Mechanistic Study of Ocrevus

Multiple Sclerosis Clinical Trial

Official title:

Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459988
• Other study ID #: HUM00066792
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: October 25, 2022

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Ocrelizumab
Description Needed

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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