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OpenTrials
Completed

NCT Number: NCT04459988

Mechanistic Study of Ocrevus

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Drug

Description Needed

Other names: Ocrevus

Primary outcomes

  1. Change in frequency of regulatory B cells

    Time frame: From baseline to 24 months

    Percentage B cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls

Secondary outcomes

  1. Change in frequency of T cell subtypes

    Time frame: From baseline to 24 months

    Percentage of T cells measured by flow cytometry. Compare Ocrevus treatment to baseline and to healthy controls

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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