Mechanism of Action of Ocrelizumab in Multiple Sclerosis

NCT ID: NCT03344094

Last Updated: 2025-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-23

Study Completion Date

2019-04-10

Brief Summary

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Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.

Detailed Description

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The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.

Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.

Conditions

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Multiple Sclerosis Immune System Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MS-ocrelizumab treated

ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start

ocrelizumab

Intervention Type DRUG

FDA-approved MS drugs

MS untreated

age- and sex-matched untreated MS controls

No interventions assigned to this group

Healthy control

age- and sex-matched untreated healthy controls

No interventions assigned to this group

MS interferon-treated

MS with ongoing interferon-beta therapy

No interventions assigned to this group

Interventions

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ocrelizumab

FDA-approved MS drugs

Intervention Type DRUG

Other Intervention Names

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interferon-beta

Eligibility Criteria

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Inclusion Criteria

* All patients who are eligible for Ocrelizumab therapy based on FDA criteria

Exclusion Criteria

* All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
* Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests.
* Hepatitis B and HIV infections.
* Pregnant or lactating women.
* Hypersensitivity to trial medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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anthony t reder, md

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB10681A

Identifier Type: -

Identifier Source: org_study_id

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