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

Active Not RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing-Remitting Multiple Sclerosis

Interventions: Ofatumumab, Disease modifying treatment (DMT)

Countries: United States, Canada

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 overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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:

* 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

Locations (43)

Birmingham, Alabama, United States
Cullman, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Torrance, California, United States
Altamonte Springs, Florida, United States
Cape Coral, Florida, United States
Homestead, Florida, United States
Maitland, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Coeur d'Alene, Idaho, United States
Alexandria, Louisiana, United States
Lutherville, Maryland, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Owosso, Michigan, United States
Jackson, Mississippi, United States
Livingston, New Jersey, United States
Neptune City, New Jersey, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Summerville, South Carolina, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Katy, Texas, United States
Lubbock, Texas, United States
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