| Characteristic | Group 1 | Group 2 | Golimumab + methotrexate | ||
| Group 3 | Group 4 | Groups 3 and 4 combined | |||
| Placebo + methotrexate | Golimumab 100 mg + placebo | 50 mg | 100 mg | ||
| Patients randomly assigned | 133 | 133 | 89 | 89 | 178 |
| Sex, n (%) women | 109 (82.0%) | 105 (78.9%) | 72 (80.9%) | 72 (80.9%) | 144 (80.9%) |
| Age, years | 52.0 (42.0 to 58.0) | 51.0 (42.0 to 59.0) | 52.0 (43.0 to 57.0) | 50.0 (45.0 to 56.0) | 51.0 (44.0 to 57.0) |
| Disease duration, years | 6.5 (3.1 to 11.9) | 5.9 (2.4 to 12.2) | 4.50 (2.1 to 9.7) | 6.70 (2.4 to 14.3) | 5.3 (2.1 to 12.3) |
| No of swollen joints, 0–66 | 12.0 (8.0 to 19.0) | 11.0 (8.0 to 17.0) | 13.0 (8.0 to 22.0) | 12.0 (8.0 to 18.0) | 12.5 (8.0 to 18.0) |
| No of tender joints, 0–68 | 21.0 (14.0 to 34.0) | 22.0 (14.0 to 32.0) | 26.0 (16.0 to 39.0) | 23.0 (15.0 to 33.0) | 24.5 (15.0 to 37.0) |
| Anti-CCP antibodies | 107 (80.5%) | 106 (79.7%) | 72 (80.9%) | 68 (76.4%) | 140 (78.7%) |
| Rheumatoid factor | 108 (81.2%) | 111 (83.5%) | 77 (86.5%) | 75 (84.3%) | 152 (85.4%) |
| Patient assessment of pain, VAS, 0–10 cm | 5.70 (3.60 to 7.50) | 6.00 (4.50 to 7.40) | 6.10 (4.70 to 7.70) | 6.40 (4.60 to 8.00) | 6.35 (4.60 to 8.00) |
| Patient global assessment of disease activity, VAS, 0–10 cm | 5.30 (3.70 to 7.20) | 5.60 (3.60 to 7.40) | 6.00 (3.80 to 7.90) | 5.90 (4.10 to 7.70) | 5.95 (3.90 to 7.80) |
| Evaluator global assessment of disease activity, VAS, 0–10 cm | 5.65 (4.30 to 6.85) | 5.80 (4.40 to 6.80) | 6.10 (5.10 to 7.10) | 6.10 (4.30 to 7.00) | 6.10 (4.70 to 7.10) |
| HAQ-DI, 0–3 | 1.250 (0.750 to 1.750) | 1.375 (0.875 to 1.8750) | 1.375 (1.000 to 1.875) | 1.375 (0.875 to 1.875) | 1.375 (0.875 to 1.875) |
| CRP, mg/dl | 0.80 (0.30 to 2.00) | 0.90 (0.40 to 2.50) | 1.00 (0.40 to 2.80) | 0.90 (0.40 to 2.40) | 0.95 (0.40 to 2.40) |
| DAS28 using CRP | 4.860 (4.194 to 5.480) | 4.803 (4.151 to 5.558) | 5.100 (4.060 to 5.651) | 4.902 (4.320 to 5.521) | 4.931 (4.174 to 5.598) |
| DAS28 using ESR | 6.111 (5.260 to 6.574) | 6.013 (5.198 to 6.800) | 6.105 (5.366 to 6.940) | 5.905 (5.292 to 6.805) | 6.008 (5.330 to 6.843) |
| Methotrexate dose, mg/week | 15.0 (15.0 to 20.0) | 15.0 (15.0 to 20.0) | 15.0 (15.0 to 20.0) | 15.0 (15.0 to 20.0) | 15.0 (15.0 to 20.0) |
| Duration of previous methotrexate use, years | |||||
| <1 | 33 (24.8%) | 30 (22.6%) | 20 (22.5%) | 17 (19.1%) | 37 (20.8%) |
| ⩾1 to <3 | 30 (22.6%) | 41 (30.8%) | 32 (36.0%) | 31 (34.8%) | 63 (35.4%) |
| ⩾3 | 68 (51.1%) | 62 (46.6%) | 37 (41.6%) | 40 (44.9%) | 77 (43.3%) |
| Patients taking corticosteroids | 87 (65.4%) | 90 (67.7%) | 67 (75.3%) | 62 (69.7%) | 129 (72.5%) |
| Prednisone or equivalent dose, mg/day | 7.3 (5.0 to 10.0) | 7.5 (5.0 to 10.0) | 7.5 (5.0 to 10.0) | 7.5 (5.0 to 10.0) | 7.5 (5.0 to 10.0) |
| Patients with previous use of DMARD other than methotrexate | 94 (70.7%) | 101 (75.9%) | 70 (78.7%) | 67 (75.3%) | 137 (77.0%) |
| Patients who required treatment for latent tuberculosis at baseline* | 31 (23.3%) | 26 (19.5%) | 18 (20.2%) | 17 (19.1%) | 35 (19.7%) |
Values are n (%) or median (interquartile range). CCP, cyclic citrullinated peptide; CRP, C-reactive protein; DAS28, disease activity score in 28 joints; ESR, erythrocyte sedimentation rate; DMARD, disease-modifying antirheumatic drug; HAQ-DI, health assessment questionnaire disability index; VAS, visual analogue scale. *Treatment usually consisted of isoniazid.