An observational study in Relapse Remitting Multiple Sclerosis, sponsored by Oklahoma Medical Research Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Oklahoma Medical Research Foundation · Observational
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.
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.
Oklahoma Medical Research Foundation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Participants With Relapsing Multiple Sclerosis (Rapid-Start and Delayed-Start Cohorts)
Inclusion Criteria:
Exclusion Criteria:
Healthy Control Participants
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Time frame: From baseline through 18 months of follow-up.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment through 18 months
Number of Emergency Department Visits
Number of emergency department visits documented after study enrollment, based on medical record review.
Time frame: 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.
Time frame: Baseline through 18 months
Change in Blood Neurofilament Light Chain Level
Change in neurofilament light chain concentration measured in blood samples over follow-up.
Time frame: Baseline through 18 months
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jun 2029, 33 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Charcot-Marie-Tooth disease, Type 1F
Oklahoma Medical Research Foundation