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Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis

Starting Treatment at Time Zero With Ocrevus Zunovo (STAT Ocrevus Zunovo)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 18 months
  • Procedures mentioned: MRI scans, Injections, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Ocrevus Zunovo is given as an injection under the skin."
  • "Participants will have blood draws and follow-up visits for up to 18 months."
  • "The primary objective is to compare annualized relapse rates over 18 months."
  • "Secondary assessments include changes in B- and T-cell populations and other blood biomarkers, disability scores, MRI findings, and health care use."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether starting Ocrevus Zunovo soon after an MS flare-up leads to fewer flare-ups over 18 months than starting it later. It is for adults with relapsing MS, which causes repeated flare-ups. Adults without MS will also give blood samples for comparison.

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 researchers compare immune cell measurements.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: You must be at least 18 years old.
  • MS group: You must have relapsing-remitting MS diagnosed using the study’s medical guidelines.
  • MS group: An MRI scan of your brain or spine must show at least one active spot using contrast dye within 4 weeks of a flare-up or hospital stay.
  • Comparison group: You must be in generally good health, based on your health history and the study doctor’s review.
  • Comparison group: You must have no history of MS, a first episode of MS-like symptoms, or a disease that causes swelling or damages nerve coverings in the brain or spinal cord.
  • Comparison group: You must agree in writing to join and be able and willing to have blood drawn.

Who can't join

  • Both groups: You cannot join if you are pregnant, have an active infection, are a prisoner, have limited ability to speak English, or cannot give informed consent.
  • Both groups: Active cancer rules you out. The comparison group may allow treated skin cancer that has not spread, if the study doctor approves.
  • MS group: You cannot have primary progressive MS, which steadily worsens, or another known nerve or brain disorder, including a past serious brain infection called PML.
  • MS group: You cannot have an allergy to MRI contrast dye or ocrelizumab, be unable to complete an MRI, or be unable to safely take steroid pills or steroid treatment through a vein.
  • MS group: You cannot have repeated pneumonia from food or liquid entering the lungs that needed antibiotics, need long-term whole-body steroids or immune-suppressing drugs during the study, or have received treatment that removes B cells in the past 6 months. B cells are immune cells.
  • Comparison group: You cannot have MS, a first episode of MS-like symptoms, MOGAD, NMOSD, or another nerve or brain disorder that could affect results. MOGAD and NMOSD can damage nerve coverings.
  • Comparison group: You cannot have an immune, blood, or inflammation-related disorder that could affect immune cell tests, or currently use disease-modifying drugs, drugs that remove B cells, drugs that change or suppress the immune system, or long-term whole-body steroids.
  • Comparison group: You cannot join if you cannot or will not have blood drawn, or if the study doctor finds a condition that could make joining unsafe, limit participation, or affect blood test results.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

OK