Study Description
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.
This is a multicenter, prospective study of up to 150 relapsing-remitting MS participants/ The study is looking to see if patients who have not had a relapse in the past year would benefit from switching to ofatumumab.
After giving consent, participants will have a 1 week screening/qualification period. If they qualify to continue, they will start a a six month run-in period during which lab samples will be collected. Patients that are relapse-free during the run-in period will continue into next period of the study in which they will be randomized to either ofatumumab or continued therapy for the next 15 months. Every 3 out of 5 randomized participants will be selected to wear a digital study watch to collect physical activity, sleep, and vitals during this 15 month period. The study watch will be worn 24 hours a day, 7 days a week but can be removed during showers/bathing. At the end of the 15 month period, a study completion visit will be held.
The total study duration is 21 months plus 1 week for screening/qualification.
Interventions
Disease modifying treatment (DMT)
Ofatumumab
Eligibility Criteria
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
Study Location
Novartis Investigative Site
Recruiting
Levis,Quebec,G6W 0M5,Canada
Novartis Investigative Site
Recruiting
Granby,Quebec,J2G 1T7,Canada
Novartis Investigative Site
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Vancouver,British Columbia,V6T 2B5,Canada
Novartis Investigative Site
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Orlando,Florida,32806,United States
Novartis Investigative Site
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Altamonte Springs,Florida,32714,United States
Novartis Investigative Site
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Tampa,Florida,33612,United States
Novartis Investigative Site
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Owosso,Michigan,48867,United States
Novartis Investigative Site
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Birmingham,Alabama,35209,United States
Novartis Investigative Site
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Lubbock,Texas,79410,United States
Novartis Investigative Site
Recruiting
Torrance,California,90509-2004,United States
Novartis Investigative Site
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Green Bay,Wisconsin,54311,United States
Novartis Investigative Site
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Pensacola,Florida,32514,United States
Novartis Investigative Site
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Chapel Hill,North Carolina,27599-9500,United States
Novartis Investigative Site
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Lutherville,Maryland,21093,United States
Novartis Investigative Site
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Houston,Texas,77074,United States
Novartis Investigative Site
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Phoenix,Arizona,85032,United States
Novartis Investigative Site
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Charlotte,North Carolina,28210,United States
Novartis Investigative Site
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Maitland,Florida,32751,United States
Novartis Investigative Site
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Virginia Beach,Virginia,23456,United States
Novartis Investigative Site
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Jackson,Mississippi,39216,United States
Novartis Investigative Site
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Raleigh,North Carolina,27607,United States
Novartis Investigative Site
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Coeur d'Alene,Idaho,83815,United States
Novartis Investigative Site
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Miami,Florida,33032,United States
Novartis Investigative Site
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Webster,Texas,77598,United States
Novartis Investigative Site
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Kirkland,Washington,98034,United States
Novartis Investigative Site
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Seattle,Washington,98122-4379,United States
Novartis Investigative Site
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Cullman,Alabama,35058,United States
Novartis Investigative Site
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Neptune,New Jersey,07753,United States
Novartis Investigative Site
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Worcester,Massachusetts,01608,United States
Novartis Investigative Site
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Alexandria,Louisiana,71301,United States
Novartis Investigative Site
Recruiting
Knoxville,Tennessee,37922,United States
Novartis Investigative Site
Recruiting
Syracuse,New York,13210,United States
Novartis Investigative Site
Recruiting
Detroit,Michigan,48202 2689,United States
Worldwide Contacts
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