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
Vancouver,British Columbia,V6t 2b5,Canada
Novartis Investigative Site
Recruiting
Granby,Quebec,J2g 1t7,Canada
Novartis Investigative Site
Recruiting
Levis,Quebec,G6w 0m5,Canada
Memorial Healthcare .
Recruiting
Owosso,Michigan,48867,United States
Swedish Medical Center .
Recruiting
Seattle,Washington,98122-4379,United States
Homestead Associates in Research Inc
Recruiting
Miami,Florida,33032,United States
Aurora BayCare Medical Center .
Recruiting
Green Bay,Wisconsin,54311,United States
Neuro Medial Clinic of Central Louisiana
Recruiting
Alexandria,Louisiana,71301,United States
Tranquil Clinical Research
Recruiting
Webster,Texas,77598,United States
Hope Neurology
Recruiting
Knoxville,Tennessee,37922,United States
Orlando Health Clinical Trials .
Recruiting
Orlando,Florida,32806,United States
Clinical Trial Network FTY720DUS09
Recruiting
Houston,Texas,77074,United States
Neurology Associates, PA .
Recruiting
Maitland,Florida,32751,United States
University of California at Los Angeles .
Recruiting
Torrance,California,90509-2004,United States
International Neurorehab Institute
Recruiting
Lutherville,Maryland,21093,United States
Piedmont HealthCare
Recruiting
Charlotte,North Carolina,28210,United States
Covenant Medical Group
Recruiting
Lubbock,Texas,79410,United States
Neurology of Central FL Res Ctr
Recruiting
Altamonte Springs,Florida,32714,United States
University of MS Medical Center
Recruiting
Jackson,Mississippi,39216,United States
Jersey Shore University Medical Ctr
Recruiting
Neptune,New Jersey,07753,United States
Reliant Medical Group
Recruiting
Worcester,Massachusetts,01608,United States
Emerald Coast Neurology
Recruiting
Pensacola,Florida,32514,United States
North Cntrl Neurology Associates PC
Recruiting
Cullman,Alabama,35058,United States
University Of NC At Chapel Hill .
Recruiting
Chapel Hill,North Carolina,27599-9500,United States
Kootenai Health
Recruiting
Coeur d'Alene,Idaho,83815,United States
Sentara Neuroscience Institute
Recruiting
Virginia Beach,Virginia,23456,United States
Evergreen Health Multiple Sclerosis Center .
Recruiting
Kirkland,Washington,98034,United States
University Of South Florida
Recruiting
Tampa,Florida,33612,United States
Alabama Neurology Associates PC CFTY720D2403
Recruiting
Birmingham,Alabama,35209,United States
Medical College of Wisconsin .
Recruiting
Milwaukee,Wisconsin,53226,United States
SUNY Upstate Medical Center .
Recruiting
Syracuse,New York,13210,United States
Henry Ford Hospital Main Centre
Recruiting
Detroit,Michigan,48202 2689,United States
Arizona Neuroscience Research LLC .
Recruiting
Phoenix,Arizona,85032,United States
Velocity Clinical Research Drug Shipment
Recruiting
Raleigh,North Carolina,27607,United States
Worldwide Contacts
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