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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: April 15, 2015
Last verified: April 2015

August 24, 2005
April 15, 2015
June 2005
August 2006   (final data collection date for primary outcome measure)
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.
Same as current
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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: Prednisolone
  • Drug: SB-681323
    Other Name: Prednisolone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
August 2006
August 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   France,   Germany,   Russian Federation,   United Kingdom
 
NCT00134693
RA1104046
Yes
Not Provided
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2015

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