Mechanism of Action of Ocrelizumab in Multiple Sclerosis

The University of Chicago

Status: Unknown

Conditions: Multiple Sclerosis; Immune System Diseases

Treatments: Drug: ocrelizumab

Study type: Observational

Funder types: Other

Identifiers

NCT03344094

IRB10681A

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 4 patient groups

MS-ocrelizumab treated

Description:

ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start

Treatment:

Drug: ocrelizumab

MS untreated

Description:

age- and sex-matched untreated MS controls

Healthy control

Description:

age- and sex-matched untreated healthy controls

MS interferon-treated

Description:

MS with ongoing interferon-beta therapy