a multicenter study of continued current therapy vs transition to ofatumumab after neurofilament (nfl) elevation

Conditions: Relapsing-Remitting Multiple Sclerosis

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.

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.

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

Keywords: ofatumumab multiple sclerosis relapsing-remitting multiple sclerosis adult omb157 rrms ms secondary progressive ms relapse