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NCT05090371 · ClinicalTrials.gov registry record · Phase 4
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
A Phase 4 study of Relapsing Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 4
- Development phase
- 136
- Enrollment target
- 20
- Study locations
NCT05090371: Active Phase 4 study of Relapsing Remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT05090371 is a Phase 4 study of Relapsing Remitting Multiple Sclerosis that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 136 participants, below the 197-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05090371, a Phase 4 study of Relapsing Remitting Multiple Sclerosis, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 136 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Primary Outcome
A participant is considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 3 to 15.
Conditions Studied
Interventions
- DRUG Ofatumumab
- DRUG Disease modifying treatment (DMT)
Study Locations (20)
Florida
- Neurology of Central FL Res Ctr - Altamonte Springs
- S And D Clinical Research - Cape Coral
- Homestead Assoc In Research Inc - Homestead
- Neurology Associates PA - Maitland
- Orlando Health Clinical Trials - Orlando
- Emerald Coast Neurology - Pensacola
- University Of South Florida - Tampa
Alabama
- Alabama Neurology Associates PC - Birmingham
- North Central Neurology Associates PC - Cullman
Arizona
- Radiant Research Chandler - Chandler
- Arizona Neuroscience Research LLC - Phoenix
Michigan
- Henry Ford Hospital - Detroit
- Memorial Healthcare - Owosso
California
- University of California at Los Angeles - Torrance
Idaho
- Kootenai Health - Coeur d'Alene
Louisiana
- Neuro Medial Clinic of Central Louisiana - Alexandria
Maryland
- International Neurorehab Institute - Lutherville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 4 |
What the registry record for NCT05090371 still lists
NCT05090371 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 25 other Relapsing Remitting Multiple Sclerosis trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Relapsing Remitting Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Ofatumumab is the first listed.
NCT05090371 names 20 study sites across 11 states, led by Florida, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05090371 about?
NCT05090371 is a clinical study titled "A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation". This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanc...
What is the current status of trial NCT05090371?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 136 participants. The study started on 2022-03-02. Estimated completion is 2027-03-01.
What conditions does trial NCT05090371 study?
This clinical trial studies the following conditions: Relapsing Remitting Multiple Sclerosis.
What interventions are being tested in trial NCT05090371?
The interventions under investigation include: Ofatumumab (DRUG), Disease modifying treatment (DMT) (DRUG).
Who is sponsoring clinical trial NCT05090371?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05090371 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing Remitting 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 NCT05090371's enrollment target sits among peer trials
136 10th of 25 higher than 16 of 25 other Relapsing Remitting Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Remitting 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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