Early start of Ocrevus Zunovo for relapsing MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this open-label study, about 35 adults with relapsing MS are assigned to rapid-start or delayed-start groups to compare relapse rates over 18 months after beginning Ocrevus Zunovo, an subcutaneous B-cell–depleting therapy. Researchers will measure relapses, disability, MRI changes, and immune biomarkers, including B- and T-cell populations and neurofilament light chain. Blood samples are taken around the first injection and during follow-up to track biomarkers, while standard clinical assessments and medical record reviews capture health care utilization and outcomes. The study aims to see if quicker initiation after a relapse reduces relapses and disease activity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Oklahoma Medical Research Foundation
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Yang Mao-Draayer, MD, PhD — Oklahoma Medical Research Foundation
• Study coordinator: Meerah Khan, MPH
• Email: khanm@omrf.org
• Phone: 6312205983

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.