Table 1.
Patient characteristics at baseline (Period 1) and randomization (Period 2)
| Parameter | Period 1 | Period 2 | ||
|---|---|---|---|---|
| Baseline (N = 53) | ETN (N = 22) | PBO (N = 29) | Total (N = 51) | |
| Age, mean (SD), years | 40.6 (10.7) | 36.0 (10.6) | 43.6 (9.8) | 40.3 (10.8) |
| Female, n (%) | 41 (77.4) | 18 (81.8) | 22 (75.9) | 40 (78.4) |
| Race, n (%) | ||||
| White | 40 (75.5) | 17 (77.3) | 23 (79.3) | 40 (78.4) |
| Other | 13 (24.5) | 5 (22.7) | 6 (20.7) | 11 (21.6) |
| Symptom duration, mean (SD), years | 8.7 (5.5) | 8.4 (5.9) | 8.9 (5.5) | 8.7 (5.6) |
| Rheumatoid factor positive, n (%) | 42 (79.2) | 19 (86.4) | 22 (75.9) | 41 (80.4) |
| CCP3 antibody positive, n (%) | 51 (96.2) | 14 (63.6) | 22 (75.9) | 36 (70.6) |
| Prior corticosteroids, n (%) | 39 (73.6) | 17 (77.3) | 20 (69.0) | 37 (72.5) |
| Prior DMARDs, n (%) | 39 (73.6) | 19 (86.4) | 20 (69.0) | 39 (76.5) |
| Prior MTX, n (%) | 53 (100) | 22 (100) | 29 (100) | 51 (100) |
| Prior NSAIDs, n (%) | 26 (49.1) | 11 (50.0) | 14 (48.3) | 25 (49.0) |
| ESR, mean (SD), mm/h | 33.8 (21.2) | 14.5 (12.0)a | 15.1 (10.7)a | |
| CRP, mean (SD), mg/mL | 29.3 (45.2) | 12.1 (14.1)a | 9.2 (11.6)a | |
| DAS28-ESR, mean (SD) | 5.9 (1.0) | 2.5 (0.5)a | 2.5 (0.4)a | |
| DAS28-CRP, mean (SD) | 5.5 (1.0) | 2.5 (0.7)a | 2.4 (0.6)a | |
| CDAI, mean (SD) | 35.3 (11.2) | 5.1 (3.7)a | 5.1 (3.2)a | |
| SDAI, mean (SD) | 38.3 (12.3) | 6.3 (4.1)a | 6.0 (3.6)a | |
| 28SJC score, mean (SD) | 9.4 (4.8) | 1.1 (2.3)a | 0.7 (1.4)a | |
| 28TJC score, mean (SD) | 12.6 (6.4) | 1.3 (1.4)a | 1.1 (1.0)a | |
| HAQ-DI, mean (SD) | 1.5 (0.7) | 0.3 (0.3)a | 0.4 (0.5)a | |
| PGA, mean (SD) | 6.7 (1.6) | 1.4 (0.8)a | 1.7 (1.3)a | |
| PtGA, mean (SD) | 6.6 (1.8) | 1.4 (0.9)a | 1.6 (1.2)a | |
| Patient general health VAS, mean (SD) | 58.4 (22.7) | 11.0 (5.6)a | 13.2 (8.8)a | |
| Patient pain assessment VAS, mean (SD) | 64.7 (19.9) | 9.9 (5.6)a | 12.1 (8.7)a | |
CCP3 Cyclic citrullinated peptide, CDAI clinical disease activity index, CRP C-reactive protein, DAS28 Disease Activity Score in 28 joints, DMARD disease-modifying anti-rheumatic drug, ESR erythrocyte sedimentation rate, ETN etanercept, HAQ-DI health assessment questionnaire-disability index, MTX methotrexate, NSAID non-steroidal, anti-inflammatory drug, PBO placebo, PGA physician global assessment, PtGA patient global assessment, SD standard deviation, SDAI Simplified Disease Activity Index, 28SJC swollen joint count based on 28 joints, TJC tender joint count based on 28 joints, VAS visual analogue scale
aData at week 24 prior to entry into Period 2