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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

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