Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Francisco
With
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
