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Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE4

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

NCT04466150•University of California, San Francisco

Summary

Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients will be treated with ocrelizumab at disease onset to see if treatment favorably alters CSF markers of chronic inflammation.

Detailed Description

Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients age 18-50 will be treated with ocrelizumab within 90 days of first clinical MS/CIS presentation and re-dosed as maintenance therapy every 6 months for 3 years to see if treatment favorably alters CSF markers of chronic inflammation Investigators hope data that will provide a foundation for further studies that treating relapsing MS patients at clinical onset (using a B-cell depleting therapy) may improve longer-term outcomes.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet the following criteria to be included in this study:
•Signed Consent Form
•High-risk clinically isolated syndrome or relapsing MS Diagnosis (based on 2017 International Panel Criteria)
•Age 18-50 inclusive
•Screening within 90 days of first clinical demyelinating event typical of MS with 1 or more inactive lesions typical of MS
•No prior MS disease modifying therapy
•No corticosteroids within 7 days of first ocrelizumab treatment
•EDSS \< 4.0
•A negative urine or serum pregnancy test must be available for premenopausal women and for women \<12 months after the onset of menopause, unless they have undergone surgical sterilization.
•Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use one method of contraception with a failure rate of \<1% per year or a barrier method supplemented with spermicide. Contraception must continue for the duration of study treatment and for at least 24 weeks after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause of other than menopause), and has not undergone surgical sterilization (removal of the ovaries and/or uterus).
+3 more criteria

Exclusion Criteria

•Patients will be excluded from the study based on the following criteria:
•Pregnancy, lactation, or intention to become pregnant during the study
•Progressive MS (primary or secondary)
•Disease other than MS to explain the first demyelinating event; including AQP4 IgG seropositivity
•Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator
•Unwilling or unsafe to proceed with MRI
•Active hepatitis B virus infection
•Untreated latent or active tuberculosis
•Active hepatitis C virus infection
•HIV infection
+2 more criteria

Locations (1)

University of California San Francisco

San Francisco, California, United States

Key Dates

Start Date

August 30, 2020

Primary Completion Date

December 1, 2026

Completion Date

July 1, 2027

Last Updated

January 26, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsing Multiple SclerosisClinically Isolated Syndrome

Interventions

Ocrelizumab

DRUG

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

NCT07426991

Multiple SclerosisRemitting-Relapsing Multiple Sclerosis+4 more

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RECRUITING

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

NCT06433752

Relapsing Multiple SclerosisMultiple Sclerosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

Inclusion Criteria

Exclusion Criteria

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

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