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Tradycyjna kontra wczesna agresywna terapia dla próby stwardnienia rozsianego (TREAT-MS)

22 września 2026 zaktualizowane przez: Johns Hopkins University

Pragmatyczna próba oceny średniookresowych efektów wczesnej, agresywnej terapii przeciw eskalacji u osób ze stwardnieniem rozsianym

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Hypotheses/Objectives: The main hypothesis is that intermediate-term disability will be reduced by earlier use of higher-efficacy medications. Additional objectives include a) evaluating the magnitude of the treatment effect in patients deemed to be at higher risk versus lower risk of longer-term disability (we hypothesize that the effect size will be greater in the former group) and b) evaluating if, among those without indications of a high risk of longer-term disability, breakthrough disease can be successfully managed by switching to a different first-line therapy or if escalation is required at that time (we hypothesize that switching to a higher-efficacy therapy will be more effective in preventing disability in this group).

There is a great unmet need to identify the most appropriate treatment strategy for people with MS, especially early in the disease course when it may be possible to maximize an individual's chance for preventing long-term disability. There is a paucity of evidence-based guidelines to help clinicians, patients, and payers determine which treatment strategy is best for an individual with MS. Making treatment decisions is a daunting task, and the individualized benefit-risk assessment becomes increasingly difficult as new therapies emerge. Without the availability of direct comparative trials, clinicians and patients are forced to scrutinize observational studies that only provide basic insights into what may be the best treatment path moving forward. It is equally challenging to define what constitutes a suboptimal response to a DMT for an individual patient. Clinicians lack guidance on when to switch therapies and whether to consider a different first-line or if clinicians should escalate immediately to higher-efficacy therapies, so further consensus is needed to determine the optimal time to switch therapies and escalate therapy if an individual is on a first-line therapy from the start. The TREAT-MS trial will help inform patients and the broader health care 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 occurs, is warranted. In addition, this study may help identify specific patient populations and/or short-term clinical and paraclinical biomarkers that are strongly predictive of long-term disability that can ensue from MS.

Accrual of sustained disability is the most feared complication for people with MS, and the patient's own perception of their well-being or ill-being has a profound impact on their quality of life. The heterogeneity and unpredictability of MS, along with lack of agreed upon treatment guidelines, augments this fear, leading to a significant negative impact on quality of life. Even patients who are deemed to have "mild" MS experience a significant negative impact on their health-related quality of life that is similar in magnitude to what patients with other severe chronic conditions (i.e., congestive heart failure and chronic obstructive pulmonary disease) report. 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 (e.g. slowing disability progression), the TREAT-MS trial will capture several important and meaningful PROs that will shed light on what treatment strategies may be the best from a patient-centered perspective.

COVID-19 Related Substudy:

Since early 2020, the coronavirus disease 2019 (COVID-19) pandemic has caused clinical care and research disruptions nationwide, including for patients enrolled in the TREAT-MS trial. Many patients with MS, as well as their clinicians, are fearful that MS or the MS therapy they are using may increase the risk or severity of COVID-19 infection. Whether a person with early MS is more likely to experience more severe COVID-19 if treated with a higher-efficacy therapy is not known. Further, whether COVID-19-induced disruptions in therapy or other clinical care increase MS disease activity or MS symptoms is not clear but is relevant, particularly since greater MS activity in the early therapeutic course is associated in observational studies with worse long-term outcomes. Moreover, it is unclear if pre-pandemic anxiety and depression, common comorbidities in people with MS, contribute to decisions to delay care, overall or differently depending on therapeutic strategy (higher-efficacy vs. traditional). TREAT-MS provides an optimal cohort in which to investigate the effect of the COVID-19 pandemic on MS outcomes.

COVID-19 Substudy Aim 1. To evaluate if patients enrolled in TREAT-MS delayed or altered their disease-modifying therapy schedule or other MS care, and whether such alterations are associated with a greater degree of breakthrough inflammatory disease activity or the development of new (or worsening baseline) MS symptoms.

COVID-19 Substudy Aim 2: To evaluate if patients with MS treated with higher-efficacy, versus traditional, therapies differ in the risk of severe COVID-19 infection, defined as requiring hospitalization (with or without intubation) or mortality due to COVID-19.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

900

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35233
        • University of Alabama at Birmingham
      • Mobile, Alabama, Stany Zjednoczone, 36604
        • The University of South Alabama
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85013
        • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
    • California
      • Carmichael, California, Stany Zjednoczone, 95608
        • CommonSpirit Health Research Institute
      • Los Angeles, California, Stany Zjednoczone, 90095
        • University of California, Los Angeles
      • Los Angeles, California, Stany Zjednoczone, 90048
        • Cedars-Sinai Medical Center
      • San Diego, California, Stany Zjednoczone, 92037
        • University of California, San Diego
      • San Francisco, California, Stany Zjednoczone, 94158
        • University of California, San Francisco
    • Delaware
      • Newark, Delaware, Stany Zjednoczone, 19713
        • Christiana Care Health Services, Inc.
    • District of Columbia
      • Washington D.C., District of Columbia, Stany Zjednoczone, 20007
        • Georgetown University
    • Florida
      • Gainesville, Florida, Stany Zjednoczone, 32611
        • University of Florida
      • Miami, Florida, Stany Zjednoczone, 33136
        • University of Miami
      • Tampa, Florida, Stany Zjednoczone, 33612
        • University of South Florida Health
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60612
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, Stany Zjednoczone, 66160
        • The University of Kansas Medical Center (KUMC)
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40207
        • Norton Neurology MS Services
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21287
        • The Johns Hopkins Hospital
      • Baltimore, Maryland, Stany Zjednoczone, 21201
        • University of Maryland, Baltimore
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital
      • Worcester, Massachusetts, Stany Zjednoczone, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • University of Michigan
      • Detroit, Michigan, Stany Zjednoczone, 48201
        • Wayne State University
    • Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Mayo Clinic
    • Montana
      • Billings, Montana, Stany Zjednoczone, 59101
        • Billings Clinic
      • Great Falls, Montana, Stany Zjednoczone, 59405
        • Advanced Neurology Specialists
    • Nebraska
      • Omaha, Nebraska, Stany Zjednoczone, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, Stany Zjednoczone, 10032
        • Columbia University Medical Center
      • New York, New York, Stany Zjednoczone, 10016
        • New York University School of Medicine
      • New York, New York, Stany Zjednoczone, 10029
        • Icahn School of Medicine at Mount Sinai
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45219
        • University of Cincinnati
      • Columbus, Ohio, Stany Zjednoczone, 43214
        • OhioHealth Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
        • Oklahoma Medical Research Foundation
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97225
        • Providence Health and Services - Oregon
    • Pennsylvania
      • Danville, Pennsylvania, Stany Zjednoczone, 17822
        • Geisinger Clinic
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
        • Allegheny Health Network Research Institute
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37215
        • Vanderbilt Comprehensive MS Center
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75246
        • Baylor Scott and White Health
      • Dallas, Texas, Stany Zjednoczone, 75390-8806
        • University of Texas Southwestern Medical Center
      • Round Rock, Texas, Stany Zjednoczone, 78681
        • Central Texas Neurology Consultants
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84108
        • University of Utah
    • Vermont
      • Burlington, Vermont, Stany Zjednoczone, 05405
        • The University of Vermont and State Agricultural College
    • Virginia
      • Christiansburg, Virginia, Stany Zjednoczone, 24073
        • Blacksburg Neurology
      • Norfolk, Virginia, Stany Zjednoczone, 23502
        • Neurology Consultants of Tidewater
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98122
        • Swedish Health Services
      • Seattle, Washington, Stany Zjednoczone, 98133
        • University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, Stany Zjednoczone, 53226
        • Medical College of Wisconsin

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 60 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Aged 18-60 years
  • Meets 2017 McDonald criteria for relapsing-remitting MS [patients with clinically isolated syndrome (CIS) are not eligible]
  • Must be EITHER John Cunningham (JC) virus antibody negative or low positive (index antibody titer <0.9), OR negative for: Hepatitis B and C, tuberculosis
  • HIV negative
  • No chemotherapy in past year; if patient has prior history of chemotherapy or malignancy, documentation in chart explaining why potential risks of higher-efficacy therapy are justified

Exclusion Criteria:

  • Prior treatment with rituximab, ocrelizumab, ofatumumab, alemtuzumab, mitoxantrone or cladribine
  • Prior treatment with any other MS DMT for more than 6 months
  • Prior treatment with experimental aggressive therapies (e.g., T-cell vaccine, total lymphoid radiation, stem cells)
  • Treatment with teriflunomide within past 2 years (even for ≤ 6 months), unless rapid wash out done (i.e., with cholestyramine or activated charcoal)
  • Treatment in the past 6 months with any MS DMT
  • Prior treatment with any other investigational immune-modulating /suppressing drug for MS not listed above
  • Pregnant or breast-feeding
  • Women of child-bearing age who are planning or strongly considering conception during the study time frame

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Early Aggressive Therapy

Early Aggressive Therapy choices and maximum allowable doses:

  • Natalizumab/natalizumab-sztn (Tysabri/Tyruko), 300 mg IV q 4 wks
  • Alemtuzumab (Lemtrada), 12 mg IV daily (QD) for 5 days; 1 yr later: 12 mg IV QD for 3 days
  • Ocrelizumab (Ocrevus), 300 mg IV every 2 wks (for 2 doses) at initiation; 600 mg IV q 6 mths
  • Rituximab/rituximab biosimilars (Rituxan/Riabni/Truxima/Ruxience), 1000 mg IV every 2 wks (for 2 doses); may repeat q 16-24 wks
  • Cladribine (Mavenclad), 3.5 mg per kg body wt orally divided into 2 yrly tmt courses (1.75 mg per kg body wt each yr); yrly tmt course divided into 2 tmt cycles; administer cycle dose as 1-2 tablets QD over 4-5 days
  • Ofatumumab (Kesimpta), 20 mg SC wkly for wks 0, 1 and 2; 20 mg subcutaneously (SC) mthly starting at wk 4
  • Ublituximab-xiiy (Briumvi), 150 mg IV (1st dose); 450 mg IV 2 wks after first dose; 450 mg IV q 24 wks
  • Ocrelizumab and hyaluronidase-ocsq (Ocrevus Zunovo), 920 mg ocrelizumab and 23,000 U hyaluronidase SC q 6 months
Inny: Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq

Early Aggressive Therapy

Inne nazwy:
  • Tysabri, Lemtrada, Ocrevus, Rituxan/Riabni/Truxima/Ruxience, Mavenclad, Kesimpta, Briumvi, Ocrevus Zunovo
Aktywny komparator: Traditional Therapy

Traditional Therapy choices and maximum allowable doses:

  • Glatiramer acetate (Copaxone, Glatopa, and other generics), 20 mg SC daily, or 40 mg SC 3 times a wk
  • Intramuscular (IM) interferon (Avonex), 30 mcg IM weekly
  • SC interferon (Betaseron, Extavia, Rebif), 0.25 mg SC every other day (Betaseron, Extavia); 44 mcg SC 3 times a wk (Rebif)
  • Pegylated interferon (Plegridy), 125 mcg SC every 14 days
  • Teriflunomide (Aubagio), 14 mg PO QD
  • Dimethyl fumarate (Tecfidera and generics), 240 mg PO twice a day (BID)
  • Diroximel fumarate (Vumerity), 462 mg PO BID
  • Monomethyl fumarate (Bafiertam), 190 mg PO BID
  • Fingolimod (Gilenya and generics), 0.5 mg PO QD
  • Siponimod (Mayzent), 1 mg PO QD or 2 mg PO QD
  • Ozanimod (Zeposia), 0.92 mg PO QD
  • Ponesimod (Ponvory), 20 mg PO QD
  • Fingolimod ODT (Tascenso), 0.25 mg PO QD if <=40 kg; 0.5 mg PO QD if > 40 kg
Inny: Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod

Traditional Therapy

Inne nazwy:
  • Copaxone, Glatopa, Avonex, Betaseron, Extavia, Rebif, Plegridy, Aubagio, Tecfidera, Vumerity, Bafiertam, Gilenya, Mayzent, Zeposia, Ponvory, Tascenso

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to sustained disability progression
Ramy czasowe: From date of randomization until the date of first documented sustained disability progression, up to 99 months

Time to sustained disability progression is measured by the Expanded Disability Status Scale plus (EDSS+): a composite endpoint that includes EDSS change (change at any 6 month time point of > or = 1.0 point if baseline EDSS is < or = 5.5 or of > or = 0.5 if baseline EDSS is > or = 6.0, that is sustained 6 months later) OR 20% worsening on either of two specific components of the Multiple Sclerosis Functional Composite (MSFC), the timed 25-foot walk test (T25FWT) and the nine hole peg test (9HPT) that is sustained 6 months later.
From date of randomization until the date of first documented sustained disability progression, up to 99 months
Change in Overall Burden of MS
Ramy czasowe: up to 48 weeks from enrollment into COVID-19 related substudy

The change in overall burden of MS will be defined for the COVID-19 related substudy as the occurrence of breakthrough disease (relapses or new MRI activity) or the development of new (or worsening baseline) MS symptoms, which are (for TREAT-MS) and will continue to be (during the substudy) documented at clinical visits, whether in-person or on tele-visits.
up to 48 weeks from enrollment into COVID-19 related substudy

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient-Determined Disease Steps (PDDS)
Ramy czasowe: up to 99 months

PDDS is a self-assessment scale of disability due to MS on a scale from 0 to 8 and will be administered as an electronic patient-reported outcome (PRO).
up to 99 months
Multiple Sclerosis Functional Composite (MSFC) Composite Score
Ramy czasowe: up to 99 months

The MSFC consists of the timed 25 foot walk test, the 9-hole peg test, and the Paced Auditory Serial Addition Test (PASAT) and a composite MSFC z-score will be evaluated.
up to 99 months
Timed 25 Foot Walk Test
Ramy czasowe: up to 99 months

Time taken to complete the timed 25 foot walk test, measured twice in units of seconds, will be averaged and evaluated.
up to 99 months
Nine-hole Peg Test
Ramy czasowe: up to 99 months

Time taken to complete the nine-hole peg test, measured twice for each hand (dominant and non-dominant) in units of seconds, will be averaged for each hand and evaluated.
up to 99 months
Paced Auditory Serial Addition Test (PASAT)
Ramy czasowe: up to 99 months

The paced auditory serial addition test that measures processing speed will be administered once; number and percent correct will be evaluated.
up to 99 months
Low contrast visual acuity
Ramy czasowe: up to 99 months

Low-contrast letter acuity (binocular, 2.5% contrast Sloan charts)
up to 99 months
Patient-reported incomplete relapse recovery
Ramy czasowe: up to 99 months

Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on patient self-report.
up to 99 months
Neurologic exam-based incomplete relapse recovery
Ramy czasowe: up to 99 months

Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on neurologic examination (those who have increased Functional System scores, corresponding to the relapse symptoms, of 1.0 point or greater for at least 6 months after the relapse onset, without subsequent accrual of worsening in that same Functional System (e.g. more indicative of progression), will be considered to have incomplete relapse recovery).
up to 99 months
Cognition using Symbol Digit Modality Test (SDMT)
Ramy czasowe: up to 99 months

The SDMT is commonly used in MS to assess processing speed and will be administered orally and used to evaluate changes in cognition throughout the study.
up to 99 months
Multiple Sclerosis Impact Scale (MSIS-29)
Ramy czasowe: up to 99 months

The MSIS-29 will be used to evaluate the impact of MS on the participants and will be administered as an electronic PRO.Multiple Sclerosis Impact Scale (MSIS-29) is an instrument used for measuring the physical (20 items) and psychological (nine items) impact of multiple sclerosis.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Anxiety Subscale
Ramy czasowe: up to 99 months

The Anxiety Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Depression Subscale
Ramy czasowe: up to 99 months

The Depression Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Fatigue Subscale
Ramy czasowe: up to 99 months

The Fatigue Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Upper Extremity Function
Ramy czasowe: up to 99 months

The Upper Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Lower Extremity Function
Ramy czasowe: up to 99 months

The Lower Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Cognitive Function
Ramy czasowe: up to 99 months

The Cognitive Function Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Positive Affect/Well-being
Ramy czasowe: up to 99 months

The Positive Affect/Well-being Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Sleep Disturbance
Ramy czasowe: up to 99 months

The Sleep Disturbance Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Ability to Participate in Social Roles and Activities
Ramy czasowe: up to 99 months

The Ability to Participate in Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Satisfaction with Social Roles and Activities
Ramy czasowe: up to 99 months

The Satisfaction with Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Quality of Life in Neurological Disorders (Neuro-QoL): Stigma
Ramy czasowe: up to 99 months

The Stigma Subscale of Neuro-QoL will be administered as an electronic PRO.
up to 99 months
Employment status
Ramy czasowe: up to 99 months

The incidence of change in employment to "disabled" or "looking for work, unemployed," will be evaluated for all participants through an electronic PRO.
up to 99 months
Marital status
Ramy czasowe: up to 99 months

Incident divorce or separation, among those who previously were married or in a domestic partnership, will be evaluated for all participants through an electronic PRO.
up to 99 months
Serious Adverse Events (SAEs)
Ramy czasowe: up to 99 months

SAEs (clinically significant infections, malignancies, or the development of other serious comorbidities, as well as unplanned hospitalizations [for non-elective issues, excluding MS relapse] and death)
up to 99 months
Adverse event resulting in a decision to change disease-modifying therapy
Ramy czasowe: up to 99 months

Adverse events meaningful enough to lead to medication discontinuation
up to 99 months
Severe COVID-19 Infection
Ramy czasowe: up to 48 weeks from enrollment into COVID-19 related substudy

Severe COVID-19 infection will be defined as an outcome of "hospitalization or death" due to confirmed or suspected COVID-19 infection
up to 48 weeks from enrollment into COVID-19 related substudy

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Johns Hopkins University

Współpracownicy

Patient-Centered Outcomes Research Institute
National Multiple Sclerosis Society

Śledczy

  • Główny śledczy: Ellen M. Mowry, MD, MCR, Johns Hopkins University
  • Główny śledczy: Scott D. Newsome, DO, Johns Hopkins University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 maja 2018

Zakończenie podstawowe (Rzeczywisty)

31 lipca 2026

Ukończenie studiów (Rzeczywisty)

31 sierpnia 2026

Daty rejestracji na studia

Pierwszy przesłany

21 lutego 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 kwietnia 2018

Pierwszy wysłany (Rzeczywisty)

18 kwietnia 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00143534

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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