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A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 24, 2005
Last updated: May 24, 2017
Last verified: May 2017
This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

Condition Intervention Phase
Arthritis, Rheumatoid Drug: Prednisolone Drug: SB-681323 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Determine dose-response relationship for a a range of doses (7.5 to 25mg) of SB-681323 on levels of a blood protein (CRP)associated with RA. Levels of CRP 72 hours after dosing.

Secondary Outcome Measures:
  • Explore the relationship between the dose of SB-681323 and the dose of prednisolone that gives the same response in terms of CRP levels.

Enrollment: 77
Study Start Date: June 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Prednisolone Drug: SB-681323
    Other Name: Prednisolone

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  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: NCT00134693

Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
GSK Investigational Site
Douglas, Queensland, Australia, 4814
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Australia, Western Australia
GSK Investigational Site
Shenton Park, Western Australia, Australia, 6008
GSK Investigational Site
Amiens, Picardie, France, 80054
GSK Investigational Site
Montpellier Cedex 5, France, 34295
GSK Investigational Site
Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78054
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09111
GSK Investigational Site
Leipzig, Sachsen, Germany, 04107
GSK Investigational Site
Leipzig, Sachsen, Germany, 04229
GSK Investigational Site
Berlin, Germany, 12163
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 14059
GSK Investigational Site
Berlin, Germany, 14109
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620102
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L9 7AL
GSK Investigational Site
Newcastle, Northumberland, United Kingdom, NE1 4LP
GSK Investigational Site
Oxford, United Kingdom, OX3 7LP
GSK Investigational Site
Sheffield, United Kingdom, S10 2RX
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00134693     History of Changes
Other Study ID Numbers: RA1104046
Study First Received: August 24, 2005
Last Updated: May 24, 2017

Keywords provided by GlaxoSmithKline:
SB-681323 rheumatoid arthritis CRP biomarkers

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on June 23, 2017