Relapse Remitting Multiple SclerosisSTATNCT07878923
Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
An observational study of Relapse Remitting Multiple Sclerosis, run by Oklahoma Medical Research Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relapse Remitting Multiple Sclerosis
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 31 Dec 2029
- How long will I take part?
- 18 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with relapsing-remitting multiple sclerosis who are seen during an inpatient or emergency department stay at Corewell Health West or in the outpatient clinic at Oklahoma Medical Research Foundation (OMRF) will be screened for the two MS cohorts. Adults without multiple sclerosis will be recruited at OMRF as healthy controls for blood-based immune cell comparisons. Approximately 35 participants with MS and 10 healthy controls will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73142
Meerah Khan, MPH, 6312205983, khanm@omrf.org
Yang Mao-Draayer, MD, PhD, Yang-Mao-Draayer@omrf.org
About this study
Official title: Starting Treatment at Time Zero With Ocrevus Zunovo (STAT Ocrevus Zunovo)
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.
Read the detailed description
This prospective, open-label, controlled study will compare rapid initiation of Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) with delayed initiation in adults with relapsing multiple sclerosis (MS). 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.
Approximately 35 adults with relapsing MS will be enrolled at two sites. The rapid-initiation group will include approximately 18 participants recruited at Corewell Health West who begin treatment before leaving the clinic or at emergency department or hospital discharge. The delayed-initiation group will include approximately 17 participants recruited at Oklahoma Medical Research Foundation (OMRF). Both groups will receive Ocrevus Zunovo as a subcutaneous injection and be followed for 18 months. This is an open-label study; participants and investigators will know which group each participant is in.
Blood samples will be collected before treatment and approximately 1 to 2 hours after the first injection, with additional samples planned after treatment and during follow-up. Researchers will examine immune cell populations, neurofilament light chain, and other biomarkers. Clinical assessments will include MS relapses, Expanded Disability Status Scale (EDSS) scores, patient questionnaires, and review of standard-of-care MRI scans. Medical records will also be reviewed for high-dose steroid treatment, emergency department visits, and hospital admissions.
Approximately 10 healthy adults will be enrolled at OMRF to provide comparison blood samples for immune cell measurements. Healthy control participants will not receive Ocrevus Zunovo.
- Conditions
- Relapse Remitting Multiple Sclerosis
- Keywords
- Ocrevus Zunovo, Ocrelizumab, Relapsing Multiple Sclerosis, Early Treatment Initiation, B-Cell Depletion, Neurofilament Light Chain
- Medical subject headings
- Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rapid-Start MS Cohort | Approximately 18 adults with relapsing multiple sclerosis who begin Ocrevus Zunovo before leaving the clinic or at emergency department or hospital discharge. Participants are followed for 18 months to assess relapses, clinical outcomes, MRI findings, and blood biomarkers. | |
| Delayed-Start MS Cohort | Approximately 17 adults with relapsing multiple sclerosis who begin Ocrevus Zunovo later in outpatient care. Participants are followed for 18 months using the same clinical and biomarker assessments as the rapid-start cohort. | |
| Healthy Control Cohort | Approximately 10 adults without multiple sclerosis or another inflammatory or demyelinating disorder of the central nervous system. Blood samples are collected to provide comparison measurements for immune cell and biomarker analyses. These participants do not receive Ocrevus Zunovo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate Over 18 Months.
Annualized relapse rate is the number of confirmed multiple sclerosis relapses per participant, adjusted to a one-year period. Relapses occurring during the 18-month follow-up will be identified through clinical assessments and medical record review. The rate will be compared between the rapid-start and delayed-start MS cohorts.
Measured: From baseline through 18 months of follow-up.
Secondary outcomes (8)
Change in Expanded Disability Status Scale (EDSS) Score From Baseline to 18 Months.
Change in Expanded Disability Status Scale (EDSS) score from baseline to 18 months in participants with multiple sclerosis. EDSS is a clinician-rated measure of neurological disability scored from 0 (normal neurological examination) to 10 (death due to multiple sclerosis). Higher scores indicate greater disability.
Measured: Baseline and 18 months.
Change in B- and T-Cell Populations
Changes in the proportions or counts of B- and T-cell subsets measured in blood samples, including CD20-positive T cells and regulatory, memory, and other immune cell subsets.
Measured: Baseline through 18 months
Time Course of B- and T-Cell Depletion and Repletion
Changes in B- and T-cell populations after Ocrevus Zunovo initiation, including how quickly measured cell populations decrease and recover.
Measured: Before treatment through 18 months
Change in Immunophenotyping and Multi-Omics Profiles
Changes in blood-based immune profiles and other molecular measurements over follow-up.
Measured: Baseline through 18 months
Number of High-Dose Steroid Treatment Courses
Number of courses of high-dose corticosteroid treatment documented after study enrollment, based on medical record review.
Measured: From enrollment through 18 months
Number of Emergency Department Visits
Number of emergency department visits documented after study enrollment, based on medical record review.
Measured: From enrollment through 18 months
Number of New Gadolinium-Enhancing MRI Lesions
Number of new gadolinium-enhancing lesions identified on standard-of-care MRI scans during follow-up.
Measured: Baseline through 18 months
Change in Blood Neurofilament Light Chain Level
Change in neurofilament light chain concentration measured in blood samples over follow-up.
Measured: Baseline through 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Relapse Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Oklahoma Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health
- Responsible party
- Principal investigator, Yang Mao-Draayer, Oklahoma Medical Research Foundation
- Investigators
- Yang Mao-Draayer, MD, PhD, Principal investigator, Oklahoma Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878923
- Sponsor's protocol ID
- ML46754
- Acronym
- STAT
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mancinelli CR, Rossi N, Capra R. Ocrelizumab for the Treatment of Multiple Sclerosis: Safety, Efficacy, and Pharmacology. Ther Clin Risk Manag. 2021 Jul 30;17:765-776. doi: 10.2147/TCRM.S282390. eCollection 2021.
PubMed 34354358Gelfand JM, Cree BAC, Hauser SL. Ocrelizumab and Other CD20+ B-Cell-Depleting Therapies in Multiple Sclerosis. Neurotherapeutics. 2017 Oct;14(4):835-841. doi: 10.1007/s13311-017-0557-4.
PubMed 28695471Wallin MT, Culpepper WJ, Campbell JD, Nelson LM, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Tremlett H, Buka SL, Dilokthornsakul P, Topol B, Chen LH, LaRocca NG; US Multiple Sclerosis Prevalence Workgroup. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019 Mar 5;92(10):e1029-e1040. doi: 10.1212/WNL.0000000000007035. Epub 2019 Feb 15.
PubMed 30770430Kornberg MD, Newsome SD. Unmasking and provoking severe disease activity in a patient with NMO spectrum disorder. Neurol Neuroimmunol Neuroinflamm. 2015 Feb 12;2(2):e66. doi: 10.1212/NXI.0000000000000066. eCollection 2015 Apr. No abstract available.
PubMed 25738165Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, Thompson AJ. Atlas of Multiple Sclerosis 2013: A growing global problem with widespread inequity. Neurology. 2014 Sep 9;83(11):1022-4. doi: 10.1212/WNL.0000000000000768. No abstract available.
PubMed 25200713Wu Q, Mills EA, Wang Q, Dowling CA, Fisher C, Kirch B, Lundy SK, Fox DA, Mao-Draayer Y; AMS04 Study Group. Siponimod enriches regulatory T and B lymphocytes in secondary progressive multiple sclerosis. JCI Insight. 2020 Feb 13;5(3):e134251. doi: 10.1172/jci.insight.134251.
PubMed 31935197Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.
PubMed 28002679Banwell B, Bennett JL, Marignier R, Kim HJ, Brilot F, Flanagan EP, Ramanathan S, Waters P, Tenembaum S, Graves JS, Chitnis T, Brandt AU, Hemingway C, Neuteboom R, Pandit L, Reindl M, Saiz A, Sato DK, Rostasy K, Paul F, Pittock SJ, Fujihara K, Palace J. Diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease: International MOGAD Panel proposed criteria. Lancet Neurol. 2023 Mar;22(3):268-282. doi: 10.1016/S1474-4422(22)00431-8. Epub 2023 Jan 24.
PubMed 36706773Bonnan M, Berthelot E, Cabre P. Multiple sclerosis-like NMOSD patients suffer severe worsening of status after fingolimod initiation. Mult Scler Relat Disord. 2021 Jul;52:102975. doi: 10.1016/j.msard.2021.102975. Epub 2021 Apr 24.
PubMed 33951589Harding KE, Wardle M, Carruthers R, Robertson N, Zhu F, Kingwell E, Tremlett H. Socioeconomic status and disability progression in multiple sclerosis: A multinational study. Neurology. 2019 Mar 26;92(13):e1497-e1506. doi: 10.1212/WNL.0000000000007190. Epub 2019 Feb 22.
PubMed 30796140Bourdette D, Patti F. US health insurance is an obstacle to disease-modifying treatments in MS. Neurology. 2016 Jul 26;87(4):346-7. doi: 10.1212/WNL.0000000000002904. Epub 2016 Jun 29. No abstract available.
PubMed 27358336Chalmer TA, Baggesen LM, Norgaard M, Koch-Henriksen N, Magyari M, Sorensen PS; Danish Multiple Sclerosis Group. Early versus later treatment start in multiple sclerosis: a register-based cohort study. Eur J Neurol. 2018 Oct;25(10):1262-e110. doi: 10.1111/ene.13692. Epub 2018 Jul 9.
PubMed 29847005Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.
PubMed 28002688Weinshenker BG, Bass B, Rice GP, Noseworthy J, Carriere W, Baskerville J, Ebers GC. The natural history of multiple sclerosis: a geographically based study. I. Clinical course and disability. Brain. 1989 Feb;112 ( Pt 1):133-46. doi: 10.1093/brain/112.1.133.
PubMed 2917275