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
Edmonton,Alberta,T6g 2b7,Canada
Novartis Investigative Site
Recruiting
Levis,Quebec,G6w 0m5,Canada
Novartis Investigative Site
Recruiting
Burnaby,British Columbia,V5g 2x6,Canada
Novartis Investigative Site
Recruiting
Saskatoon,Saskatchewan,S7k 0m7,Canada
Novartis Investigative Site
Recruiting
Vancouver,British Columbia,V6t 2a1,Canada
Orlando Health Clinical Trials
Recruiting
Orlando,Florida,32806,United States
Amparo Gutierrez
Sibyl Wray MD Neurology PC
Recruiting
Knoxville,Tennessee,37922,United States
Sibyl Wray
Medical College of Wisconsin
Recruiting
Milwaukee,Wisconsin,53226,United States
Ahmed Obeidat
Arizona Neuroscience Research LLC
Recruiting
Phoenix,Arizona,85032,United States
Leslie Zuniga
Homestead Assoc In Research Inc
Recruiting
Homestead,Florida,33033,United States
Angel Carrasco
University Of NC At Chapel Hill
Recruiting
Chapel Hill,North Carolina,27599 9500,United States
Irena Dujmovic Basuroski
Reliant Medical Group
Recruiting
Worcester,Massachusetts,01608,United States
Gary Keilson
North Central Neurology Associates PC
Recruiting
Cullman,Alabama,35058,United States
Christopher LaGanke
Evergreen Health Multiple Sclerosis Center
Recruiting
Kirkland,Washington,98034,United States
Jason Poon
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202 2689,United States
Mirela Cerghet
University of California at Los Angeles
Recruiting
Torrance,California,90509-2004,United States
Bijal Mehta
Jersey Shore University Medical Ctr
Recruiting
Neptune,New Jersey,07753,United States
David Duncan
Swedish Medical Center
Recruiting
Seattle,Washington,98122-4379,United States
Pavle Repovic
Neuro Medial Clinic of Central Louisiana
Recruiting
Alexandria,Louisiana,71301,United States
Ariel Antezana-Antezana
Velocity Clinical Research
Recruiting
Raleigh,North Carolina,27607,United States
Casey Farin
Neurology of Central FL Res Ctr
Recruiting
Altamonte Springs,Florida,32714,United States
Alicia Cabrera
Memorial Healthcare
Recruiting
Owosso,Michigan,48867,United States
Jeanie Lynn Cote
Tranquil Clinical Research
Recruiting
Webster,Texas,77598,United States
Razi Rashid
Palmetto Clinical Research
Recruiting
Summerville,South Carolina,29485,United States
Robert Carlile
Neurology Associates PA
Recruiting
Maitland,Florida,32751,United States
William David Honeycutt
Piedmont HealthCare
Recruiting
Charlotte,North Carolina,28210,United States
Matthew Carraro
Aurora BayCare Medical Center
Recruiting
Green Bay,Wisconsin,54311,United States
James Napier
International Neurorehab Institute
Recruiting
Lutherville,Maryland,21093,United States
Daniel Becker
University of Mississippi Medical Center
Recruiting
Jackson,Mississippi,39216-4505,United States
Mary Willis
Clinical Trial Network
Recruiting
Houston,Texas,77074,United States
Djamchid Lotfi
Santiago Rios
Alabama Neurology Associates PC
Recruiting
Birmingham,Alabama,35209,United States
Emily Sherill Riser
Sentara Neuroscience Institute
Recruiting
Virginia Beach,Virginia,23456,United States
Michelle Betz-Kuczma
Neuro Mind Clinical Trials Ltd Co
Recruiting
Katy,Texas,77449,United States
Jontel Pierce
SUNY Upstate Medical Center
Recruiting
Syracuse,New York,13210,United States
Corey McGraw
Worldwide Contacts
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