A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
NCT ID: NCT05090371
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
136 participants
INTERVENTIONAL
2022-03-02
2027-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ofatumumab
20 mg
Ofatumumab
3 loading doses followed by administration every 4 weeks as per label
DMT continued therapy
Participants randomized to the continued therapy arm will continue to take their disease modifying treatment (DMT) as prescribed commercially by their physician.
Disease modifying treatment (DMT)
Other DMT with approved label use for treatment which participants were on at least 6 months prior to Screening
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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COMB157GUS09
Identifier Type: -
Identifier Source: org_study_id