Mechanistic Study of Ocrevus

University of Michigan

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Ocrelizumab

Study type: Observational

Funder types: Other

Identifiers

NCT04459988

HUM00066792

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Patients with MS

Description:

Patients with MS who have been newly prescribed Ocrevus

Treatment:

Drug: Ocrelizumab

Healthy Controls

Description:

Healthy Controls