| 8 mg/kg Tocilizumab + methotrexate (n = 170) | 4 mg/kg Tocilizumab + methotrexate (n = 161) | Placebo + methotrexate (n = 158) | |
| Age, years (SD) | 53.9 (12.7) | 50.9 (12.5) | 53.4 (13.3) |
| % Female | 84 | 81 | 79 |
| Disease duration, years (SD) | 12.6 (9.3) | 11.0 (8.5) | 11.4 (9.2) |
| No of previous anti-TNF | |||
| 1 (%) | 50 | 47 | 42 |
| 2 (%) | 32 | 41 | 44 |
| >3 (%) | 18 | 12 | 14 |
| Previous anti-TNF therapy (%) | |||
| Etanercept | 38.3 | 38.0 | 30.6 |
| Adalimumab | 30.3 | 34.4 | 39.4 |
| Infliximab | 31.4 | 26.4 | 29.4 |
| No of previous DMARD (SD) | 1.9 (1.7) | 2.0 (1.6) | 2.1 (1.6) |
| Baseline methotrexate dose, mg/week (SD) | 15.7 (4.4) | 16.2 (4.5) | 16.5 (4.8) |
| % Receiving oral steroids | 52 | 58 | 58 |
| DAS28 score (SD) | 6.79 (0.93) | 6.78 (0.97) | 6.80 (1.06) |
| Rheumatoid factor (%) | 79 | 73 | 75 |
| <LLN haemoglobin, n (%) | 60 (35.3) | 52 (32.3) | 57 (36.1) |
| Tender joint count (SD) | 31.7 (15.4) | 31.3 (15.1) | 30.4 (16.8) |
| Swollen joint count (SD) | 18.9 (10.9) | 19.5 (10.4) | 18.9 (11.1) |
| Erythrocyte sedimentation rate, mm/h (SD) | 49.1 (27.9) | 51.3 (28.3) | 54.6 (32.7) |
| C-reactive protein, mg/dl (SD) | 2.80 (3.37) | 3.11 (3.61) | 3.71 (4.12) |
| HAQ–DI (SD) | 1.7 (0.6) | 1.7 (0.6) | 1.7 (0.6) |
| Pain VAS, 100 mm (SD) | 64.7 (20.6) | 63.5 (22.2) | 64.1 (21.8) |
| Patient VAS, 100 mm (SD) | 70.2 (20.0) | 70.4 (23.8) | 70.9 (21.1) |
| Physician VAS, 100 mm (SD) | 66.4 (18.0) | 66.5 (16.1) | 67.5 (16.1) |
DAS28, disease activity score based on 28 joints; DMARD, disease-modifying anti-rheumatic drug; HAQ–DI, Health Assessment Questionnaire disease index; LLN, lower limit of normal; TNF, tumour necrosis factor; VAS, visual analogue score.