Study Details

Open

A randomized open label trial examining the effectiveness of Ofatumumab versus current therapy on relapsing multiple sclerosis.

This study aims to investigate whether multiple sclerosis patients who haven't had a relapse within the past year would benefit from switching to ofatumumab VS. continuing their current therapy, based on measures of disease activity, and a baseline neurofilament light level. Neurofilament is a marker of nerve cell loss in the brain and spinal cord and even people with no MS relapses who may have a stable lesions on the MRI will have a continued slow nerve cell loss which is different in each person. Neurofilament levels in blood help us get an impression on the degree of that nerve cell loss.

Age & Gender

18 years ~ 45 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
In-home visits available

Location

North Carolina (Statewide), South Carolina, Virginia, West Virginia

What will be asked of you

During this study you will be asked to complete a total of 13 study visits, and will be asked to undergo different procedures at different visits. You will be asked to provide information about your personal health information, demographics, or other information relevant to the study. You will be asked to undergo physical examinations to determine the status of your MS, and whether or not you have had a relapse. You will be asked to provide a small blood sample, which will be sent to a central lab and evaluated. You will be asked to undergo an MRI at some visits. You might be assigned to wear a smartwatch device to monitor vitals and activities. If you are assigned to the new medication, you will be asked to take it, and follow instructions concerning dosing, maintenance, and return, of the drug.

Incentives

$75 dollar compensation for each study visit you complete, as well as $75 dollars to compensate for travel and lodging.

In-person visits:
9-13

Phone or online visits:
0-4

Total length of participation:
22 Months

Looking for Specific Volunteers

Able to participate:

You have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) per McDonald Criteria
You are not severely disabled ( your disability is measured by an EDSS score within the range of 0-5.5)
On a current DMT ,that is approved for use with RRMS, for at least 6 months prior to screening
No relapse of RRMS within 6 months prior to screening
Able to undergo MRI and provide blood samples.

Not eligible if:

Classification is having primary progressive or secondary progressive multiple sclerosis.
Use of experimental or investigational drugs for multiple sclerosis within 2 years of screening.
Diagnosis of other active chronic diseases affecting the immune system, or immunodeficiency syndrome.
Currently treated with off label drugs for RRMS.
Womenof child bearing potential, defined as any individually physiologically capable of becoming pregnant, who are not willing to use effective contraceptive methods.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Adult Neurology Outpatient Clinic
UNC Meadowmont
300 Meadowmont Village Cir, Chapel Hill, NC 27517, USA

Additional Study Information

Principal Investigator

Irena Dujmovic Basuroski
Neurology

Study Type

Clinical or Medical
Interventional

Study Topics

Chronic Conditions
Immune System/Infections

IRB Number

22-0704

ClinicalTrials.gov

NCT05090371