Multiple Sclerosis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

150

Study ID:

NCT05090371

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 24 Locations for this study

See Locations Near You

Novartis Investigative Site
Birmingham Alabama, 35209, United States
Novartis Investigative Site
Cullman Alabama, 35058, United States
Novartis Investigative Site
Phoenix Arizona, 85032, United States
Novartis Investigative Site
Torrance California, 90509, United States
Novartis Investigative Site
Maitland Florida, 32751, United States
Novartis Investigative Site
Orlando Florida, 32806, United States
Novartis Investigative Site
Coeur d'Alene Idaho, 83815, United States
Novartis Investigative Site
Alexandria Louisiana, 71301, United States
Novartis Investigative Site
Lutherville Maryland, 21093, United States
Novartis Investigative Site
Worcester Massachusetts, 01608, United States
Novartis Investigative Site
Detroit Michigan, 48202, United States
Novartis Investigative Site
Owosso Michigan, 48867, United States
Novartis Investigative Site
Jackson Mississippi, 39216, United States
Novartis Investigative Site
Syracuse New York, 13210, United States
Novartis Investigative Site
Raleigh North Carolina, 27607, United States
Novartis Investigative Site
Knoxville Tennessee, 37922, United States
Novartis Investigative Site
Houston Texas, 77074, United States
Novartis Investigative Site
Lubbock Texas, 79410, United States
Novartis Investigative Site
Webster Texas, 77598, United States
Novartis Investigative Site
Virginia Beach Virginia, 23456, United States
Novartis Investigative Site
Kirkland Washington, 98034, United States
Novartis Investigative Site
Green Bay Wisconsin, 54311, United States
Novartis Investigative Site
Vancouver British Columbia, V6T 2, Canada
Novartis Investigative Site
Levis Quebec, G6W 0, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

150

Study ID:

NCT05090371

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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