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

Running, not enrolling · Phase 4

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT05090371

Run by

Novartis Pharmaceuticals

People needed

136

Starts

2022-03-02

Expected to finish

2027-04-13

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Alabama Neurology Associates PC — Birmingham, Alabama, United States
• North Central Neurology Associates PC — Cullman, Alabama, United States
• Radiant Research Chandler — Chandler, Arizona, United States
• Arizona Neuroscience Research LLC — Phoenix, Arizona, United States
• University of California at Los Angeles — Torrance, California, United States
• Neurology of Central FL Res Ctr — Altamonte Springs, Florida, United States
• S And D Clinical Research — Cape Coral, Florida, United States
• Homestead Assoc In Research Inc — Homestead, Florida, United States
• Neurology Associates PA — Maitland, Florida, United States
• Orlando Health Clinical Trials — Orlando, Florida, United States
• Emerald Coast Neurology — Pensacola, Florida, United States
• University Of South Florida — Tampa, Florida, United States
• Kootenai Health — Coeur d'Alene, Idaho, United States
• Neuro Medial Clinic of Central Louisiana — Alexandria, Louisiana, United States
• International Neurorehab Institute — Lutherville, Maryland, United States
• Reliant Medical Group — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Memorial Healthcare — Owosso, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St Barnabas Medical Center — Livingston, New Jersey, United States
• Jersey Shore University Medical Ctr — Neptune City, New Jersey, United States
• SUNY Upstate Medical Center — Syracuse, New York, United States
• University Of NC At Chapel Hill — Chapel Hill, North Carolina, United States
• Piedmont HealthCare — Charlotte, North Carolina, United States
• Velocity Clinical Research — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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