Status:
COMPLETED
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Endothelial Function
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00844714
Start Date
November 1 2009
End Date
December 1 2014
Last Update
June 26 2015
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94110