Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship
1 other identifier
interventional
51
5 countries
17
Brief Summary
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
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 Nov 2005
Shorter than P25 for phase_2
17 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
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 21, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedNovember 5, 2012
October 1, 2012
1 year
November 21, 2005
November 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C-reactive protein (CRP) levels 72 hours post-dose.
72 hours post-dose.
Secondary Outcomes (1)
C-reactive protein (CRP) levels 24 and 48 hours post-dose
24 and 48 hours post-dose
Interventions
Eligibility Criteria
You may qualify if:
- Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
- Must have 3 or more swollen or 3 or more tender/painful joints at screening.
- Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening.
You may not qualify if:
- Must not be morbidly obese.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (17)
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Sofia, 1233, Bulgaria
GSK Investigational Site
Sofia, 1431, Bulgaria
GSK Investigational Site
Erlangen, Bavaria, 91056, Germany
GSK Investigational Site
Munich, Bavaria, 80639, Germany
GSK Investigational Site
Hamburg, Hamburg, 21075, Germany
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, 24576, Germany
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41071, Spain
GSK Investigational Site
Linköping, SE-582 25, Sweden
GSK Investigational Site
Uppsala, SE-753 23, Sweden
GSK Investigational Site
Donetsk, 83045, Ukraine
GSK Investigational Site
Kharkiv, 61002, Ukraine
GSK Investigational Site
Kiev, 01030, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Lviv, 79010, Ukraine
Related Publications (1)
Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
PMID: 23254770DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2005
First Posted
November 22, 2005
Study Start
November 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
November 5, 2012
Record last verified: 2012-10