Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
Relapse Remitting Multiple Sclerosis
What This Study Is About
Who Can Participate
- 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.
- +2 more...
- Diagnosis of primary progressive multiple sclerosis.
- Current pregnancy.
- Allergy to gadolinium contrast or known allergy to ocrelizumab.
- Unable to complete an MRI.
- Contraindication to or intolerance of oral or intravenous corticosteroids.
- +15 more...
- Active hepatitis B.
- A condition that may require chronic systemic corticosteroids or immunosuppressants during the study.
- Active cancer or malignancy.
- An autoimmune, inflammatory, hematologic, or immunodeficiency disorder that may affect B- or T-cell measurements.
- Current use of a disease-modifying therapy, B-cell-depleting therapy, systemic immunosuppressant, immunomodulatory therapy, or chronic systemic corticosteroids.
- +1 more items to discuss...
- Age 18+ years
- Able to provide informed consent
View Full Eligibility Criteria
Participants With Relapsing Multiple Sclerosis (Rapid-Start and Delayed-Start Cohorts) Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of primary progressive multiple sclerosis. * Active hepatitis B. * Current pregnancy. * Allergy to gadolinium contrast or known allergy to ocrelizumab. * Unable to complete an MRI. * Contraindication to or intolerance of oral or intravenous corticosteroids. * 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. * Treatment with an anti-CD20 or other B-cell-depleting therapy within 6 months before enrollment. * Active cancer or malignancy. * Prisoner status. * Limited English-speaking capacity. * Unable to provide informed consent. Healthy Control Participants Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Current pregnancy. * A medical condition that, in the investigator's judgment, could increase risk, interfere with participation, or affect interpretation of immune cell or biomarker results. * Unable or unwilling to undergo blood collection. * Prisoner status. * Limited English-speaking capacity. * Unable to provide informed consent.
Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.
Study Locations
Contact
Experimental Treatment
This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.
Your information will be sent to the study coordinator for review.