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NCT04047628 · ClinicalTrials.gov registry record · Phase 3

Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

A Phase 3 study of Relapsing Remitting Multiple Sclerosis and Relapsing Multiple Sclerosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Recruiting
Registry status
Phase 3
Development phase
156
Enrollment target
20
Study locations

NCT04047628 is a Phase 3 study of Relapsing Remitting Multiple Sclerosis and Relapsing Multiple Sclerosis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 156 participants, below the 196-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04047628, a Phase 3 study of Relapsing Remitting Multiple Sclerosis and Relapsing Multiple Sclerosis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

RECRUITING
Registry status
Phase 3
Development phase
156 participants
Enrollment target
20
Study locations

Study Summary

This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).

Conditions Studied

Relapsing Remitting Multiple Sclerosis Relapsing Multiple Sclerosis Secondary Progressive Multiple Sclerosis

Interventions

  • PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
  • BIOLOGICAL Best Available Therapy (BAT)

Study Locations (20)

Minnesota

  • University of Minnesota Multiple Sclerosis Center - Minneapolis
  • Mayo Clinic - Rochester

New York

  • Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai - New York
  • Rochester Multiple Sclerosis Center, University of Rochester - Rochester

Ohio

  • University of Cincinnati (UC) Waddell Center for Multiple Sclerosis - Cincinnati
  • Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic - Cleveland

Texas

  • University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology - Dallas
  • Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center - Houston

Virginia

  • University of Virginia - Charlottesville
  • Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center - Richmond

Washington

  • Clinical Research Division, Fred Hutchinson Cancer Research Center - Seattle
  • Multiple Sclerosis Center, Swedish Neuroscience Institute - Seattle

California

  • Stanford Multiple Sclerosis Center - Palo Alto

Colorado

  • Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine - Aurora

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2019-12-19
Est. Completion 2029-10
Phase Phase 3

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT04047628

The ClinicalTrials.gov registry entry for NCT04047628 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (20% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Autologous Hematopoietic Stem Cell Transplantation is the first listed.

NCT04047628 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Minnesota, New York, Ohio.

Frequently Asked Questions

What is clinical trial NCT04047628 about?

NCT04047628 is a clinical study titled "Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)". This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multip...

What is the current status of trial NCT04047628?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2019-12-19. Estimated completion is 2029-10.

What conditions does trial NCT04047628 study?

This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis, Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis.

What interventions are being tested in trial NCT04047628?

The interventions under investigation include: Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Best Available Therapy (BAT) (BIOLOGICAL).

Who is sponsoring clinical trial NCT04047628?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04047628 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Massachusetts, Minnesota. 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.