Table 1

Demographics and baseline disease characteristics

CharacteristicsMR prednisone (n=231)Placebo (n=119)
Demographic and disease characteristics
Age, years
Median (range)57.0 (27–80)58.0 (32–76)
Female sex, n (%)192 (83.1)102 (85.7)
White race, n (%)226 (97.8)118 (99.2)
BMI, mean±SD, kg/m228.0±5.828.1±5.5
Duration of RA
Mean (years)7.987.94
<2 Years, n (%)41 (17.7)29 (24.4)
Previous RA treatments, n (%)
DMARDs228 (98.7)*119 (100)
NSAIDs166 (71.9)88 (73.9)
Other analgesics84 (36.4)53 (44.5)
Biological treatments1 (0.4)1 (0.8)
ACR core set measures, mean±SD (unless stated)
Tender joint count12.6±6.1712.5±5.94
Swollen joint count8.4±4.408.6±4.65
Patient assessment of pain58 (3–96)51 (0–95)
Patient assessment of disease activity57.4±20.150.9±20.9
Physician assessment of disease activity55.2±16.154.1±17.4
HAQ-DI score1.3±0.61.3±0.6
CRP, mg/l5.2 (<0.05–91.5)5.3 (0.1–136.5)
ESR, mm/h32 (4–104)30 (2–115)
Other clinical end points, mean±SD
Duration of morning stiffness, min152.0±92.4156.7±87.7
Severity of morning stiffness54.6±21.750.7±21.3
Recurrence of stiffness, % of days68.3±39.072.1±37.3
Morning pain score54.9±21.650.5±22.4
Evening pain score49.9±23.547.8±21.9
Health-related quality of life, mean±SD
FACIT-F score28.8±10.428.7±10.7
SF-36 physical components summary score31.6±7.0§31.5±6.9
SF-36 mental components summary score45.3±10.7§45.4±9.6
Inflammatory markers, median (range)
IL-6, pg/ml<5 (<5–3215)<5 (<5–266)
TNFα, pg/ml<5 (<5–65)<5 (<5–15)
  • * Three patients in the MR prednisone group did not take DMARDs during the study, but they were not uncovered until unblinding.

  • Values in mm, measured using a 0–100 visual analogue scale.

  • Data presented as median (range).

  • § Data missing for two patients.

  • Data missing for one patient.

  • BMI, body mass index; CRP, C-reactive protein; DAS28, 28-joint Disease Activity Score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Functional Disability Index of the Health Assessment Questionnaire; IL-6, interleukin 6; MR, modified release; NSAID, non-steroidal anti-inflammatory drug; RA, rheumatoid arthritis; SF-36, 36-item Short-Form Health Survey; TNF, tumour necrosis factor.