Baseline demographics and disease activity for the phase IIb CREATE study
| Baseline or demographic characteristic | AZD9056 50 mg (n=63) | AZD9056 100 mg (n=64) | AZD9056 200 mg (n=63) | AZD9056 400 mg (n=64) | Placebo (n=65) | Open-label etanercept (n=64) |
|---|---|---|---|---|---|---|
| Age (years) | 51.8±12.82 | 53.5±11.45 | 50.1±11.91 | 52.3±11.80 | 51.5±11.93 | 51.2±10.76 |
| Female, n (%) | 56 (88.9) | 54 (84.4) | 51 (81.0) | 59 (92.2) | 54 (83.1) | 55 (85.9) |
| Duration of RA (years) | 8.0±7.18 | 8.4±6.55 | 6.9±7.28 | 7.6±7.64 | 8.2±7.59 | 7.9±7.15 |
| Baseline rheumatoid factor positivity, n (%) | 49 (77.8) | 54 (84.4) | 52 (82.5) | 47 (73.4) | 53 (81.5) | 55 (85.9) |
| Baseline anti-CCP positivity, n (%) | 53 (84.1) | 48 (75.0) | 52 (82.5) | 50 (78.1) | 52 (80.0) | 56 (87.5) |
| Tender joint count | 14.8±6.37 | 13.9±6.11 | 15.1±6.77 | 14.5±5.81 | 13.5±5.95 | 14.8±6.57 |
| Swollen joint count | 10.1±4.37 | 11.0±5.49 | 11.6±5.08 | 9.6±4.25 | 10.3±4.31 | 11.2±6.61 |
| HAQ-DI | 1.3±0.76 | 1.4±0.66 | 1.6±0.56 | 1.4±0.57 | 1.4±0.59 | 1.5±0.68 |
| DAS28 | 6.3±0.82 | 6.4±0.95 | 6.4±0.78 | 6.2±0.78 | 6.3±0.76 | 6.4±0.85 |
| CRP, median* (range) | 10.3 (0, 119) | 10.7 (1, 107) | 8.2 (0, 86) | 7.8 (1, 116) | 9.6 (0, 79) | 10.0 (1, 70) |
| ESR, median* (range) | 36.0 (16, 140) | 42.0 (2, 100) | 37.0 (10, 90) | 36.5 (11, 117) | 38.0 (9, 110) | 40.0 (15, 100) |
| Baseline mTSS per year duration of RA, median (quartiles) | 8.3 (1.1, 114.7) | 7.9 (0.4, 56.3) | 9.8 (0.7, 138.8) | 12.5 (0.3, 62.8) | 9.7 (0.8, 97.8) | 8.0 (0.3, 78.5) |
| Baseline mTSS, median (quartiles) | 44 (2, 214) | 45 (3, 213) | 48 (2, 214.5) | 51.2 (2, 301.5) | 61 (2, 227) | 49.8 (4, 194.5) |
Values are mean±SD unless stated otherwise.
* Entry criteria required either ESR ≥28 mm/h or CRP ≥10 mg/l
CCP, serum anti-cyclic citrullinated peptide; CRP, C-reactive protein; DAS28, Disease Activity Score (based on 28 joint counts); ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; mTSS, modified total Sharp score; RA, rheumatoid arthritis.