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Terapia tradizionale contro terapia aggressiva precoce per la prova della sclerosi multipla (TREAT-MS)

22 settembre 2026 aggiornato da: Johns Hopkins University

Uno studio pragmatico per valutare gli effetti a medio termine della terapia precoce, aggressiva rispetto all'escalation nelle persone con sclerosi multipla

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.

Panoramica dello studio

Stato

Completato

Condizioni

Sclerosi multipla, recidivante-remittente

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

900

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: 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	Altro: Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq Early Aggressive Therapy Altri nomi: Tysabri, Lemtrada, Ocrevus, Rituxan/Riabni/Truxima/Ruxience, Mavenclad, Kesimpta, Briumvi, Ocrevus Zunovo
Comparatore attivo: 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	Altro: Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod Traditional Therapy Altri nomi: Copaxone, Glatopa, Avonex, Betaseron, Extavia, Rebif, Plegridy, Aubagio, Tecfidera, Vumerity, Bafiertam, Gilenya, Mayzent, Zeposia, Ponvory, Tascenso

Gruppo di partecipanti / Arm

Intervento / Trattamento

Comparatore attivo: 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

Altro: Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq

Early Aggressive Therapy

Altri nomi:

Tysabri, Lemtrada, Ocrevus, Rituxan/Riabni/Truxima/Ruxience, Mavenclad, Kesimpta, Briumvi, Ocrevus Zunovo

Comparatore attivo: 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

Altro: Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod

Traditional Therapy

Altri nomi:

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Time to sustained disability progression Lasso di tempo: 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 Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Patient-Determined Disease Steps (PDDS) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: up to 99 months	Low-contrast letter acuity (binocular, 2.5% contrast Sloan charts)	up to 99 months
Patient-reported incomplete relapse recovery Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: up to 99 months	The Stigma Subscale of Neuro-QoL will be administered as an electronic PRO.	up to 99 months
Employment status Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: up to 99 months	Adverse events meaningful enough to lead to medication discontinuation	up to 99 months
Severe COVID-19 Infection Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Johns Hopkins University

Collaboratori

Patient-Centered Outcomes Research Institute

National Multiple Sclerosis Society

Investigatori

Investigatore principale: Ellen M. Mowry, MD, MCR, Johns Hopkins University
Investigatore principale: Scott D. Newsome, DO, Johns Hopkins University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Kwon S, Sillau S, Corboy JR, Nair KV, Carlson AM. Shifting patterns of multiple sclerosis treatment in a highly prevalent United States population. Ann Clin Transl Neurol. 2024 Jun;11(6):1526-1534. doi: 10.1002/acn3.52069. Epub 2024 Apr 23.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 maggio 2018

Completamento primario (Effettivo)

31 luglio 2026

Completamento dello studio (Effettivo)

31 agosto 2026

Date di iscrizione allo studio

Primo inviato

21 febbraio 2018

Primo inviato che soddisfa i criteri di controllo qualità

12 aprile 2018

Primo Inserito (Effettivo)

18 aprile 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

IRB00143534

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Terapia tradizionale contro terapia aggressiva precoce per la prova della sclerosi multipla (TREAT-MS)

Uno studio pragmatico per valutare gli effetti a medio termine della terapia precoce, aggressiva rispetto all'escalation nelle persone con sclerosi multipla

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Collaboratori

Investigatori

Pubblicazioni e link utili

Pubblicazioni generali

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti