Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 21, 2005
Last updated: November 1, 2012
Last verified: October 2012

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

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: GW856553
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 51
Study Start Date: November 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW856553
    Other Name: GW856553

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00256919

GSK Investigational Site
Plovdiv, Bulgaria, 4000
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Sofia, Bulgaria, 1233
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
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00256919     History of Changes
Other Study ID Numbers: RA3103730
Study First Received: November 21, 2005
Last Updated: November 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 25, 2014