An observational study in Multiple Sclerosis and Immune System Diseases, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by University of Chicago · Observational
Ocrelizumab is FDA approved for therapy of multiple sclerosis (MS). It depletes B cells and stops MS inflammation.
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.
MS and healthy controls from the U of Chicago Neurology Clinic population
Exclusion Criteria:
ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start
Drug: ocrelizumab
age- and sex-matched untreated MS controls
age- and sex-matched untreated healthy controls
MS with ongoing interferon-beta therapy
FDA-approved MS drugs
Also known as: interferon-beta
Number of Participants With Complete Depletion of B Cells
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.
Time frame: 1 year
began 2-23-2018; filled 3-9-2018
| Milestone | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated |
|---|---|---|---|---|
| Started | 15 | 5 | 5 | 5 |
| Completed | 15 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Participants | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated |
|---|---|---|---|---|
| Number of Participants With Complete Depletion of B Cells | 15 | 0 | 0 | 0 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MS-ocrelizumab Treated | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| MS Untreated | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Healthy Control | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| MS Interferon-treated | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 5 | 5 | 5 | 27 |
| >=65 years | 3 | 0 | 0 | 0 | 3 |
| Age, Continuous(years) | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated | Total |
|---|---|---|---|---|---|
| Mean | 47.7 ± 14.3 | 48.5 ± 14.8 | 55.1 ± 13.7 | 41.8 ± 2.5 | 48.4 ± 13.8 |
| Sex: Female, Male(Participants) | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated | Total |
|---|---|---|---|---|---|
| Female | 10 | 4 | 1 | 3 | 18 |
| Male | 5 | 1 | 4 | 2 | 12 |
| Race (NIH/OMB)(Participants) | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 3 | 1 | 0 | 1 | 5 |
| White | 9 | 4 | 5 | 4 | 22 |
| More than one race | 2 | 0 | 0 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | MS-ocrelizumab Treated | MS Untreated | Healthy Control | MS Interferon-treated | Total |
|---|---|---|---|---|---|
| United States | 15 | 5 | 5 | 5 | 30 |
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University of Chicago