💬In plain words
What the trial is, and whether it could suit you
This study will compare starting Ocrevus Zunovo soon after an active episode of relapsing multiple sclerosis (MS) with starting it later. Researchers want to learn whether starting treatment sooner reduces the number of MS relapses over 18 months. They will also study changes in immune cells, blood markers, disability, and MRI scans.
About 35 adults with relapsing MS will take part at Oklahoma Medical Research Foundation or Corewell Health West. One group will start Ocrevus Zunovo before leaving the clinic or hospital. The other group will start treatment later. Ocrevus Zunovo is given as an injection under the skin. Participants will have blood draws and follow-up visits for up to 18 months. Researchers will also review their medical records for relapses, steroid treatments, emergency department visits, and hospital stays.
About 10 adults without MS will provide blood samples to help
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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