Mechanism of Action of Ocrelizumab in Multiple Sclerosis
NCT ID: NCT03344094
Last Updated: 2025-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-02-23
2019-04-10
Brief Summary
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Detailed Description
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Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.
Conditions
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Study Design
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COHORT
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion 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.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB10681A
Identifier Type: -
Identifier Source: org_study_id
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