A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.
1 other identifier
interventional
48
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJuly 2, 2012
June 1, 2012
1.9 years
September 21, 2006
June 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurment of synovial vascularity
Power Doppler ultrasonographic measurement of synovial vascularity
Day 1, Day 15 and Day 28
Secondary Outcomes (7)
Synovial thickness
Day 1, 15 and 28
Safety: ECG
Day 1, 15 and 28
Safety: Vital Signs
Day 1, 15 and 28
Safety: Laboratory
Day 1, 8, 15, 22, 28 and Follow Up
Pharmacokinetics: Cmax
Day 15 and Day 28
- +2 more secondary outcomes
Study Arms (3)
GW274150 60 mg once daily for 28 days
EXPERIMENTAL60 mg GW274150 taken once daily for 28 days
Prednisolone 7.5 mg once daily for 28 days
ACTIVE COMPARATOR7.5 mg prednisolone taken once daily for 28 days
Placebo once daily for 28 days
PLACEBO COMPARATORPlacebo taken once daily for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology
- Female subjects who are not capable of becoming pregnant
- Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal finger (MCP) joint with either detectable vascularity or thickness
- Stable doses of disease modifying anti-rheumatic drugs (DMARDs), (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrollment
- Patients receiving methotrexate must be on stable folate supplements
- Must have been on stable doses for 2 weeks prior to screening if using COX inhibitors
- Signed consent form
- The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
You may not qualify if:
- The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment
- The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
- The subject received their final dose of infliximab or adalimumab within 3 months of enrollment
- The subject received their final dose of etanercept or anakinra within 1 month of enrollment
- The subject has received another investigational drug within 30 days
- The subject drinks more than 28 units (male) or 21 units (female) of alcohol in a week
- History of liver or renal disease in the 6 months prior to screening
- The subject has a history of drug or other allergy
- Subject is positive for Hepatitis B and C or HIV virus
- The subject has positive pregnancy test
- The subject has positive test for drugs of abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Belgrade, 11000, Serbia
GSK Investigational Site
London, W6 8LH, United Kingdom
Related Publications (1)
Seymour M, Petavy F, Chiesa F, Perry H, Lukey PT, Binks M, Donatien PD, Freidin AJ, Eckersley RJ, McClinton C, Heath K, Prodanovic S, Radunovic G, Pilipovic N, Damjanov N, Taylor PC. Ultrasonographic measures of synovitis in an early phase clinical trial: a double-blind, randomised, placebo and comparator controlled phase IIa trial of GW274150 (a selective inducible nitric oxide synthase inhibitor) in rheumatoid arthritis. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):254-61. Epub 2012 Apr 13.
PMID: 22409880DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 25, 2006
Study Start
January 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
July 2, 2012
Record last verified: 2012-06