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
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis Immune System Diseases||Drug: ocrelizumab|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start
FDA-approved MS drugs
Other Name: interferon-beta
age- and sex-matched untreated MS controls
age- and sex-matched untreated healthy controls
MS with ongoing interferon-beta therapy
- 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
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
|Contact: anthony t reder, email@example.com|
|Contact: mildred valentine, firstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Michael r Ludwig, bs 773-702-8604 email@example.com|
|Contact: sandra lieneck, bs 773-834-1811 firstname.lastname@example.org|
|Principal Investigator:||anthony t reder, md||University of Chicago|