Mechanistic Study of Ocrevus

NCT ID: NCT04459988

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-10-25

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MS

Patients with MS who have been newly prescribed Ocrevus

Ocrelizumab

Intervention Type DRUG

Description Needed

Healthy Controls

Healthy Controls

No interventions assigned to this group

Interventions

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Ocrelizumab

Description Needed

Intervention Type DRUG

Other Intervention Names

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Ocrevus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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David A. Fox, MD

Professor of Rheumatology and Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Mao-Draayer, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00066792

Identifier Type: -

Identifier Source: org_study_id

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