Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00256919
First received: November 21, 2005
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256919

Locations
Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria, 4000
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Sofia, Bulgaria, 1233
Germany
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
Spain
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41071
Sweden
GSK Investigational Site
Linkoeping, Sweden, SE-582 25
GSK Investigational Site
Uppsala, Sweden, SE-753 23
Ukraine
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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:
GW856553
biomarkers
CRP
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013