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

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: GW856553	Phase II

Further study details as provided by GlaxoSmithKline:

Primary Outcomes: Determine dose-response relationship for a range of doses (7.5, 20 and 60mg) of GW856553 on levels of a blood protein (CRP) associated with rheumatoid arthritis
Secondary Outcomes: Determine plasma drug concentrations to allow characterisation of the action of the body on the drug.
Expected Total Enrollment:  48

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00256919

GSK Clinical Trials Call Center: Refer to study "RA3 103730"      1-877-379-3718 

Bulgaria
      GSK Clinical Trials Call Centre, Sofia,  1621,  Bulgaria
      GSK Clinical Trials Call Centre, Sofia,  1621,  Bulgaria
      GSK Clinical Trials Call Centre, Sofia,  1233,  Bulgaria
Germany
      GSK Clinical Trials Call Centre, Bad Bramstedt,  24576,  Germany
      GSK Clinical Trials Call Centre, Erlangen,  91056,  Germany
      GSK Clinical Trials Call Centre, Muenchen,  80331,  Germany
Spain
      GSK Clinical Trials Call Centre, Santiago de Compostela,  15706,  Spain
      GSK Clinical Trials Call Centre, Sevilla,  41071,  Spain
      GSK Clinical Trials Call Centre, Madrid,  28046,  Spain
Sweden
      GSK Clinical Trials Call Centre, Uppsala,  S-753 23,  Sweden
      GSK Clinical Trials Call Centre, Lulea,  S-972 33,  Sweden
      GSK Clinical Trials Call Centre, Linkoeping,  S-582 25,  Sweden

Study chairs or principal investigators

GSK Clinical Trials, MB ChB,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  RA3103730
Last Updated:  December 8, 2005
Record first received:  November 21, 2005
ClinicalTrials.gov Identifier:  NCT00256919
Health Authority: Sweden: Medical Products Agency; Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2006-01-10