Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

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

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