Mechanistic Study of Ocrevus

Study Overview
=================
Brief 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.

Official Title
-----------------
Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Ocrelizumab


Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with MS<br>Patients with MS who have been newly prescribed Ocrevus | Drug: Ocrelizumab<br>* Description Needed<br>* Other names: Ocrevus;|
| Healthy Controls<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokines, Ocrevus, B cell, T cell