| Methotrexate plus placebo | Methotrexate plus infliximab | Total | ||
| 3 mg/kg | 6 mg/kg | |||
| Patients randomly assigned | 298 | 373 | 378 | 1049 |
| Sex, N (%) | ||||
| Male | 75 (25.2%) | 106 (28.4%) | 122 (32.3%) | 303 (28.9%) |
| Female | 223 (74.8%) | 267 (71.6%) | 256 (67.7%) | 746 (71.1%) |
| Age, years | ||||
| Mean (SD) | 50 (13) | 51 (12) | 49 (13) | 50 (13) |
| Disease activity scores, mean (SD) | ||||
| DAS28-ESR | 6.69 (1.04) | 6.62 (1.07) | 6.72 (1.01) | 6.67 (1.04) |
| CDAI | 45.1 (11.8) | 43.7 (12.0) | 45.24 (12.8) | 44.6 (12.2) |
| SDAI | 47.6 (13.1) | 46.6 (13.2) | 48.18 (13.8) | 47.5 (13.4) |
CDAI, clinical disease activity index; DAS28-ESR, disease activity score, employing the 28-joint count and erythrocyte sedimentation rate; SDAI, simplified disease activity index.