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.

View Full Description

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 33 Locations for this study

See Locations Near You

Alabama Neurology Associates PC CFTY720D2403
Birmingham Alabama, 35209, United States More Info
Emily Sherill Riser
Principal Investigator
North Cntrl Neurology Associates PC
Cullman Alabama, 35058, United States More Info
Contact
256-739-1210
Christopher LaGanke
Principal Investigator
Arizona Neuroscience Research LLC .
Phoenix Arizona, 85032, United States More Info
Contact
480-210-8723
Leslie Zuniga
Principal Investigator
University of California at Los Angeles .
Torrance California, 90509, United States More Info
Contact
949-547-6875
Bijal Mehta
Principal Investigator
Neurology of Central FL Res Ctr
Altamonte Springs Florida, 32714, United States More Info
Contact
407-790-4990
Alicia Cabrera
Principal Investigator
Neurology Associates, PA .
Maitland Florida, 32751, United States More Info
William David Honeycutt
Principal Investigator
Homestead Associates in Research Inc
Miami Florida, 33032, United States More Info
Contact
305-246-0873
Angel Carrasco
Principal Investigator
Orlando Health Clinical Trials .
Orlando Florida, 32806, United States More Info
Tiffany Gilliard
Contact
407-352-5434
[email protected]
Amparo Gutierrez
Principal Investigator
Emerald Coast Neurology
Pensacola Florida, 32514, United States More Info
Contact
850-438-1136
David Bear
Principal Investigator
University Of South Florida
Tampa Florida, 33612, United States More Info
Contact
813-974-6378
John Ciotti
Principal Investigator
Kootenai Health
Coeur d'Alene Idaho, 83815, United States More Info
Contact
208-625-5273
Nina Bozinov
Principal Investigator
Neuro Medial Clinic of Central Louisiana
Alexandria Louisiana, 71301, United States More Info
Contact
318-769-2862
Ariel Antezana-Antezana
Principal Investigator
International Neurorehab Institute
Lutherville Maryland, 21093, United States More Info
Contact
410-828-4629
Daniel Becker
Principal Investigator
Reliant Medical Group
Worcester Massachusetts, 01608, United States More Info
Candace Leblanc
Contact
508-368-3168
[email protected]
Gary Keilson
Principal Investigator
Henry Ford Hospital Main Centre
Detroit Michigan, 48202, United States More Info
Contact
313-556-8186
Mirela Cerghet
Principal Investigator
Memorial Healthcare .
Owosso Michigan, 48867, United States More Info
Jeanie Lynn Cote
Principal Investigator
University of MS Medical Center
Jackson Mississippi, 39216, United States More Info
Contact
888-815-2005
Mary Willis
Principal Investigator
Jersey Shore University Medical Ctr
Neptune New Jersey, 07753, United States More Info
Contact
732-776-4782
David Duncan
Principal Investigator
SUNY Upstate Medical Center .
Syracuse New York, 13210, United States More Info
Corey McGraw
Principal Investigator
University Of NC At Chapel Hill .
Chapel Hill North Carolina, 27599, United States More Info
Contact
919-945-4752
Irena Dujmovic-Basuroski
Principal Investigator
Piedmont HealthCare
Charlotte North Carolina, 28210, United States More Info
Contact
704-664-8060
Matthew Carraro
Principal Investigator
Velocity Clinical Research Drug Shipment
Raleigh North Carolina, 27607, United States More Info
Contact
919-719-8826
Casey Farin
Principal Investigator
Hope Neurology
Knoxville Tennessee, 37922, United States More Info
Contact
865-218-6222
Sibyl Wray
Principal Investigator
Clinical Trial Network FTY720DUS09
Houston Texas, 77074, United States More Info
Santiago Rios
Contact
[email protected]
Djamchid Lotfi
Principal Investigator
Covenant Medical Group
Lubbock Texas, 79410, United States More Info
Contact
806-722-3500
Bhupesh Dihenia
Principal Investigator
Tranquil Clinical Research
Webster Texas, 77598, United States More Info
Amber Christian
Contact
713-906-6316
[email protected]
Razi Rashid
Principal Investigator
Sentara Neuroscience Institute
Virginia Beach Virginia, 23456, United States More Info
Contact
757-507-0642
Michelle Betz-Kuczma
Principal Investigator
Evergreen Health Multiple Sclerosis Center .
Kirkland Washington, 98034, United States More Info
Contact
425-899-5385
Jason Poon
Principal Investigator
Swedish Medical Center .
Seattle Washington, 98122, United States More Info
Contact
206-320-2200
Pavle Repovic
Principal Investigator
Aurora BayCare Medical Center .
Green Bay Wisconsin, 54311, United States More Info
Contact
920-288-8100
James Napier
Principal Investigator
Novartis Investigative Site
Vancouver British Columbia, V6T 2, Canada
Novartis Investigative Site
Granby Quebec, J2G 1, 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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