Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
NCT ID: NCT00844714
Last Updated: 2015-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2009-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituxan
Rituxan
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study
Interventions
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Rituxan
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study
Eligibility Criteria
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Inclusion Criteria
* Negative serum pregnancy test (for women of child bearing age)
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
* IgG \& IgM levels within normal limits
* Adequate renal function as indicated by serum creatinine measurements.
* No previous biological use (investigational or approved) except for the three approved anti-TNF alpha therapies
* Patients who have been treated with anti-TNF alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
* No use of phosphodiesterase type 5 inhibitors (PDE5) (i.e. Sildenafil, Tadalafil, and Vardenafil) 1 week prior to the study and during the course of the study.
* SBP ≤ 140/90 for two months prior to study enrollment
Exclusion Criteria
* Any serious concomitant medical condition that could interfere with the study.
* Patients with insulin dependent diabetes
* Failure to provide written consent.
* Individuals with HIV infections
* SBP \> 140/90 at two months prior to study enrollment
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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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.
Other Identifiers
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RITUXANFMD
Identifier Type: -
Identifier Source: org_study_id
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