Mechanism of Action of Ocrelizumab in Multiple Sclerosis

NCT03344094 | Completed Results FDA Drug

• 1 other identifier: IRB10681A
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Depletion of B Cells

  measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy Mononuclear cells (MNC) will be stained, for flow cytometry, with marker antibodies to B cells. The change in the percentage of each subset will be compared before and after treatment with paired t tests and ANOVA.

  1 year

Study Arms (4)

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

Drug: ocrelizumab

MS untreated

age- and sex-matched untreated MS controls

Healthy control

age- and sex-matched untreated healthy controls

MS interferon-treated

MS with ongoing interferon-beta therapy

Interventions

ocrelizumab DRUG

FDA-approved MS drugs

Also known as: interferon-beta

MS-ocrelizumab treated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS and healthy controls from the U of Chicago Neurology Clinic population

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen cells and serum

MeSH Terms

Conditions

Multiple Sclerosis; Immune System Diseases

Interventions

ocrelizumab; Interferon-beta

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: anthony t reder
• Organization: University of Chicago

areder@neurology.bsd.uchicago.edu

773-702-6204

Study Officials

• anthony t reder, md

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: November 17, 2017
• Study Start: February 23, 2018
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)