Mechanistic Study of Ocrevus

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04459988

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Ocrelizumab

Study Design

Study Type:

Observational

Anticipated Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Patients with MS

Patients with MS who have been newly prescribed Ocrevus

Drug: Ocrelizumab

Description Needed

Other Names:

Ocrevus

Healthy Controls

Outcome Measures

Primary Outcome Measures

Change in frequency of regulatory B cells [From baseline to 24 months]
Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls

Secondary Outcome Measures

Change in frequency of T cell subtypes [From baseline to 24 months]
Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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