A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
Phase 2
Completed
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Registration Number
- NCT00379990
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GW274150 60 mg once daily for 28 days GW274150 60 mg GW274150 taken once daily for 28 days Prednisolone 7.5 mg once daily for 28 days Prednisolone 7.5 mg prednisolone taken once daily for 28 days Placebo once daily for 28 days Placebo Placebo taken once daily for 28 days
- Primary Outcome Measures
Name Time Method Measurment of synovial vascularity Day 1, Day 15 and Day 28 Power Doppler ultrasonographic measurement of synovial vascularity
- Secondary Outcome Measures
Name Time Method Synovial thickness Day 1, 15 and 28 High frequency ultrasound measurement of synovial thickness
Safety: ECG Day 1, 15 and 28 12-lead ECG meaurements
Safety: Vital Signs Day 1, 15 and 28 Blood pressure and heart rate
Safety: Laboratory Day 1, 8, 15, 22, 28 and Follow Up Laboratory assessments including liver function tests, amylase and lipase
Pharmacokinetics: Cmax Day 15 and Day 28 Maximum plasma concentration of GW274150
Pharmacokinetics: Trough Days 8,15 and Day 28 Trough plasma concentration of GW274150
Tolerability Day 1 to Day 28 and Follow Up Adverse events
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom