Mechanism of Action of Ocrelizumab in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Mechanism of Action of Ocrelizumab in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03344094
• Other study ID #: IRB10681A
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2017
• Last updated: November 14, 2017
• Start date: October 12, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: University of Chicago
• Contact: anthony t reder, md
• Phone: 7737026204
• Email: areder[@]neurology.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune System Diseases
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• ocrelizumab
FDA-approved MS drugs

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune subsets, 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.	1 year