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OpenTrials
Completed

NCT Number: NCT03344094

Mechanism of Action of Ocrelizumab in Multiple Sclerosis

Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.

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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 Chicago

Chicago, Illinois, 60637, United States

About this study

The study will investigate immune cell subsets, and how the cells are modified by this therapy over a 1-year period in 25 subjects. Blood will be drawn at baseline, 2 weeks, 6 mo, and 12 mo.

Immune subsets will be analyzed by flow cytometry. Data are analyzed with ANOVA with repeated measures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients who are eligible for Ocrelizumab therapy based on FDA criteria

Exclusion criteria

  • All patients who are ineligible for Ocrelizumab therapy based on FDA criteria.
  • Prior treatment with Alemtuzumab or stem cell therapy, or immune abnormalities that would interfere with planned tests.
  • Hepatitis B and HIV infections.
  • Pregnant or lactating women.
  • Hypersensitivity to trial medications.

Treatment and study plan

Ocrelizumab

Drug

FDA-approved MS drugs

Other names: interferon-beta

Primary outcomes

  1. Number of Participants With Complete Depletion of B Cells

    Time frame: 1 year

    measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy Mononuclear cells (MNC) will be stained, for flow cytometry, with marker antibodies to B cells.

    The change in the percentage of each subset will be compared before and after treatment with paired t tests and ANOVA.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Feb 21, 2025

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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