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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Sclerosis | Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab |
| |
| Healthy | Healthy individuals serving as controls to the subjects with MS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling (MS) | Other | Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocyte Transcriptome Profiling | Changes in messenger ribonucleic acid (mRNA) expression | 12 months |
| Antigen microarrays | Changes in serum autoantibody immune signatures | 12 months |
| Serum microRNA profiles | Changes in serum microRNA expression | 12 months |
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Inclusion Criteria:
Exclusion Criteria - All subjects:
Exclusion Criteria - Healthy Controls:
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Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
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| Name | Affiliation | Role |
|---|---|---|
| Howard L Weiner, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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 |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum, plasma, and peripheral blood mononuclear cells.
| Blood sampling (controls) | Other | Blood samples will be collected once at enrollment. |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |