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

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Relapsing-Remitting Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Alabama Neurology Associates PC CFTY720D2403, Birmingham, Alabama, United States, 35209

Cullman

North Central Neurology Associates PC, Cullman, Alabama, United States, 35058

Phoenix

Arizona Neuroscience Research LLC ., Phoenix, Arizona, United States, 85032

Torrance

University of California at Los Angeles ., Torrance, California, United States, 90509-2004

Altamonte Springs

Neurology of Central FL Res Ctr, Altamonte Springs, Florida, United States, 32714

Cape Coral

S And D Clinical Research, Cape Coral, Florida, United States, 33904

Homestead

Homestead Assoc In Research Inc, Homestead, Florida, United States, 33033

Maitland

Neurology Associates PA ., Maitland, Florida, United States, 32751

Orlando

Orlando Health Clinical Trials ., Orlando, Florida, United States, 32806

Pensacola

Emerald Coast Neurology, Pensacola, Florida, United States, 32514

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2026-12-31