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Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (TREAT-MS)

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ClinicalTrials.gov Identifier: NCT03500328
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Other: Early Aggressive Therapy or Traditional Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early Aggressive Therapy

Higher efficacy disease-modifying therapy (Early Aggressive Therapy) for treatment of multiple sclerosis

Early Aggressive Therapy choices and maximum allowable doses:

  • Natalizumab (Tysabri), 300 mg intravenously (IV) every 4 weeks
  • Alemtuzumab (Lemtrada), 12 mg IV daily for 5 days; 1 year later: 12 mg IV daily for 3 days
  • Ocrelizumab (Ocrevus), 300 mg IV every 2 weeks (for 2 doses) at initiation; subsequently, 600 mg IV every 6 months
  • Rituximab (Rituxan), 1000 mg IV every 2 weeks (for 2 doses); may repeat every 16-24 weeks
Other: Early Aggressive Therapy or Traditional Therapy
Participants will be stratified by whether they are at higher versus lower risk for long-term disability and then randomized 1:1 to a higher-efficacy versus a traditional, first-line disease-modifying therapy (DMT) class.

Active Comparator: Traditional Therapy

First-line disease-modifying therapy (Traditional Therapy) for treatment of multiple sclerosis

Traditional Therapy choices and maximum allowable doses:

  • Glatiramer acetate (Copaxone, Glatopa, and other generics), 20 mg subcutaneously (SC) daily, or 40 mg SC three times a week
  • Intramuscular interferon (Avonex), 30 mcg intramuscularly (IM) weekly
  • Subcutaneous interferon (Betaseron, Extavia, Rebif), 0.25 mg SC every other day (Betaseron, Extavia); 44 mcg SC three times a week (Rebif)
  • Pegylated interferon (Plegridy), 125 mcg SC every 14 days
  • Teriflunomide (Aubagio), 14 mg orally (PO) daily
  • Dimethyl fumarate (Tecfidera), 240 mg PO twice a day
  • Fingolimod (Gilenya), 0.5 mg PO daily
Other: Early Aggressive Therapy or Traditional Therapy
Participants will be stratified by whether they are at higher versus lower risk for long-term disability and then randomized 1:1 to a higher-efficacy versus a traditional, first-line disease-modifying therapy (DMT) class.




Primary Outcome Measures :
  1. Time to sustained disability progression [ Time Frame: From date of randomization until the date of first documented sustained disability progression, up to 48 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 > 1.0 point if baseline EDSS is < 5.5 or of > 0.5 if baseline EDSS is > 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.


Secondary Outcome Measures :
  1. Patient-Determined Disease Steps (PDDS) [ Time Frame: up to 54 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).

  2. Multiple Sclerosis Functional Composite (MSFC) Composite Score [ Time Frame: up to 48 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.

  3. Timed 25 Foot Walk Test [ Time Frame: up to 48 months ]
    Time taken to complete the timed 25 foot walk test, measured twice in units of seconds, will be averaged and evaluated.

  4. Nine-hole Peg Test [ Time Frame: up to 48 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.

  5. Paced Auditory Serial Addition Test (PASAT) [ Time Frame: up to 48 months ]
    The paced auditory serial addition test that measures processing speed will be administered once; number and percent correct will be evaluated.

  6. Low contrast visual acuity [ Time Frame: up to 48 months ]
    Low-contrast letter acuity (binocular, 2.5% contrast Sloan charts)

  7. Patient-reported incomplete relapse recovery [ Time Frame: up to 48 months ]
    Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on patient self-report.

  8. Neurologic exam-based incomplete relapse recovery [ Time Frame: up to 48 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).

  9. Cognition using Symbol Digit Modality Test (SDMT) [ Time Frame: up to 48 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.

  10. Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: up to 48 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.

  11. Quality of Life in Neurological Disorders (Neuro-QoL): Anxiety Subscale [ Time Frame: up to 48 months ]
    The Anxiety Subscale of Neuro-QoL will be administered as an electronic PRO.

  12. Quality of Life in Neurological Disorders (Neuro-QoL): Depression Subscale [ Time Frame: up to 48 months ]
    The Depression Subscale of Neuro-QoL will be administered as an electronic PRO.

  13. Quality of Life in Neurological Disorders (Neuro-QoL): Fatigue Subscale [ Time Frame: up to 48 months ]
    The Fatigue Subscale of Neuro-QoL will be administered as an electronic PRO.

  14. Quality of Life in Neurological Disorders (Neuro-QoL): Upper Extremity Function [ Time Frame: up to 48 months ]
    The Upper Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.

  15. Quality of Life in Neurological Disorders (Neuro-QoL): Lower Extremity Function [ Time Frame: up to 48 months ]
    The Lower Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.

  16. Quality of Life in Neurological Disorders (Neuro-QoL): Cognitive Function [ Time Frame: up to 48 months ]
    The Cognitive Function Subscale of Neuro-QoL will be administered as an electronic PRO.

  17. Quality of Life in Neurological Disorders (Neuro-QoL): Positive Affect/Well-being [ Time Frame: up to 48 months ]
    The Positive Affect/Well-being Subscale of Neuro-QoL will be administered as an electronic PRO.

  18. Quality of Life in Neurological Disorders (Neuro-QoL): Sleep Disturbance [ Time Frame: up to 48 months ]
    The Sleep Disturbance Subscale of Neuro-QoL will be administered as an electronic PRO.

  19. Quality of Life in Neurological Disorders (Neuro-QoL): Ability to Participate in Social Roles and Activities [ Time Frame: up to 48 months ]
    The Ability to Participate in Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.

  20. Quality of Life in Neurological Disorders (Neuro-QoL): Satisfaction with Social Roles and Activities [ Time Frame: up to 48 months ]
    The Satisfaction with Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.

  21. Quality of Life in Neurological Disorders (Neuro-QoL): Stigma [ Time Frame: up to 48 months ]
    The Stigma Subscale of Neuro-QoL will be administered as an electronic PRO.

  22. Employment status [ Time Frame: up to 48 months ]
    The incidence of change in employment to "disabled" or "looking for work, unemployed," will be evaluated for all participants through an electronic PRO.

  23. Marital status [ Time Frame: up to 48 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.

  24. Serious Adverse Events (SAEs) [ Time Frame: up to 48 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)

  25. Adverse event resulting in a decision to change disease-modifying therapy [ Time Frame: up to 48 months ]
    Adverse events meaningful enough to lead to medication discontinuation


Other Outcome Measures:
  1. Brain Magnetic Resonance Imaging (MRI) evidence of neurodegeneration [ Time Frame: From 6 months after starting 1st therapy up to 48 months after randomization ]
    Changes in brain MRI measures of neurodegeneration, including whole brain and normalized gray matter volumes, cortical thickness, subcortical gray matter compartment volumes, and measures of T2 lesion burden.

  2. Number of relapses [ Time Frame: up to 48 months ]
    The number of relapses (new or worsening neurologic symptoms lasting for 24 hours or more in the absence of fever).

  3. Number of new brain lesions on MRI [ Time Frame: up to 48 months ]
    The number of new/enlarging T2-weighted hyperintense lesions and T1-weighted hypointense lesions will be quantified on each MRI scan

  4. Retinal layer thickness by Optical Coherence Tomography (OCT) [ Time Frame: up to 48 months ]
    Retinal nerve fiber layer and ganglion cell/inner plexiform thickness will be evaluated among patients at centers and offices with access to OCT as standard of care

  5. Number of new medications, escalated dosage of medications, and non-pharmacologic interventions for MS-related symptoms [ Time Frame: up to 48 months ]
    As an exploratory outcome, the number of newly-prescribed or dose-escalated medications used for treating MS symptoms (including pain, weakness, numbness/tingling, trouble walking, cognitive problems, fatigue, depression, anxiety, visual dysfunction, spasticity, vertigo, or bladder/bowel/sexual dysfunction) during the trial will be evaluated using the electronic health record. In addition, non-pharmacologic interventions (and referrals to other healthcare providers) for symptom management will also be captured.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500328


Contacts
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Contact: Sandra Cassard, ScD 443-287-4353 scassar1@jhmi.edu
Contact: Madiha Qutab, MS 410-614-9201 mqutab1@jhmi.edu

  Hide Study Locations
Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Christie Lowe    205-996-2980    christielowe@uabmc.edu   
Contact: Kerry Howard, RN, MSCN    205-934-1885    kdhoward@uabmc.edu   
Principal Investigator: William Meador, MD         
United States, Arizona
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Stacey Lent, CCRC    602-406-6291    Stacey.Lent@dignityhealth.org   
Principal Investigator: Ram Narayan, MD         
United States, California
Dignity Health Medical Foundation Recruiting
Carmichael, California, United States, 95608
Contact: Lucy Ng, MA, CCRC    916-536-2048    Lucy.Ng@dignityhealth.org   
Principal Investigator: Sabeen Lulu, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Cedars-Sinai MS Research Coordinator    310-423-4008    GroupNeurologyMSProgramResearch@cshs.org   
Principal Investigator: Nancy Sicotte, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: William Swearingen    310-794-3329    WSwearingen@mednet.ucla.edu   
Principal Investigator: Barbara Giesser, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92037
Contact: Jacqueline Alim    858-246-2905    jaalim@ucsd.edu   
Principal Investigator: Jennifer S. Graves, MD, PhD, MAS         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Nisha R Revirajan, CCRC    415-502-7220    NishaRaj.Revirajan@ucsf.edu   
Principal Investigator: Emmanuelle L Waubant, MD, PhD         
United States, Delaware
Christiana Care Health Services, Inc. Recruiting
Newark, Delaware, United States, 19713
Contact: Kathleen Greenbaum, MSN, RN, CCRC, CDE    302-623-3844    kgreenbaum@christianacare.org   
Principal Investigator: Jason Silversteen, DO         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Alexis Ahmad    202-444-2658    Asc73@georgetown.edu   
Principal Investigator: Carlo Tornatore, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Victoria Hope    352-294-8948    Victoria.Hope@neurology.ufl.edu   
Contact: Jennifer Steshyn    352-273-9022    Jennifer.Steshyn@neurology.ufl.edu   
Principal Investigator: Tirisham Gyang, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Yanet Babcock    305-243-1088    ybabcock@med.miami.edu   
Contact: Gloria Rodriguez    305-243-8052    g.rodriguez8@med.miami.edu   
Principal Investigator: Leticia Tornes, MD         
University of South Florida Health Recruiting
Tampa, Florida, United States, 33612
Contact: Angela Aungst    813-974-6378    aaungst@health.usf.edu   
Principal Investigator: Derrick Robertson, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Rosemarie R. Baligod, RN, BSN    312-942-2728    Rosemarie_Baligod@rush.edu   
Principal Investigator: Michael Ko, MD         
United States, Kansas
The University of Kansas Medical Center (KUMC) Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lisa Schmidt, LPN    913-588-3968    LSCHMIDT@kumc.edu   
Principal Investigator: Sharon Lynch, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Angela Siegwald    502-852-2043    Angela.siegwald@louisville.edu   
Principal Investigator: Kristi Nord, MD         
Norton Neurology MS Services Recruiting
Louisville, Kentucky, United States, 40207
Contact: Deborah Lockridge, RN, BSN, MSCN, CCRC    502-899-6417    Deborah.Lockridge@nortonhealthcare.org   
Principal Investigator: Geeta A Ganesh, MD, MPH         
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kerry Naunton, RN, MSCN, CCRC    410-328-1885    knaunton@som.umaryland.edu   
Principal Investigator: Daniel Harrison, MD         
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jen Chalayon, MD       TREATMS@jhmi.edu   
Principal Investigator: Ellen M Mowry, MD, MCR         
Principal Investigator: Scott D Newsome, DO         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Russo    617-726-7531    awrusso@mgh.harvard.edu   
Contact: Sarah Rapaport       srapaport@mgh.harvard.edu   
Principal Investigator: Eric C. Klawiter, MD, MSc         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Shaukat Soofi, RN, BSc    774-441-7695    Shaukat.Soofi@umassmed.edu   
Principal Investigator: Peter Riskind, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Katie Dunlay    507-538-5418    Dunlay.Katie@mayo.edu   
Contact: Jessica Sagen, MA    507-538-3761    Sagen.Jessica@mayo.edu   
Principal Investigator: W. Oliver Tobin, MB, BCh, BAO, PhD         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Amy Harmala, LPN    406-435-8490    aharmala@billingsclinic.org   
Contact: Kathy Wilkinson, RN, BSN, OCN, CCRP    406-435-7415    kwilkinson@billingsclinic.org   
Principal Investigator: Sara Qureshi, MD         
Advanced Neurology Specialists Recruiting
Great Falls, Montana, United States, 59405
Contact: Laura Armstrong, LPN    406-455-2583    laurafarmstrong@ansresearch.com   
Principal Investigator: Dennis Dietrich, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lee Ifhar, MSc    551-996-8100    Lee.Ifhar@hackensackmeridian.org   
Principal Investigator: Krupa Pandey, MD         
RWJBarnabas Health Multiple Sclerosis Comprehensive Care Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Isaac Lipsky    973-322-7073    Isaac.Lipsky@rwjbh.org   
Principal Investigator: Matthew Tremblay, MD, PhD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Dunia Gragui    929-455-5086    Dunia.Gragui@nyulangone.org   
Contact: Lupe Zuniga-Estrada    929-455-5087    Guadelupe.Zuniga-Estrada@nyulangone.edu   
Principal Investigator: Lana Zhovtis Ryerson, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kaho Onomichi    212-305-9155    ko2418@cumc.columbia.edu   
Principal Investigator: Claire Riley, MD         
University of Rochester Medical Center Active, not recruiting
Rochester, New York, United States, 14642
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794-8121
Contact: Jessica Lamb    631-444-8068    Jessica.lamb@stonybrookmedicine.edu   
Principal Investigator: Patricia Coyle, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Molly Winters, BSc, CCRP    513-558-0269    winteme@ucmail.uc.edu   
Contact: Ashley Fisher, CCRC    513-558-4874    Ashley.fisher@uc.edu   
Principal Investigator: Elizabeth Dragan, MD         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Fama Diallo       Fatimata.Diallo@ohiohealth.com   
Principal Investigator: Aaron Boster, MD         
United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Micki Moore    405-271-6241    micki-drake@omrf.org   
Principal Investigator: Gabriel Pardo, MD         
United States, Oregon
Providence Health and Services - Oregon Recruiting
Portland, Oregon, United States, 97225
Contact: Hillary Frey    503-216-0627    Hillary.Frey@providence.org   
Principal Investigator: Kiren Kresa-Reahl, MD         
United States, Pennsylvania
Geisinger Clinic Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Chelsie Derr    570-214-2432    cmderr1@geisinger.edu   
Contact: Angela Whitmire    570-214-2834    awhitmire@geisinger.edu   
Principal Investigator: Megan Esch, MD         
Allegheny Health Network Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Mary Fetter    412-359-4856    Mary.Fetter@ahn.org   
Principal Investigator: Troy Desai, MD         
United States, Tennessee
Vanderbilt Comprehensive MS Center Recruiting
Nashville, Tennessee, United States, 37215
Contact: Jennifer Scott, RN    615-322-4085    jennifer.scott@vumc.edu   
Principal Investigator: Siddharama Pawate, MD         
United States, Texas
Baylor Scott and White Health Recruiting
Dallas, Texas, United States, 75246
Contact: Rowan Teboh, RN, MSN    214-818-2529    Rowan.Teboh1@BSWHealth.org   
Contact: Dianna Robinson, LVN, CCRC    214-818-2526    Dianna.Robinson@BSWHealth.org   
Principal Investigator: Annette F Okai, MD         
Central Texas Neurology Consultants Recruiting
Round Rock, Texas, United States, 78681
Contact: Juan Ramirez    512-218-1222 ext 213    j.ramirez@ctncpa.org   
Contact: Lori Mayer, DNP    512-218-1222 ext 205    lorimayerdnp@gmail.com   
Principal Investigator: Edward J Fox, MD, PhD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Ka Ho Wong    801-585-8021    Ka-ho.wong@hsc.utah.edu   
Principal Investigator: John W Rose, MD         
United States, Vermont
The University of Vermont and State Agricultural College Recruiting
Burlington, Vermont, United States, 05405
Contact: Jane Low, MPA, CCRC    802-847-0983    Jane.Low@uvmhealth.org   
Principal Investigator: Andrew Solomon, MD         
United States, Virginia
Neurology Consultants of Tidewater Recruiting
Norfolk, Virginia, United States, 23502
Contact: Veda Byrd, MPH    757-226-0655    vbyrd@mcrmed.com   
Principal Investigator: Ingrid Loma-Miller, MD         
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States, 98122
Contact: Yuriko Courtney, CCRC    206-320-2647    Yuriko.Courtney@swedish.org   
Principal Investigator: Peiqing Qian, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98133
Contact: Elisa McGee    206-598-9260    emcgee@uw.edu   
Principal Investigator: Gloria von Geldern, MD         
Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Ellen M. Mowry, MD, MCR Johns Hopkins University
Principal Investigator: Scott D. Newsome, DO Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03500328     History of Changes
Other Study ID Numbers: IRB00143534
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases