Patient demographics and disease characteristics of the rerandomised population at baseline (A and B) and rerandomisation (C)
| Variable | INF/SB2 (n=94) | INF/INF (n=101) | SB2/SB2 (n=201) |
| A. Demographics at baseline (week 0) | |||
| Age, years | 53.0±11.0 | 51.5±11.2 | 51.8±12.1 |
| Female, n (%) | 77 (81.9) | 79 (78.2) | 158 (78.6) |
| Race white, n (%) | 87 (92.6) | 88 (87.1) | 183 (91.0) |
| Height, cm | 165.7±8.0 | 165.4±7.5 | 165.2±9.0 |
| Weight, kg | 72.2±14.9 | 73.1±17.4 | 72.7±14.7 |
| BMI, kg/m2 | 26.3±5.1 | 26.8±6.4 | 26.6±5.0 |
| Disease duration, years | 6.3±5.4 | 6.7±6.1 | 6.3±6.2 |
| Rheumatoid factor positive, n (%) | 67 (71.3) | 66 (65.3) | 140 (69.7) |
| B. Disease characteristics at baseline (week 0) | |||
| Tender joint count (0–68) | 23.7±11.3 | 24.6±11.6 | 23.9±12.2 |
| Swollen joint count (0–66) | 14.6±7.6 | 14.3±7.2 | 14.1±6.8 |
| Duration of MTX use, months | 49.7±45.4 | 52.1±50.6 | 51.1±46.8 |
| MTX dose at baseline, mg/week | 14.3±3.9 | 15.2±4.0 | 14.7±4.1 |
| C reactive protein, mg/L | 13.8±21.9 | 13.7±18.8 | 12.0±19.1 |
| ESR, mm/hour | 45.7±23.0 | 45.3±19.7 | 43.0±17.5 |
| HAQ-DI (0–3) | 1.5±0.6 | 1.5±0.5 | 1.5±0.6 |
| Patient pain VAS (0–100), mm | 60.9±20.4 | 66.7±19.0 | 60.0±17.9 |
| Patient VAS (0–100), mm | 62.8±18.1 | 64.3±17.4 | 61.7±17.3 |
| Physician VAS (0–100), mm | 61.9±16.2 | 62.0±14.5 | 60.8±15.1 |
| DAS28 (ESR) | 6.5±0.7 | 6.6±0.8 | 6.4±0.8 |
| SDAI | 40.2±11.6 | 40.2±11.0 | 38.9±11.0 |
| CDAI | 38.8±11.3 | 38.9±10.6 | 37.7±10.7 |
| C. Disease characteristics at rerandomisation (week 54) | |||
| Tender joint count (0–68) | 6.2±7.0 | 8.2±10.5 | 7.3±9.2 |
| Swollen joint count (0–66) | 2.7±4.4 | 4.0±6.1 | 3.4±5.2 |
| C reactive protein, mg/L | 6.6±12.4 | 8.2±12.7 | 8.4±12.6 |
| ESR, mm/hour | 27.7±21.9 | 28.3±19.6 | 28.3±20.0 |
| HAQ-DI (0–3) | 1.0±0.6 | 1.0±0.6 | 1.0±0.7 |
| Patient pain VAS (0–100), mm | 35.9±23.4 | 35.8±22.7 | 35.6±23.8 |
| Patient VAS (0–100), mm | 35.5±22.6 | 35.8±21.9 | 34.8±23.3 |
| Physician VAS (0–100), mm | 24.5±18.1 | 25.0±17.1 | 25.1±18.0 |
| DAS28 (ESR) | 3.9±1.3 | 4.1±1.5 | 4.0±1.4 |
| SDAI | 13.2±10.0 | 15.2±12.0 | 14.6±12.2 |
| CDAI | 12.5±9.8 | 14.3±11.7 | 13.8±11.8 |
| Infliximab dose, mg/kg | 3.78±1.16 | 3.91±1.38 | 3.85±1.25 |
Values represent mean±SD or number (percentage) of patients.
BMI, body mass index; CDAI, Clinical Disease Activity Index; DAS28, disease activity score based on a 28-joint count; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire of Disability Index; INF, reference infliximab; MTX, methotrexate; SDAI, simplified disease activity index; VAS, visual analogue scale.