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Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256919
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : November 5, 2012
Information provided by (Responsible Party):

Brief Summary:
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: GW856553 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2005
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. C-reactive protein (CRP) levels 72 hours post-dose. [ Time Frame: 72 hours post-dose. ]

Secondary Outcome Measures :
  1. C-reactive protein (CRP) levels 24 and 48 hours post-dose [ Time Frame: 24 and 48 hours post-dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256919

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GSK Investigational Site
Plovdiv, Bulgaria, 4000
GSK Investigational Site
Sofia, Bulgaria, 1233
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Erlangen, Bayern, Germany, 91056
GSK Investigational Site
Muenchen, Bayern, Germany, 80639
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Hamburg, Germany, 21075
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Linkoeping, Sweden, SE-582 25
GSK Investigational Site
Uppsala, Sweden, SE-753 23
GSK Investigational Site
Donetsk, Ukraine, 83045
GSK Investigational Site
Kharkiv, Ukraine, 61002
GSK Investigational Site
Kiev, Ukraine, 01030
GSK Investigational Site
Kyiv, Ukraine, 03680
GSK Investigational Site
Lviv, Ukraine, 79010
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline Identifier: NCT00256919    
Other Study ID Numbers: RA3103730
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: October 2012
Keywords provided by GlaxoSmithKline:
rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases