The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Prednisone 15 mg tablets once daily for 15 days.
Prednisone placebo tablets once daily for 15 days.
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
Synovial Blood Flow
Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.
Time frame: Baseline and Day 14
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) \& swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale \[VAS\]), and the CRP (in mg/L measured from lab test). The scoring formula was: DAS28(CRP) = 0.56\*SQR(TJC28) + 0.28\*SQR(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH(VAS) + 0.96. Where SQR is square root and ln is natural log. The formula produces a score from 0 to 10: \>5.1 means high disease activity; \<3.2 means low disease activity, \<2.6 is generally considered remission.
Time frame: Baseline and Day 14
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Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days