Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis

Prior treatment

• Contraindication to or intolerance of oral or intravenous corticosteroids.
• Treatment with an anti-CD20 or other B-cell-depleting therapy within 6 months before enrollment.

Other illness

• Active hepatitis B.
• Allergy to gadolinium contrast or known allergy to ocrelizumab.
• Another known neurological disorder, including a history of progressive multifocal leukoencephalopathy.
• Active bacterial, viral, fungal, or mycobacterial infection, or a history of recurrent aspiration pneumonia requiring antibiotic treatment.
• A condition that may require chronic systemic corticosteroids or immunosuppressants during the study.
• Active cancer or malignancy.
• Multiple sclerosis, clinically isolated syndrome, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica spectrum disorder (NMOSD), or another neurological disorder that may affect study results.
• An autoimmune, inflammatory, hematologic, or immunodeficiency disorder that may affect B- or T-cell measurements.
• Active bacterial, viral, fungal, or mycobacterial infection at enrollment or blood collection.
• Current use of a disease-modifying therapy, B-cell-depleting therapy, systemic immunosuppressant, immunomodulatory therapy, or chronic systemic corticosteroids.
• Active cancer or malignancy, except adequately treated localized skin cancer if permitted by the investigator.
• A medical condition that, in the investigator's judgment, could increase risk, interfere with participation, or affect interpretation of immune cell or biomarker results.

Other

• Diagnosis of primary progressive multiple sclerosis.
• Current pregnancy.
• Unable to complete an MRI.
• Prisoner status.
• Limited English-speaking capacity.
• Unable to provide informed consent.
  • Healthy Control Participants
• Current pregnancy.
• Unable or unwilling to undergo blood collection.
• Prisoner status.
• Limited English-speaking capacity.
• Unable to provide informed consent.

• Age 18 years or older.
• Diagnosis of relapsing-remitting multiple sclerosis according to the 2017 McDonald criteria.
• At least one gadolinium-enhancing lesion on an MRI of the brain, cervical spine, or thoracic spine within 4 weeks of relapse or hospitalization.
• Age 18 years or older.
• Able and willing to provide written informed consent and undergo study blood draws.
• No diagnosis or history of multiple sclerosis, clinically isolated syndrome, or another inflammatory or demyelinating disorder of the central nervous system.
• In generally good health, as determined by medical history and investigator review.

Criteria the registry did not label

• Participants With Relapsing Multiple Sclerosis (Rapid-Start and Delayed-Start Cohorts)