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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00330889 |
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Date of registration:
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26/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects Of Prednisolone On Rheumatoid Arthritis Patients
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Scientific title:
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A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00330889 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Canada
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United Kingdom
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
25 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Primary Outcome(s)
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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]
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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]
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Secondary ID(s)
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999920/040
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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