Endothelial Function, Inflammation, Rheumatoid Arthritis
Conditions
Keywords
endothelial function, rheumatoid arthritis, cardiovascular risk, rituxan therapy
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
Interventions
DRUGRituxan
1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study
Sponsors
Genentech, Inc.
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated Vasodilation (FMD) | 12 weeks, 24 weeks | endothelial function as assessed by flow-mediated vasodilation of the brachial artery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituxan Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Rituxan |
|---|---|
| Age, Continuous | 54 years |
| Flow-mediated vasodilation (FMD) | 3.9 mm |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Flow-mediated Vasodilation (FMD)
endothelial function as assessed by flow-mediated vasodilation of the brachial artery
Time frame: 12 weeks, 24 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Rituxan | Flow-mediated Vasodilation (FMD) | 24 weeks | 4.4 percentage change in diameter |
| Rituxan | Flow-mediated Vasodilation (FMD) | 12 weeks | 6.1 percentage change in diameter |