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Effects Of Prednisolone On Rheumatoid Arthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330889
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease
Arthritis, Rheumatoid

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Study Type : Observational
Actual Enrollment : 32 participants
Time Perspective: Prospective
Official Title: A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients
Study Start Date : February 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330889


Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35249
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90095
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68198
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A-1M4
United Kingdom
GSK Investigational Site
Sheffield, United Kingdom, S10 2RX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00330889    
Other Study ID Numbers: 999920/040
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012
Keywords provided by GlaxoSmithKline:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases