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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04459988
Other study ID # HUM00066792
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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