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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this investigation is to determine the effects of Rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituxan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituxan | Drug | 1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated Vasodilation (FMD) | endothelial function as assessed by flow-mediated vasodilation of the brachial artery | 12 weeks, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25336464 | Derived | Hsue PY, Scherzer R, Grunfeld C, Imboden J, Wu Y, Del Puerto G, Nitta E, Shigenaga J, Schnell Heringer A, Ganz P, Graf J. Depletion of B-cells with rituximab improves endothelial function and reduces inflammation among individuals with rheumatoid arthritis. J Am Heart Assoc. 2014 Oct 21;3(5):e001267. doi: 10.1161/JAHA.114.001267. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituxan | Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
per protocol, patients with active rheumatoid arthritis (RA) who had high levels of systemic inflammation
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituxan | Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Flow-mediated Vasodilation (FMD) | endothelial function as assessed by flow-mediated vasodilation of the brachial artery | Posted | Median | Inter-Quartile Range | percentage change in diameter | 12 weeks, 24 weeks |
|
|
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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 | Rituxan | Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priscilla Hsue, MD | University of California, San Francisco | 415-206-8257 | phsue@medsfgh.ucsf.edu |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Flow-mediated vasodilation (FMD) | endothelial function as assessed by flow-mediated vasodilation of the brachial artery | Median | Inter-Quartile Range | mm |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |