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Mechanism of Action of Ocrelizumab in Multiple Sclerosis

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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

Trial contacts and locations

1

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Central trial contact

anthony t reder, md; mildred valentine, bs

Data sourced from clinicaltrials.gov

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