Overview

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