Effects Of Prednisolone On Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00330889
First received: May 26, 2006
Last updated: October 18, 2012
Last verified: October 2012

May 26, 2006
October 18, 2012
February 2004
December 2006   (final data collection date for primary outcome measure)
  • Modified Disease Activity Score (DAS28), which was composed of swollen and tender joint counts at 28 sites, a patient's global assessment of disease activity using a visual analogue scale (VAS), and ESR. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • The levels of selected markers of inflammation, which could include (but were not limited to) ESR, C-reactive protein (CRP), interleukin-6 (IL-6), Rheumatoid factor (RF), and soluble tumor necrosis factor-receptor (TNF-R) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00330889 on ClinicalTrials.gov Archive Site
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Effects Of Prednisolone On Rheumatoid Arthritis Patients
A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients

This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.

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Observational
Time Perspective: Prospective
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Probability Sample

A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients and pharmacodynamic effects on whole blood gene and protein expression.

Arthritis, Rheumatoid
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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
32
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Meet the ACR criteria for diagnosis of rheumatoid arthritis.
  • Required treatment with Prednisolone.
  • Currently on a non-steroidal anti-inflammatory agent (NSAID).
  • Willing to stay on current dose of NSAID for two weeks during study.

Exclusion criteria:

  • Major health issues such as osteoporosis, diabetes, heart failure, heart attack, kidney failure, or acute infection.
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00330889
999920/040
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

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