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

Completed · Not applicable

Conditions studied: Endothelial Function, Rheumatoid Arthritis, Inflammation

In brief

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

Key facts

Study ID

NCT00844714

Run by

University of California, San Francisco

People needed

20

Starts

2009-11-01

Expected to finish

2014-12-01

Last updated by the study team

2015-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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