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

Korábbi kezelés

• Use of experimental or investigational drugs for MS within 2 years from Screening
• Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS

Más betegség

• Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
• Central Nervous System (CNS) anomalies that are better accounted for by another disease process
• Known active malignancies
• Active infections including systemic bacterial, viral (including COVID-19) or fungal infections, known to have AIDS or tested positive for HIV antibodies

Egyéb

• Primary progressive or secondary progressive phenotype
• Known sensitivity to gadolinium
• Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
• IgG or IgM levels below lower limit of normal (LLN) at Screening

• 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.