Demographics and baseline characteristics (FAS population)
| Parameter | CZP+MTX n=159 | PBO+MTX n=157 |
|---|---|---|
| Age (years) | 49.4±10.6 | 49.0±10.3 |
| Female, n (%) | 129 (81.1) | 127 (80.9) |
| Weight (kg) | 57.4±11.3 | 57.4±10.6 |
| BMI (kg/m2) | 22.4±3.9 | 22.5±3.7 |
| RA duration (months)* | 4.0±2.9 | 4.3±2.8 |
| <3 months, n (%) | 60 (37.7) | 57 (36.3) |
| 3–<6 months, n (%) | 60 (37.7) | 56 (35.7) |
| 6–12 months, n (%) | 39 (24.5) | 44 (28.0) |
| Previous DMARDs use, n (%) | 31 (19.5) | 29 (18.5) |
| Steroid use at baseline, n (%) | 26 (16.4) | 31 (19.7) |
| Anti-CCP antibody positive, n (%) | 159 (100.0) | 157 (100.0) |
| High titre (≥3 times of ULN), n (%) | 159 (100.0) | 157 (100.0) |
| Titre (U/mL)† | 176.7±107.5 | 185.2±107.7 |
| RF positive, n (%) | 153 (96.2) | 146 (93.0) |
| High titre (≥3 times of ULN), n (%) | 119 (74.8) | 117 (74.5) |
| Titre (U/mL)† | 182.5±177.4 | 167.3±166.5 |
| Bone erosion (judged by physician), n (%) | 79 (49.7) | 80 (51.0) |
| TJC (/28 joints) | 8.4±6.1 | 8.9±6.5 |
| SJC (/28 joints) | 8.3±5.3 | 8.4±5.3 |
| PtGADA (mm) | 50.4±22.4 | 52.9±22.7 |
| PhGADA (mm) | 56.7±20.5 | 58.4±21.4 |
| ESR (mm/h) | 38.4±25.3 | 43.7±28.2 |
| CRP (mg/dL) | 1.3±1.8 | 1.5±1.9 |
| MMP-3 (ng/mL)‡ | 130.4±135.4 | 185.4±214.9 |
| DAS28 (ESR) | 5.4±1.1 | 5.5±1.2 |
| SDAI | 28.7±12.5 | 30.0±13.6 |
| HAQ-DI score | 1.0±0.6 | 1.1±0.7 |
| mTSS | 5.2±8.8 | 6.0±15.3 |
| Negative (≤0.5), n (%) | 56 (35.2) | 56 (35.7) |
| Erosion score | 2.2±4.4 | 2.8±7.9 |
| Negative (≤0.5), n (%) | 82 (51.6) | 80 (51.0) |
| Joint space narrowing score | 2.9±5.8 | 3.2±8.6 |
| Negative (≤0.5), n (%) | 87 (54.7) | 82 (52.2) |
| Average weekly MTX dose (mg/week) | 11.6 (3.0) | 11.6 (2.7) |
Values are mean±SD unless otherwise indicated.
*Time from onset of persistent arthritic symptoms.
†Data exceeding measurement upper limit (≥300 U/mL) are regarded as 300 U/mL.
‡Normal range: 36.9–121 (male), 17.3–59.7 (female) ng/mL.
BMI, body mass index; CCP, cyclic citrullinated peptide; CRP, C reactive protein; CZP, certolizumab pegol; DAS28 (ESR), Disease Activity Score 28-joint assessment; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire Disability Index; MMP-3, matrix metalloproteinase-3; mTSS, modified Total Sharp Score; MTX, methotrexate; PBO, placebo; PhGADA, physician global assessment of disease activity; PtGADA, patient's global assessment of disease activity; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, Simple Disease Activity Index; SJC, swollen joint count; TJC, tender joint count; ULN, upper limit of normal.