ACTIVE_NOT_RECRUITING

Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis

Quick Facts

Study Start:2018-05-02
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03500328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-60 years
  2. * Meets 2017 McDonald criteria for relapsing-remitting MS \[patients with clinically isolated syndrome (CIS) are not eligible\]
  3. * 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
  4. * HIV negative
  5. * 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
  1. * Prior treatment with rituximab, ocrelizumab, ofatumumab, alemtuzumab, mitoxantrone or cladribine
  2. * Prior treatment with any other MS DMT for more than 6 months
  3. * Prior treatment with experimental aggressive therapies (e.g., T-cell vaccine, total lymphoid radiation, stem cells)
  4. * Treatment with teriflunomide within past 2 years (even for ≤ 6 months), unless rapid wash out done (i.e., with cholestyramine or activated charcoal)
  5. * Treatment in the past 6 months with any MS DMT
  6. * Prior treatment with any other investigational immune-modulating /suppressing drug for MS not listed above
  7. * Pregnant or breast-feeding
  8. * Women of child-bearing age who are planning or strongly considering conception during the study time frame

Contacts and Locations

Principal Investigator

Ellen M. Mowry, MD, MCR
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Scott D. Newsome, DO
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Ellen M. Mowry, MD, MCR, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Scott D. Newsome, DO, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-02
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2018-05-02
Study Completion Date2026-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Multiple Sclerosis, Relapsing-Remitting