Mechanistic Study of Ocrevus

Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis

The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS). Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline immune cell profiles. The patients and healthy controls will be recruited at the University of Michigan Neurology Clinic.

Description

Inclusion Criteria:

Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment

OR

Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.

• Ability to give informed consent
• Willing to have blood drawn as scheduled in the protocol
• Willing and able to complete all procedures and evaluations related to the study

Exclusion Criteria:

• Medical or psychiatric conditions that may affect the patient's ability to give informed consent
• Has received an experimental drug within 30 days of enrollment
• Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
• Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
• Active hepatitis B virus infection
• History of life-threatening infusion reaction to Rituxan or Ocrevus
• Chronic infection or any severe acute infection within 3 months prior to screening

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with MS; Patients with MS who have been newly prescribed Ocrevus	Drug: Ocrelizumab; Description Needed; Other Names: Ocrevus
Healthy Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of regulatory B cells	Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls	From baseline to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of T cell subtypes	Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls	From baseline to 24 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Yang Mao-Draayer, MD/PHD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Ocrevus; cytokines; T cell; B cell
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Immunologic Factors; Ocrelizumab
• Other Study ID Numbers: HUM00066792

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.: No