Table 1: Baseline data (Safety Analysis population; n = 77).

Baseline data Group A TCZ plus MTX Group B TCZ plus placebo Total
n = 32 n = 33 n = 77a
Age 57.8 ± 11.9 57.2 ± 10.8 57.3 ± 10.9
Female 26 (81.3%) 25 (75.8%) 61 (79.2%)b
Body weight (kg; mean, min, max) 75.1 (52.0-120.0) 74.3 (52.0-112.2) 74.6 (52.0-120.0)
ESR (1st hour) ) 16.58 (± 12.25) 19.36 (± 10.26) 19.26 (± 12.15)
CRP (mg/dl) 1.25 (± 3.35) 1.15 (± 2.49) 1.42 (± 2.29)
RF pos. (%) 19 (63.3%) 22 (73.3%) 49 (68.1%)c
ACPA pos (%) 18 (60%) 20 (64.5%) 44 (69.3%)
DAS28 3.83 ± 0.51 3.94 ± 0.54 3.91 ± 0.54
VAS-Fatigue (mm) 35.59 ± 25.47 41.27 ± 28.17 39.26 ± 26.36
Patient's Assessment of Pain (VAS; mm) 39.41 ± 24.99 36.52 ± 24.40 39.47 ± 24.10
Patient's Global Assessment of Disease Activity (VAS; mm) 38.63 ± 19.79 38.24 ± 21.07 39.69 ± 19.98
Investigator's Global Assessment of Disease Activity (VAS; mm) 26.53 ± 12.35 25.09 ± 12.83 24.99 ± 12.20
CDAI 13.55 ± 4.52 12.70 ± 4.24 13.00 ± 4.38
SDAI 14.26 ± 4.35 13.26 ± 4.40 13.66 ± 4.31
HAQ-DI 0.81 ± 0.72 0.81 ± 0.55 0.85 ± 0.63
RADAI-5 4.17 ± 2.17 4.28 ± 1.86 4.29 ± 2.01
SF-12 Physical Standardised Value 41.13 ± 8.77 39.91 ± 7.14 40.09 ± 7.95
SF-12 Mental Standardised Value 47.22 ± 10.93 43.93 ± 11.38 45.18 ± 11.01
TSQM Effectiveness 55.11 ± 21.09 46.06 ± 23.58 49.66 ± 23.38
TSQM Side-Effects 98.61 ± 7.22 80.65 ± 29.99 88.25 ± 24.15
TSQM Convenience 86.01 ± 17.99 73.12 ± 23.66 76.45 ± 22.18
TSQM Global Satisfaction 64.81 ± 23.68 62.44 ± 28.33 62.58 ± 24.93

Except otherwise specified values are expressed as means ± SD; CDAI: Clinical Disease Activity Index; DAS28: Disease Activity Score 28; HAQ-DI: Health Assessment Questionnaire Disability Index; RF: Rheumatoid Factor; RADAI-5: Rheumatoid Arthritis Disease Activity Index 5; SDAI: Simplified Disease Activity Index; SF-12: 12-Item Short Form Health Survey; TSQM: Treatment Satisfaction Questionnaire for Medication; VAS: Visual Analogue Scale.

aNot randomised: n = 12, bNot randomised female: n = 10, cNot randomised RF pos: n = 7.