Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

NCT04466150 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: RO-IIS-2018-10828
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (1)

• Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab

  Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after 3 years of treatment with ocrelizumab. Intrathecal synthesis is measured by either a) normalization of the IgG Index (0.6 is the upper limit of normal) or b) eradication of oligoclonal bands

  3 years

Study Arms (2)

Ocrelizumab treated

ACTIVE COMPARATOR

Participants age 18-50 with a first clinical presentation of MS or high-risk CIS diagnosed within 90 days of screening will be treated with ocrelizumab (300 mg IV x 2 doses given 2 weeks apart) at disease origin and with maintenance ocrelizumab 600 mg every 6 months through 30 months with a final study visit at 3 years

Drug: Ocrelizumab

Observational study cohort

NO INTERVENTION

Subjects enrolled into an observational study matched for the same disease duration and who are either untreated or treated with alternate MS disease modifying therapies will serve as a parallel reference group

Interventions

Ocrelizumab DRUG

open label biomarker study

Also known as: Ocrevus

Ocrelizumab treated

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tube ligation, male sterilization, established hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.
• Examples of barrier methods supplemented with the use of spermicide include male or female condom, cap, diaphragm, or sponge.

You may not qualify if:

• 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
• Hypersensitivity to trial medications
• History of life-threatening infusion reaction to MAbs

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator
• Valhalla Foundation: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Interventions

ocrelizumab

Study Officials

• Bruce Cree, MD, PhD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a nested case-controlled study. By nesting this ocrelizumab interventional treatment arm within an observational study, the investigators will be able to compare treatment with ocrelizumab to usual care for patients who are matched for the same disease duration. Because the same clinical and biomarker assessments will be acquired for both the ocrelizumab interventional arm and the usual care observational cohort, this study will allow direct comparison of ocrelizumab with a usual care control group.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: August 30, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Clinical study report to Sponsor estimated May 2025. Other data/samples will be shared after initial results are published and on a case by case basis.
• Access Criteria: Collaborators, other scientific Investigators, Government Health and research agencies, Commercial Companies may request data and/or samples. The request process includes submitting a research proposal, having necessary IRB approval and material transfer agreements.

Locations

US (1)