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Mechanism of Action of Ocrelizumab in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03344094
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03344094


Contacts
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Contact: anthony t reder, md 7737026204 areder@neurology.bsd.uchicago.edu
Contact: mildred valentine, bs 7737029812 mvalenti@neurology.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael r Ludwig, bs    773-702-8604    io-ura@lists.uchicago.edu   
Contact: sandra lieneck, bs    773-834-1811    sleineck@neurology.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: anthony t reder, md University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov 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
Sclerosis
Immune System Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Interferons
Interferon-beta
Ocrelizumab
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs