This trial is active, not recruiting.

Conditions endothelial function, rheumatoid arthritis, inflammation
Treatment rituxan
Target CD20
Sponsor University of California, San Francisco
Collaborator Genentech
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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study

Primary Outcomes

Flow-mediated Vasodilation (FMD)
time frame: 12 weeks, 24 weeks

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.