Arthritis, Rheumatoid Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 75 Years |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Winnipeg | Manitoba |
United Kingdom | GSK Investigational Site | Sheffield | |
United States | GSK Investigational Site | Birmingham | Alabama |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Canada, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 14 days | No | |
Primary | 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) | 14 days | No |
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