ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2022-03-02
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05090371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent must be obtained prior to participation in the study.
  2. * Age 18-45 years
  3. * Diagnosis of RRMS per McDonald Criteria (2017)
  4. * EDSS 0-5.5 (Inclusive)
  5. * Able to obtain MRI and attend study visits at sites
  6. * Willing to use wearable device as specified in the protocol
  7. * Able to provide blood sample
  8. * On a current DMT with approved label use for treatment of RRMS at least 6 months prior to Screening
  9. * No relapse reported within 6 months prior to Screening
  10. * 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.
  1. * Primary progressive or secondary progressive phenotype
  2. * Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
  3. * Use of experimental or investigational drugs for MS within 2 years from Screening
  4. * Known sensitivity to gadolinium
  5. * Central Nervous System (CNS) anomalies that are better accounted for by another disease process
  6. * Known active malignancies
  7. * Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
  8. * Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies
  9. * Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
  10. * IgG or IgM levels below lower limit of normal (LLN) at Screening

Contacts and Locations

Study Locations (Sites)

Alabama Neurology Associates PC
Birmingham, Alabama, 35209
United States
North Central Neurology Associates PC
Cullman, Alabama, 35058
United States
Radiant Research Chandler
Chandler, Arizona, 85224
United States
Arizona Neuroscience Research LLC
Phoenix, Arizona, 85032
United States
University of California at Los Angeles
Torrance, California, 90509-2004
United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714
United States
S And D Clinical Research
Cape Coral, Florida, 33904
United States
Homestead Assoc In Research Inc
Homestead, Florida, 33033
United States
Neurology Associates PA
Maitland, Florida, 32751
United States
Orlando Health Clinical Trials
Orlando, Florida, 32806
United States
Emerald Coast Neurology
Pensacola, Florida, 32514
United States
University Of South Florida
Tampa, Florida, 33612
United States
Kootenai Health
Coeur d'Alene, Idaho, 83815
United States
Neuro Medial Clinic of Central Louisiana
Alexandria, Louisiana, 71301
United States
International Neurorehab Institute
Lutherville, Maryland, 21093
United States
Reliant Medical Group
Worcester, Massachusetts, 01608
United States
Henry Ford Hospital
Detroit, Michigan, 48202 2689
United States
Memorial Healthcare
Owosso, Michigan, 48867
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
St Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Jersey Shore University Medical Ctr
Neptune City, New Jersey, 07753
United States
SUNY Upstate Medical Center
Syracuse, New York, 13210
United States
University Of NC At Chapel Hill
Chapel Hill, North Carolina, 27599 9500
United States
Piedmont HealthCare
Charlotte, North Carolina, 28210
United States
Velocity Clinical Research
Raleigh, North Carolina, 27607
United States
Palmetto Clinical Research
Summerville, South Carolina, 29485
United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922
United States
Clinical Trial Network
Houston, Texas, 77074
United States
Neuro Mind Clinical Trials Ltd Co
Katy, Texas, 77449
United States
Covenant Medical Group
Lubbock, Texas, 79410
United States
West Texas Cancer Center
Odessa, Texas, 79761
United States
Tranquil Clinical Research
Webster, Texas, 77598
United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, 23456
United States
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, 98034
United States
Swedish Medical Center
Seattle, Washington, 98122-4379
United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2022-03-02
Study Completion Date2027-03-01

Terms related to this study

Keywords Provided by Researchers

  • Ofatumumab
  • Multiple Sclerosis
  • Relapsing-Remitting Multiple Sclerosis
  • adult
  • OMB157
  • RRMS
  • MS
  • secondary progressive MS
  • relapse

Additional Relevant MeSH Terms

  • Relapsing-Remitting Multiple Sclerosis