Mechanism of Action of Ocrelizumab in Multiple Sclerosis
- Registration Number
- NCT03344094
- Lead Sponsor
- University of Chicago
- Brief Summary
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- All patients who are eligible for Ocrelizumab therapy based on FDA 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MS-ocrelizumab treated ocrelizumab ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start
- Primary Outcome Measures
Name Time Method Number of Participants With Complete Depletion of B Cells 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States