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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: Completed Phase 3 study of Relapsing Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient (adjusted for time-in-study by patient). Confirmed relapses are those accompanied by a clinically relevant change in the expanded disability status scale (EDSS). ARR was estimated from fitting a negative binomial regression model with log-link, and adjusted for prior MS therapies as a factor, number of relapses in previous year, baseline EDSS, baseline number of T1 Gd-enhancing lesions
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2025-03-11 |
| Phase | Phase 3 |
What the finished NCT04353492 record still lists
NCT04353492 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, below the 2,145-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (74% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Relapsing Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04353492's enrollment target sits among peer trials
562 11th of 23 higher than 13 of 23 other Relapsing Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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