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NCT03500328 · ClinicalTrials.gov registry record · NA

Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

A NA study of Multiple Sclerosis (Relapsing Remitting), sponsored by Johns Hopkins University.

Active
Registry status
NA
Development phase
900
Enrollment target
20
Study locations

NCT03500328 is a NA study of Multiple Sclerosis (Relapsing Remitting) that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 900 participants, above the 532-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (69% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT03500328, a NA study of Multiple Sclerosis (Relapsing Remitting), is active but no longer recruiting, sponsored by Johns Hopkins University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
900 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Multiple Sclerosis (Relapsing Remitting)

Interventions

  • OTHER Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq
  • OTHER Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod

Study Locations (20)

California

  • CommonSpirit Health Research Institute - Carmichael
  • Cedars-Sinai Medical Center - Los Angeles
  • University of California, Los Angeles - Los Angeles
  • University of California, San Diego - San Diego
  • University of California, San Francisco - San Francisco

Florida

  • University of Florida - Gainesville
  • University of Miami - Miami
  • University of South Florida Health - Tampa

Alabama

  • University of Alabama at Birmingham - Birmingham
  • The University of South Alabama - Mobile

Maryland

  • University of Maryland, Baltimore - Baltimore
  • The Johns Hopkins Hospital - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston
  • University of Massachusetts Medical School - Worcester

Arizona

  • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute - Phoenix

Delaware

  • Christiana Care Health Services, Inc. - Newark

District of Columbia

  • Georgetown University - Washington D.C.

Trial Details

FieldValue
Enrollment Target 900 participants
Start Date 2018-05-02
Est. Completion 2026-08-01
Phase NA

Sponsor

Johns Hopkins University

1,448 total trials

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What the Registry Record Tells You About NCT03500328

The ClinicalTrials.gov registry entry for NCT03500328 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 532-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (69% higher). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 2 interventions - of which Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq is the first listed.

NCT03500328 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT03500328 about?

NCT03500328 is a clinical study titled "Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial". 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 disa...

What is the current status of trial NCT03500328?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 900 participants. The study started on 2018-05-02. Estimated completion is 2026-08-01.

What conditions does trial NCT03500328 study?

This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting).

What interventions are being tested in trial NCT03500328?

The interventions under investigation include: Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq (OTHER), Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod (OTHER).

Who is sponsoring clinical trial NCT03500328?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03500328 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.