Ireland
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Active, not recruiting Phase 4

A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

NCT05090371 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2022-03-02
Last updated
2026-05-29

Condition(s) studied

Relapsing-Remitting Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ofatumumab →Disease modifying treatment (DMT)

Ofatumumab: 3 loading doses followed by administration every 4 weeks as per label

Disease modifying treatment (DMT): Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Age 18-45 years * Diagnosis of RRMS per McDonald Criteria (2017) * EDSS 0-5.5 (Inclusive) * Able to obtain MRI and attend study visits at sites * Willing to use wearable device as specified in the protocol * Able to provide blood sample * On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening * No relapse reported within 6 months prior to Screening * Patients may enroll in the trial if they have subclinical disease activity as measured by MRI prior to enrollment. An absence of MRI activity is not exclusionary. Exclusion Criteria: * Primary progressive or secondary progressive phenotype * Diseases other than multiple sclerosis responsible for the clinical or MRI presentation * Use of experimental or investigational drugs for MS within 2 years from Screening * Known sensitivity to gadolinium * Central Nervous System (CNS) anomalies that are better accounted for by another disease process * Known active malignancies * Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS * Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML * IgG or IgM levels below lower limit of normal (LLN) at Screening

Primary outcome measure(s)

  • Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3) — Months 3 to 15
    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.

Trial sites (43)

FacilityCityRegionStatus
Alabama Neurology Associates PC Birmingham Alabama
North Central Neurology Associates PC Cullman Alabama
Radiant Research Chandler Chandler Arizona
Arizona Neuroscience Research LLC Phoenix Arizona
University of California at Los Angeles Torrance California
Neurology of Central FL Res Ctr Altamonte Springs Florida
S And D Clinical Research Cape Coral Florida
Homestead Assoc In Research Inc Homestead Florida
Neurology Associates PA Maitland Florida
Orlando Health Clinical Trials Orlando Florida
Emerald Coast Neurology Pensacola Florida
University Of South Florida Tampa Florida
Kootenai Health Coeur d'Alene Idaho
Neuro Medial Clinic of Central Louisiana Alexandria Louisiana
International Neurorehab Institute Lutherville Maryland
Reliant Medical Group Worcester Massachusetts
Henry Ford Hospital Detroit Michigan
Memorial Healthcare Owosso Michigan
University of Mississippi Medical Center Jackson Mississippi
St Barnabas Medical Center Livingston New Jersey
Jersey Shore University Medical Ctr Neptune City New Jersey
SUNY Upstate Medical Center Syracuse New York
University Of NC At Chapel Hill Chapel Hill North Carolina
Piedmont HealthCare Charlotte North Carolina
Velocity Clinical Research Raleigh North Carolina
Palmetto Clinical Research Summerville South Carolina
Sibyl Wray MD Neurology PC Knoxville Tennessee
Clinical Trial Network Houston Texas
Neuro Mind Clinical Trials Ltd Co Katy Texas
Covenant Medical Group Lubbock Texas
West Texas Cancer Center Odessa Texas
Tranquil Clinical Research Webster Texas
Sentara Neuroscience Institute Virginia Beach Virginia
Evergreen Health Multiple Sclerosis Center Kirkland Washington
Swedish Medical Center Seattle Washington
Aurora BayCare Medical Center Green Bay Wisconsin
Medical College of Wisconsin Milwaukee Wisconsin
Novartis Investigative Site Edmonton Alberta
Novartis Investigative Site Burnaby British Columbia
Novartis Investigative Site Vancouver British Columbia

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05090371 on ClinicalTrials.gov ↗ ← All trials in the USA