A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
NCT ID: NCT00379990
Last Updated: 2012-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2006-01-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GW274150 60 mg once daily for 28 days
60 mg GW274150 taken once daily for 28 days
GW274150
60 mg /day
Prednisolone 7.5 mg once daily for 28 days
7.5 mg prednisolone taken once daily for 28 days
Prednisolone
7.5 mg/day
Placebo once daily for 28 days
Placebo taken once daily for 28 days
Placebo
Placebo
Interventions
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GW274150
60 mg /day
Prednisolone
7.5 mg/day
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Belgrade, , Serbia
GSK Investigational Site
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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RA4104917
Identifier Type: -
Identifier Source: org_study_id
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