Study Description
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.
Interventions
Disease modifying treatment (DMT)
Ofatumumab
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
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