Back to resultsSingle Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW856553
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring GW856553, biomarkers, CRP, rheumatoid arthritis
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: Must not be morbidly obese.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
C-reactive protein (CRP) levels 72 hours post-dose.
Secondary Outcome Measures
C-reactive protein (CRP) levels 24 and 48 hours post-dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00256919
Brief Title
Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
GW856553, biomarkers, CRP, rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW856553
Primary Outcome Measure Information:
Title
C-reactive protein (CRP) levels 72 hours post-dose.
Time Frame
72 hours post-dose.
Secondary Outcome Measure Information:
Title
C-reactive protein (CRP) levels 24 and 48 hours post-dose
Time Frame
24 and 48 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
Must not be morbidly obese.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91056
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80639
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Bramstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
24576
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
GSK Investigational Site
City
Linkoeping
ZIP/Postal Code
SE-582 25
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-753 23
Country
Sweden
Facility Name
GSK Investigational Site
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kiev
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
23254770
Citation
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.
Results Reference
derived
Learn more about this trial
Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
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