.
Derrick RobertsonUniversity of South Florida, College of Medicine, Department of Neurology, 12901 Bruce B. Downs Blvd, MDC 55, Tampa, FL 33629, United States.
Sara QureshiBillings Clinic, 801 North 29th Street, Billings, MT 59101, United States.
Jennifer GravesUniversity of California, San Diego, Department of Neurosciences, 9452 Medical Center Drive, San Diego, CA 92037, United States.
Jason SilversteenChristianaCare MS Center, 200 Hygeia Drive, Newark, DE 19709, United States.
Megan EschGeisinger Medical Center, Neurosciences, 100 N Academy Drive, Danville, PA 17822, United States.
Leticia TornesUniversity of Miami, 1150 NW 14th Street, Miami, FL 33136, United States.
Claire RileyColumbia University Medical Center, Department of Neurology, Multiple Sclerosis Center, 710 W 168th St., New York, NY 10032, United States.
Marwa KaiseyCedars Sinai Medical Center, Department of Neurology, 127 S. San Vicente Blvd, Los Angeles, CA 90048, United States.
Nancy SicotteCedars Sinai Medical Center, Department of Neurology, 127 S. San Vicente Blvd, Los Angeles, CA 90048, United States.
Siddharama PawateVanderbilt University Medical Center, MS Center, 3810 Bedford Ave, Nashville, TN 27215, United States.
Tirisham GyangUniversity of Florida, Department of Neurology, 1149 Newell Dr, Gainesville, FL 32611, United States; The Ohio State University, Department of Neurology, 395 W. 12th Ave., 7th Floor, Columbus, OH 43210, United States(2).
Torge RempeUniversity of Florida, Department of Neurology, 1149 Newell Dr, Gainesville, FL 32611, United States.
Ahmed Z ObeidatMedical College of Wisconsin, Department of Neurology, 8701 Watertown Plank Road, Milwaukee, WI 53226, United States.
Geeta GaneshNorton Medical Group, Hussung Family MS Center, 3991 Dutchmans Lane Suite 310, Louisville, KY 40207, United States.
Lana Zhovtis RyersonNew York University Langone Health, Department of Neurology, 240 East 38th Street, 13th Floor, New York, NY 10016, United States; Hackensack Meridian Health JSUMC Multiple Sclerosis Center, 1945 Route 33, Neptune, NJ 07753, United States(2).
Tyler SmithNew York University Langone Health, Department of Neurology, 240 East 38th Street, 13th Floor, New York, NY 10016, United States.
John RoseUniversity of Utah, Department of Neurology, 729 Arapeen Drive, Salt Lake City, UT 84108, United States.
Aaron CarassJohns Hopkins University, Electrical and Computer Engineering, 3400 N Charles St, Baltimore, MD 21218, United States.
Ornusa ChalayonJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Mason Kruse-HoyerJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Monilola SalamiJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Amy LiuJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Blake DeweyJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Jacob M ChenJohns Hopkins University Whiting School of Engineering, 3400 N Charles St, Baltimore, MD 21218, United States.
Elizabeth OgburnJohns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205, United States.
Carolyn KochJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Jerry PrinceJohns Hopkins University, Electrical and Computer Engineering, 3400 N Charles St, Baltimore, MD 21218, United States.
Sandra D CassardJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
Scott D NewsomeJohns Hopkins University School of Medicine, Department of Neurology, 600 N. Wolfe Street, Baltimore, MD 21287, United States.
TREAT-MS Trial Team

Funding

Resolution Enhancement and Contrast Harmonization for MR NeuroimagingR01EB036013 · NIBIB · JOHNS HOPKINS UNIVERSITY · PI Jerry L Prince · 2025 to 2026
$920k
NIBIB NIH HHS R01 EB036013
6 · The paper itself

Abstract

backgroundWhether early use of higher-efficacy disease-modifying therapy (DMT) reduces later risk of disability in multiple sclerosis (MS) has not been studied as a prospective treatment strategy. Herein, we describe the TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial design and provide the baseline characteristics of the enrolled population.

methodsTREAT-MS is a pragmatic, randomized, rater-blinded trial of DMT strategies in treatment-naive people aged 18-60 years with relapsing-remitting MS (RRMS). Participants were randomized (1:1, stratified by site and long-term disability risk classification) to one of two treatment strategies: higher-efficacy or traditional DMT; the specific DMT within the assigned strategy was chosen by the clinician/patient pair. Participants could switch DMT for breakthrough disease occurring after 6 months on DMT. The primary outcome is sustained worsening of the Expanded Disability Status Scale (EDSS)-plus, a composite endpoint that includes the EDSS and the timed 25-ft walk and 9-hole peg tests.

resultsTREAT-MS includes 900 people with the following baseline characteristics: mean age 36 ± 10 years; 629 (70 %) female gender; 648 (72 %) white, 168 (19 %) Black/African American race, and 105 (12 %) Hispanic or Latino. Mean time since MS symptom onset was 2.6 (± 4.5) years, and mean EDSS score was 2.5 (± 1.3).

conclusionTREAT-MS seeks to address how early DMT strategy influences MS disability and related outcomes. The results will be generalizable to future individuals newly diagnosed with RRMS who, with their clinicians, will be able to use them to make data-driven DMT decisions about how to maximize their intermediate-term function.

Indexed as

Multiple Sclerosis, Relapsing-RemittingAdolescentAdultDisability EvaluationDisease ProgressionFemaleHumansMaleMiddle AgedPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignYoung AdultDisabilityDisease-modifying therapyMultiple sclerosisRandomized controlled trialTherapeutic strategy

Identifiers

PMID41135813
PMCPMC12951411

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.