Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
This trial is active, not recruiting.
|Conditions||endothelial function, rheumatoid arthritis, inflammation|
|Sponsor||University of California, San Francisco|
|Start date||November 2009|
|End date||December 2012|
|Trial size||20 participants|
|Trial identifier||NCT00844714, RITUXANFMD|
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
|Intervention model||single group assignment|
Flow-mediated Vasodilation (FMD)
time frame: 12 weeks, 24 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: - Able and willing to give written informed consent and comply with the requirements of the study protocol - 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: - Prior history of MI, CVA, CABG, PTCA, or peripheral vascular disease - 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
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