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Mechanism of Action of Ocrelizumab in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03344094
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
University of Chicago

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

Condition or disease Intervention/treatment
Multiple Sclerosis Immune System Diseases Drug: ocrelizumab

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanism of Action of Ocrelizumab in Multiple Sclerosis
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
MS-ocrelizumab treated
ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start
Drug: ocrelizumab
FDA-approved MS drugs
Other Name: interferon-beta

MS untreated
age- and sex-matched untreated MS controls
Healthy control
age- and sex-matched untreated healthy controls
MS interferon-treated
MS with ongoing interferon-beta therapy

Primary Outcome Measures :
  1. Immune subsets, measured through lymphocyte surface marker stains, from patients, before and after ocrelizumab (Ocrevus) therapy [ Time Frame: 1 year ]

    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.

Biospecimen Retention:   Samples With DNA
frozen cells and serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
MS and healthy controls from the U of Chicago Neurology Clinic population

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03344094

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Contact: anthony t reder, md 7737026204
Contact: mildred valentine, bs 7737029812

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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael r Ludwig, bs    773-702-8604   
Contact: sandra lieneck, bs    773-834-1811   
Sponsors and Collaborators
University of Chicago
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Principal Investigator: anthony t reder, md University of Chicago

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Responsible Party: University of Chicago Identifier: NCT03344094     History of Changes
Other Study ID Numbers: IRB10681A
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Multiple Sclerosis
Immune System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs