Mechanistic Study of Ocrevus

NCT04459988 | Completed FDA Drug

• 1 other identifier: HUM00066792
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Ocrevus; B cell; T cell; cytokines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in frequency of T cell subtypes

  From baseline to 24 months

Study Arms (2)

Patients with MS

Patients with MS who have been newly prescribed Ocrevus

Drug: Ocrelizumab

Healthy Controls

Healthy Controls

Interventions

Ocrelizumab DRUG

Description Needed

Also known as: Ocrevus

Patients with MS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS). Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline immune cell profiles. The patients and healthy controls will be recruited at the University of Michigan Neurology Clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be collected after 3, 6, 9, 12, 18 and 24 months of treatment.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yang Mao-Draayer, MD/PHD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology and Internal Medicine

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)