| Characteristics | Placebo + MTX (n = 127) | Certolizumab pegol 200 mg + MTX (n = 246) | Certolizumab pegol 400 mg + MTX (n = 246) |
| Demographics | |||
| Age (years), mean (SD) | 51.5 (11.8) | 52.2 (11.1) | 51.9 (11.8) |
| Female, n (%) | 107 (84.3) | 206 (83.7) | 192 (78.0) |
| Disease duration (years), mean (SD) | 5.6 (3.9) | 6.1 (4.1) | 6.5 (4.3) |
| No of prior DMARDs (excluding MTX), mean (SD) | 1.2 (1.2) | 1.2 (1.3) | 1.3 (1.2) |
| MTX (mg/week), mean (SD) | 12.2 (3.3) | 12.5 (3.6) | 12.6 (3.7) |
| Steroid use, n (%) | 76 (59.8) | 136 (55.3) | 152 (61.8) |
| Previous anti-TNF use, n (%)* | 2 (1.6) | 4 (1.6) | 2 (0.8) |
| ACR core components | |||
| No of tender joints (0–68), mean (SD) | 30.4 (13.4) | 30.1 (14.5) | 30.0 (13.9) |
| No of swollen joints (0–66), mean (SD) | 21.9 (9.7) | 20.5 (9.6) | 21.0 (10.2) |
| Physician’s global assessment of arthritis (mm), mean (SD) | 65.7 (15.1) | 64.3 (14.6) | 62.8 (14.0) |
| Patient’s global assessment of arthritis (mm), mean (SD) | 59.9 (21.9) | 62.4 (20.4) | 61.1 (19.6) |
| Patient’s assessment of arthritic pain (mm), mean (SD) | 59.9 (22.2) | 61.8 (19.3) | 60.5 (20.0) |
| CRP (mg/l), geometric mean (CV)† | 13.5 (185.8) | 14.2 (190.8) | 13.1 (169.9) |
| ESR (mm/h), geometric mean (CV) | 40.8 (45.2) | 43.7 (41.4) | 39.1 (40.2) |
| HAQ-DI, mean (SD) | 1.6 (0.6) | 1.6 (0.6) | 1.6 (0.6) |
| Duration of morning stiffness (h), median (range) | 2.0 (0 to 24.0) | 2.0 (0 to 24.0) | 2.0 (0 to 24.0) |
| Rheumatoid factor | |||
| RF positive (⩾14 IU/ml), n (%) | 97 (78.2) | 186 (77.5) | 179 (75.5) |
| RF plasma concentration (IU/ml), mean (SD) | 135.4 (179.6) | 145.3 (232.7) | 149.4 (245.5) |
| x-Ray progression | |||
| Estimated yearly progression‡ (mTSS/year) | 8.7 | 6.6 | 7.4 |
| mTSS, mean (SD) | 46.5 (58.6) | 39.6 (50.1) | 46.7 (56.0) |
| ES, mean (SD) | 23.1 (32.1) | 19.0 (26.8) | 21.6 (29.7) |
| JSN, mean (SD) | 23.4 (27.7) | 20.6 (24.4) | 25.1 (28.1) |
| Disease activity (DAS28 (ESR)), mean (SD) | 6.83 (0.87) | 6.85 (0.84) | 6.80 (0.79) |
*Only 2 patients (both in the CZP 200 mg + MTX group) were previously treated with two or more anti-TNF agents; †normal 0–6 mg/l; ‡baseline mean mTSS divided by mean duration of rheumatoid arthritis.
ACR, American College of Rheumatology; CRP, C-reactive protein; CV, coefficient of variation; CZP, certolizumab pegol; DAS28(ESR), Disease Activity Score 28; DMARD, disease-modifying antirheumatic drug; ES, erosion score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intention-to-treat; JSN, joint space narrowing; mTSS, modified Total Sharp Scores; MTX, methotrexate; RF, rheumatoid factor; TNF, tumour necrosis factor.