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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| MS untreated | age- and sex-matched untreated MS controls | ||
| Healthy control | age- and sex-matched untreated healthy controls | ||
| MS interferon-treated | MS with ongoing interferon-beta therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocrelizumab | Drug | FDA-approved MS drugs |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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MS and healthy controls from the U of Chicago Neurology Clinic population
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| Name | Affiliation | Role |
|---|---|---|
| anthony t reder, md | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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not needed
began 2-23-2018; filled 3-9-2018
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | MS Untreated | age- and sex-matched untreated MS controls |
| FG002 | Healthy Control | age- and sex-matched untreated healthy controls |
| FG003 | MS Interferon-treated | MS with ongoing interferon-beta therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | MS Untreated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 1 year |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| anthony t reder | University of Chicago | 773-702-6204 | areder@neurology.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2010 | May 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2019 | Mar 23, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
| D016899 | Interferon-beta |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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frozen cells and serum
age- and sex-matched untreated MS controls
| BG002 | Healthy Control | age- and sex-matched untreated healthy controls |
| BG003 | MS Interferon-treated | MS with ongoing interferon-beta therapy |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Chicago metropolitan area | Number | participants |
|
| OG001 | MS Untreated | age- and sex-matched untreated MS controls all enrolled |
| OG002 | Healthy Control | age- and sex-matched untreated healthy controls all enrolled |
| OG003 | MS Interferon-treated | MS with ongoing interferon-beta therapy all enrolled |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | MS Untreated | age- and sex-matched untreated MS controls | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Healthy Control | age- and sex-matched untreated healthy controls | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | MS Interferon-treated | MS with ongoing interferon-beta therapy | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001327 | Autoimmune Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |