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Contemporary clinical trials · 2025

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

СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Mowry Ellen M, Qian Peiqing, Meador William, Lynch Sharon, Narayan Ram, Borazanci Aimee, Robertson Derrick, Qureshi Sara, Graves Jennifer, Silversteen Jason, Esch Megan, Tornes Leticia, Riley Claire, Kaisey Marwa, Sicotte Nancy, Pawate Siddharama, Gyang Tirisham, Rempe Torge, Obeidat Ahmed Z, Ganesh Geeta, Ryerson Lana Zhovtis, Smith Tyler, Rose John, Carass Aaron, Chalayon Ornusa, Kruse-Hoyer Mason, Salami Monilola, Liu Amy, Dewey Blake, Chen Jacob M, Ogburn Elizabeth, Koch Carolyn, Prince Jerry, Cassard Sandra D, Newsome Scott D, TREAT-MS Trial Team

Аннотация

BACKGROUND: Whether 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.

METHODS: TREAT-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.

RESULTS: TREAT-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).

CONCLUSION: TREAT-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.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты