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
Novartis Investigative Site
Recruiting
Granby,Quebec,J2g 1t7,Canada
Novartis Investigative Site
Recruiting
Vancouver,British Columbia,V6t 2a1,Canada
Novartis Investigative Site
Recruiting
Levis,Quebec,G6w 0m5,Canada
Novartis Investigative Site
Recruiting
Saskatoon,Saskatchewan,S7k 0m7,Canada
Homestead Assoc In Research Inc
Recruiting
Homestead,Florida,33033,United States
Angel Carrasco
International Neurorehab Institute
Recruiting
Lutherville,Maryland,21093,United States
Daniel Becker
University of California at Los Angeles .
Recruiting
Torrance,California,90509-2004,United States
Bijal Mehta
Velocity Clinical Research Drug Shipment
Recruiting
Raleigh,North Carolina,27607,United States
Casey Farin
Evergreen Health Multiple Sclerosis Center .
Recruiting
Kirkland,Washington,98034,United States
Jason Poon
University of Mississippi Medical Center U of Mississippi
Recruiting
Jackson,Mississippi,39216-4505,United States
Mary Willis
Alabama Neurology Associates PC CFTY720D2403
Recruiting
Birmingham,Alabama,35209,United States
Emily Sherill Riser
Jersey Shore University Medical Ctr
Recruiting
Neptune,New Jersey,07753,United States
David Duncan
Neurology Associates PA .
Recruiting
Maitland,Florida,32751,United States
William David Honeycutt
Medical College of Wisconsin .
Recruiting
Milwaukee,Wisconsin,53226,United States
Ahmed Obeidat
Neurology of Central FL Res Ctr
Recruiting
Altamonte Springs,Florida,32714,United States
Alicia Cabrera
University Of NC At Chapel Hill .
Recruiting
Chapel Hill,North Carolina,27599 9500,United States
Irena Dujmovic Basuroski
North Central Neurology Associates PC
Recruiting
Cullman,Alabama,35058,United States
Christopher LaGanke
Reliant Medical Group
Recruiting
Worcester,Massachusetts,01608,United States
Gary Keilson
Swedish Medical Center .
Recruiting
Seattle,Washington,98122-4379,United States
Pavle Repovic
SUNY Upstate Medical Center .
Recruiting
Syracuse,New York,13210,United States
Corey McGraw
Orlando Health Clinical Trials .
Recruiting
Orlando,Florida,32806,United States
Amparo Gutierrez
Tranquil Clinical Research
Recruiting
Webster,Texas,77598,United States
Razi Rashid
Clinical Trial Network FTY720DUS09
Recruiting
Houston,Texas,77074,United States
Djamchid Lotfi
Santiago Rios
Piedmont HealthCare
Recruiting
Charlotte,North Carolina,28210,United States
Matthew Carraro
Arizona Neuroscience Research LLC .
Recruiting
Phoenix,Arizona,85032,United States
Leslie Zuniga
Henry Ford Hospital Main Centre
Recruiting
Detroit,Michigan,48202 2689,United States
Mirela Cerghet
Neuro Medial Clinic of Central Louisiana
Recruiting
Alexandria,Louisiana,71301,United States
Ariel Antezana-Antezana
Aurora BayCare Medical Center .
Recruiting
Green Bay,Wisconsin,54311,United States
James Napier
Sentara Neuroscience Institute
Recruiting
Virginia Beach,Virginia,23456,United States
Michelle Betz-Kuczma
Memorial Healthcare .
Recruiting
Owosso,Michigan,48867,United States
Jeanie Lynn Cote
Worldwide Contacts
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