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NCT05084638 · ClinicalTrials.gov registry record · Phase 4
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
A Phase 4 study of Relapse Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT05084638: Completed Phase 4 study of Relapse Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT05084638 is a Phase 4 study of Relapse Remitting Multiple Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 180 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05084638, a Phase 4 study of Relapse Remitting Multiple Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
Primary Outcome
A participant is considered as achieved NEDA-3 if they were: * relapse-free, defined as no confirmed relapses in month 6 to 18. * 3-month clinical disability progression-free, defined as no clinical disability progression as measured by EDSS in month 6 to 18. * MRI activity-free, defined as no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indi
Conditions Studied
Interventions
- DRUG Ofatumumab
Study Locations (20)
Florida
- Neurology of Central FL Res Ctr - Altamonte Springs
- First Choice Neurology - Boca Raton
- University of Florida - Gainesville
- Neurology Associates PA - Maitland
- Orlando Health Clinical Trials - Orlando
- Emerald Coast Neurology - Pensacola
- Tallahassee Neurological Clinic - Tallahassee
- University Of South Florida - Tampa
Arizona
- MD First Research - Chandler
- Barrow Neurological Clinics at St Josephs Hospital and MC - Phoenix
- Arizona Neuroscience Research LLC - Phoenix
California
- Keck School of Medicine - Los Angeles
- Lundquist Inst BioMed at Harbor - Torrance
- Regina Berkovich MD PhD Inc - West Hollywood
Colorado
- UC Health Neuroscience Ctr - Aurora
District of Columbia
- MedStar Health - Washington D.C.
Georgia
- Shepherd Center - Atlanta
Louisiana
- Ochsner Cancer Institute - New Orleans
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2026-02-11 |
| Phase | Phase 4 |
What the finished NCT05084638 record still lists
NCT05084638 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Relapse Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ofatumumab is the first listed.
NCT05084638 names 20 study sites across 9 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05084638 about?
NCT05084638 is a clinical study titled "Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.". This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques includin...
What is the current status of trial NCT05084638?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2022-01-25. Estimated completion is 2026-02-11.
What conditions does trial NCT05084638 study?
This clinical trial studies the following conditions: Relapse Remitting Multiple Sclerosis.
What interventions are being tested in trial NCT05084638?
The interventions under investigation include: Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT05084638?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05084638 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05084638's enrollment target sits among peer trials
180 466th of 2000 higher than 1,526 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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