Mechanism of Action of Ocrelizumab in Multiple Sclerosis

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

Study Overview

• Status: Unknown
• Conditions: Immune System Diseases; Multiple Sclerosis
• Intervention / Treatment: Drug: ocrelizumab

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: anthony t reder, md; Phone Number: 7737026204; Email: areder@neurology.bsd.uchicago.edu
• Study Contact Backup: Name: mildred valentine, bs; Phone Number: 7737029812; Email: mvalenti@neurology.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Michael r Ludwig, bs; Phone Number: 773-702-8604; Email: io-ura@lists.uchicago.edu
      • Contact: sandra lieneck, bs; Phone Number: 773-834-1811; Email: sleineck@neurology.bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; FDA-approved MS drugs; Other Names: interferon-beta
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune subsets, 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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: anthony t reder, md, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Immune System Diseases; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Ocrelizumab; Interferon-beta
• Other Study ID Numbers: IRB10681A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes