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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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00134693
First received: August 24, 2005
Last updated: October 9, 2008
Last verified: October 2008
History of Changes
  Purpose

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
Rheumatoid Arthritis
 Drug: Prednisolone
Drug: SB-681323
 Phase 2

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

U.S. FDA Resources

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.

Estimated Enrollment: 77
Study Start Date: June 2005
Intervention Details:
    Drug: Prednisolone Drug: SB-681323
    Other Names:
    • Prednisolone
    • SB-681323
  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 â " 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: NCT00134693

Locations
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
France
GSK Investigational Site
Amiens, Picardie, France, 80054
GSK Investigational Site
Montpellier Cedex 5, France, 34295
Germany
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, 04229
GSK Investigational Site
Leipzig, Sachsen, Germany, 04107
GSK Investigational Site
Berlin, Germany, 12163
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 14109
GSK Investigational Site
Berlin, Germany, 14059
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 2GG
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MB ChB GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00134693     History of Changes
Other Study ID Numbers: RA1104046
Study First Received: August 24, 2005
Last Updated: October 9, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 23, 2013