Multiple Sclerosis Clinical Trial

Mechanistic Study of Ocrevus

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Estimated Enrollment:

35

Study ID:

NCT04459988

Recruitment Status:

Completed

Sponsor:

University of Michigan

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There is 1 Location for this study

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University of Michigan
Ann Arbor Michigan, 48109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

35

Study ID:

NCT04459988

Recruitment Status:

Completed

Sponsor:


University of Michigan

How clear is this clinincal trial information?

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