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

University of California San Francisco (UCSF)

Status

Completed

Conditions

Endothelial Function

Inflammation

Rheumatoid Arthritis

Treatments

Drug: Rituxan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00844714

RITUXANFMD

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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