A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
NCT05090371 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2026-03-30
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.
Conditions
- Relapsing-Remitting Multiple Sclerosis
Interventions
- DRUG
-
Ofatumumab
3 loading doses followed by administration every 4 weeks as per label
- DRUG
-
Disease modifying treatment (DMT)
Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-02
- Primary Completion
- 2027-04-13
- Completion
- 2027-04-13
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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