A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

Last updated: January 21, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Neurologic Disorders

Multiple Sclerosis

Scar Tissue

Treatment

Disease modifying treatment (DMT)

Ofatumumab

Clinical Study ID

NCT05090371
COMB157GUS09
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 monthsprior to Screening

  • No relapse reported within 6 months prior to Screening

  • Patients may enroll in the trial if they have subclinical disease activity asmeasured by MRI prior to enrollment. An absence of MRI activity is not exclusionary.

Exclusion

Exclusion Criteria:

  • Primary progressive or secondary progressive phenotype

  • Diseases other than multiple sclerosis responsible for the clinical or MRIpresentation

  • 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 anotherdisease process

  • Known active malignancies

  • Active chronic disease (or stable but treated with immune therapy) of the immunesystem other than MS

  • Active infections including systemic bacterial, viral (including COVID-19) or fungalinfections, 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 Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Disease modifying treatment (DMT)
Phase: 4
Study Start date:
March 02, 2022
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Burnaby, British Columbia V5G 2X6
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Vancouver, British Columbia V6T 2A1
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Granby, Quebec J2G 1T7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Levis, Quebec G6W 0M5
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Saskatoon, Saskatchewan S7K 0M7
    Canada

    Active - Recruiting

  • Alabama Neurology Associates PC

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Alabama Neurology Associates PC CFTY720D2403

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • North Central Neurology Associates PC

    Cullman, Alabama 35058
    United States

    Active - Recruiting

  • North Cntrl Neurology Associates PC

    Cullman, Alabama 35058
    United States

    Site Not Available

  • Novartis Investigative Site

    Cullman, Alabama 35058
    United States

    Active - Recruiting

  • Arizona Neuroscience Research LLC

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Arizona Neuroscience Research LLC .

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Torrance, California 90509-2004
    United States

    Active - Recruiting

  • University of California at Los Angeles

    Torrance, California 90509-2004
    United States

    Active - Recruiting

  • University of California at Los Angeles .

    Torrance, California 90509-2004
    United States

    Active - Recruiting

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida 32714
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Altamonte Springs, Florida 32714
    United States

    Active - Recruiting

  • S And D Clinical Research

    Cape Coral, Florida 33904
    United States

    Active - Recruiting

  • Homestead Assoc In Research Inc

    Homestead, Florida 33033
    United States

    Active - Recruiting

  • Neurology Associates PA

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Neurology Associates PA .

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Neurology Associates, PA .

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Homestead Associates in Research Inc

    Miami, Florida 33032
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami, Florida 33032
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Orlando Health Clinical Trials

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Orlando Health Clinical Trials .

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Emerald Coast Neurology

    Pensacola, Florida 32514
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Pensacola, Florida 32514
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • University Of South Florida

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Kootenai Health

    Coeur d'Alene, Idaho 83815
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Coeur d'Alene, Idaho 83815
    United States

    Active - Recruiting

  • Neuro Medial Clinic of Central Louisiana

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Alexandria, Louisiana 71301
    United States

    Active - Recruiting

  • International Neurorehab Institute

    Lutherville, Maryland 21093
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Lutherville, Maryland 21093
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Worcester, Massachusetts 01608
    United States

    Active - Recruiting

  • Reliant Medical Group

    Worcester, Massachusetts 01608
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202 2689
    United States

    Active - Recruiting

  • Henry Ford Hospital Main Centre

    Detroit, Michigan 48202 2689
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Detroit, Michigan 48202 2689
    United States

    Active - Recruiting

  • Memorial Healthcare

    Owosso, Michigan 48867
    United States

    Active - Recruiting

  • Memorial Healthcare .

    Owosso, Michigan 48867
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Owosso, Michigan 48867
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • University of MS Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Active - Recruiting

  • University of Mississippi Medical Center U of Mississippi

    Jackson, Mississippi 39216-4505
    United States

    Active - Recruiting

  • Jersey Shore University Medical Ctr

    Neptune, New Jersey 07753
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Neptune, New Jersey 07753
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • SUNY Upstate Medical Center

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • SUNY Upstate Medical Center .

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Chapel Hill, North Carolina 27599-9500
    United States

    Active - Recruiting

  • University Of NC At Chapel Hill

    Chapel Hill, North Carolina 27599 9500
    United States

    Active - Recruiting

  • University Of NC At Chapel Hill .

    Chapel Hill, North Carolina 27599 9500
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Charlotte, North Carolina 28210
    United States

    Active - Recruiting

  • Piedmont HealthCare

    Charlotte, North Carolina 28210
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Velocity Clinical Research Drug Shipment

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Palmetto Clinical Research

    Summerville, South Carolina 29485
    United States

    Active - Recruiting

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Clinical Trial Network FTY720DUS09

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Neuro Mind Clinical Trials Ltd Co

    Katy, Texas 77449
    United States

    Active - Recruiting

  • Covenant Medical Group

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • West Texas Cancer Center

    Odessa, Texas 79761
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Tranquil Clinical Research

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

  • Evergreen Health Multiple Sclerosis Center

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • Evergreen Health Multiple Sclerosis Center .

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Seattle, Washington 98122-4379
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98122-4379
    United States

    Active - Recruiting

  • Swedish Medical Center .

    Seattle, Washington 98122-4379
    United States

    Active - Recruiting

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin 54311
    United States

    Active - Recruiting

  • Aurora BayCare Medical Center .

    Green Bay, Wisconsin 54311
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Green Bay, Wisconsin 54311
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Medical College of Wisconsin .

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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