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NCT04353492 · ClinicalTrials.gov registry record · Phase 3

An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

A Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
562
Enrollment target
20
Study locations

NCT04353492 is a Phase 3 study of Relapsing Multiple Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 562 participants, below the 2,145-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04353492, a Phase 3 study of Relapsing Multiple Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
562 participants
Enrollment target
20
Study locations

Study Summary

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Interventions

  • BIOLOGICAL Ofatumumab

Study Locations (20)

Florida

  • Memorial Healthcare System - Hollywood
  • Homestead Assoc In Research Inc - Homestead
  • Neurology Associates PA - Maitland
  • UM Department Of Neurology - Miami
  • Negroski Neurology - Sarasota
  • Axiom Clinical Research of Florida - Tampa
  • University Of South Florida - Tampa
  • Premiere Research Institute - West Palm Beach

Georgia

  • Atlanta Neuroscience Institute - Atlanta
  • Georgia Neurology and Sleep Medicine Assoc - Suwanee

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • Columbus Neuroscience - Westerville

California

  • Fullerton Neuro and Headache Ctr - Fullerton

Colorado

  • CU Anschutz Med Campus - Aurora

Delaware

  • Christiana Care Health Services - Newark

Maryland

  • Johns Hopkins Hospital - Baltimore

Nevada

  • Cleveland Clinic Foundation - Las Vegas

Trial Details

FieldValue
Enrollment Target 562 participants
Start Date 2020-07-14
Est. Completion 2025-03-11
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT04353492

The ClinicalTrials.gov registry entry for NCT04353492 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 562 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,145-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (74% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ofatumumab is the first listed.

NCT04353492 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Georgia, Ohio.

Frequently Asked Questions

What is clinical trial NCT04353492 about?

NCT04353492 is a clinical study titled "An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab". Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

What is the current status of trial NCT04353492?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 562 participants. The study started on 2020-07-14. Estimated completion is 2025-03-11.

What conditions does trial NCT04353492 study?

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

What interventions are being tested in trial NCT04353492?

The interventions under investigation include: Ofatumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04353492?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04353492 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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