Last updated: 11/04/2018 04:17:24
Effects Of Prednisolone On Rheumatoid Arthritis Patients
GSK study ID
999920/040
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients
Trial description: This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: 14 days
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)
Timeframe: 14 days
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
32
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Arthritis, Rheumatoid
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2004 to December 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
25 - 75 years
Accepts healthy volunteers
No
- Meet the ACR criteria for diagnosis of rheumatoid arthritis.
- Required treatment with Prednisolone.
- Major health issues such as osteoporosis, diabetes, heart failure, heart attack, kidney failure, or acute infection.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35249
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-04-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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