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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

August 24, 2005
October 9, 2008
June 2005
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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.
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.
Complete list of historical versions of study NCT00134693 on ClinicalTrials.gov Archive Site
Explore the relationship between the dose of SB-681323 and the dose of prednisolone that gives the same response in terms of CRP levels.
Explore the relationship between the dose of SB-681323 and the dose of prednisolone that gives the same response in terms of CRP levels.
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A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis
A Randomised, Placebo-Controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

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.
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Prednisolone
  • Drug: SB-681323
    Other Names:
    • Prednisolone
    • SB-681323
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France,   Germany,   Russian Federation,   United Kingdom
 
NCT00134693
RA1104046
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MB ChB GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP