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A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
Sponsor: Novartis Pharmaceuticals
Summary
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.
Official title: A Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2022-03-02
Completion Date
2027-04-13
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Ofatumumab
3 loading doses followed by administration every 4 weeks as per label
Disease modifying treatment (DMT)
Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening
Locations (43)
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
Palmetto Clinical Research
Summerville, South Carolina, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Clinical Trial Network
Houston, Texas, United States
Neuro Mind Clinical Trials Ltd Co
Katy, Texas, United States
Covenant Medical Group
Lubbock, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, United States
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Burnaby, British Columbia, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Granby, Quebec, Canada
Novartis Investigative Site
Lévis, Quebec, Canada
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada