This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
GSK Investigational Site
Belgrade, Serbia
GSK Investigational Site
London, United Kingdom
Measurment of synovial vascularity
Power Doppler ultrasonographic measurement of synovial vascularity
Time frame: Day 1, Day 15 and Day 28
Synovial thickness
High frequency ultrasound measurement of synovial thickness
Time frame: Day 1, 15 and 28
Safety: ECG
12-lead ECG meaurements
Time frame: Day 1, 15 and 28
Safety: Vital Signs
Blood pressure and heart rate
Time frame: Day 1, 15 and 28
Safety: Laboratory
Laboratory assessments including liver function tests, amylase and lipase
Time frame: Day 1, 8, 15, 22, 28 and Follow Up
Pharmacokinetics: Cmax
Maximum plasma concentration of GW274150
Time frame: Day 15 and Day 28
Pharmacokinetics: Trough
Trough plasma concentration of GW274150
Time frame: Days 8,15 and Day 28
Tolerability
Adverse events
Time frame: Day 1 to Day 28 and Follow Up
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