Immune System Diseases, Multiple Sclerosis
Conditions
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.
Interventions
DRUGocrelizumab
FDA-approved MS drugs
Sponsors
University of Chicago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
began 2-23-2018; filled 3-9-2018
Pre-assignment details
not needed
Participants by arm
| Arm | Count |
|---|---|
| MS-ocrelizumab Treated ocrelizumab 600 mg IV over 5 hours, twice a year, with loading dose of 300 mg 2 weeks apart x 2 at start
ocrelizumab: FDA-approved MS drugs | 15 |
| MS Untreated age- and sex-matched untreated MS controls | 5 |
| Healthy Control age- and sex-matched untreated healthy controls | 5 |
| MS Interferon-treated MS with ongoing interferon-beta therapy | 5 |
| Total | 30 |
Baseline characteristics
| Characteristic | MS Untreated | Healthy Control | MS Interferon-treated | MS-ocrelizumab Treated | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 12 Participants | 27 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 14.8 | 55.1 years STANDARD_DEVIATION 13.7 | 41.8 years STANDARD_DEVIATION 2.5 | 47.7 years STANDARD_DEVIATION 14.3 | 48.4 years STANDARD_DEVIATION 13.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 4 Participants | 9 Participants | 22 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 3 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 2 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 15 | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 15 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
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
Population: The MS-ocrelizumab treated group was analyzed for depletion of B cells, whereas MS-untreated, healthy controls and MS interferon-treated groups were not analyzed for depletion of B cells.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MS-ocrelizumab Treated | Number of Participants With Complete Depletion of B Cells | 15 Participants |
| MS Untreated | Number of Participants With Complete Depletion of B Cells | 0 Participants |
| Healthy Control | Number of Participants With Complete Depletion of B Cells | 0 Participants |
| MS Interferon-treated | Number of Participants With Complete Depletion of B Cells | 0 Participants |
p-value: 0.05ANOVA