A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients
N/A
25 Years
75 Years
25 Years
75 Years
Not Enrolling
Both
Arthritis, Rheumatoid
Both
Arthritis, Rheumatoid
Trial Information
A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients
Inclusion 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.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
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.
Outcome Time Frame:
14 days
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
999920/040
NCT ID:
NCT00330889
Start Date:
February 2004
Completion Date:
December 2006
Related Keywords:
- Arthritis, Rheumatoid
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Birmingham, Alabama 35209 |
| GSK Investigational Site | Omaha, Nebraska 68131 |
