Table 5. Change from Baseline to Week 12 in CDAI, CRP, and CDEIS.
| Placebo(N = 144) | 250 mg q.d. CCX282-B(N = 98) | 250 mg b.i.d. CCX282-B(N = 96) | 500 mg q.d. CCX282-B(N = 97) | |
| Crohn’s Disease Activity Index | ||||
| Baseline | ||||
| Mean (SD) | 329.9 (49.47) | 340.1 (54.29) | 332.3 (52.36) | 332.5 (55.68) |
| Median | 321.0 | 333.5 | 326.5 | 335.0 |
| Min, Max | 250, 454 | 249, 449 | 249, 471 | 249, 446 |
| n | 144 | 98 | 96 | 97 |
| Week 12–Change from baseline | ||||
| Mean (SD) | −115.9 (116.07) | −134.2 (99.87) | −121.7 (101.21) | −136.0 (102.05) |
| Median | −126.9 | −147.1 | −125.3 | −146.2 |
| Min, Max | −368, 251 | −345, 88 | −375, 105 | −338, 109 |
| n | 120 | 85 | 85 | 87 |
| C-reactive protein, mg/L | ||||
| Baseline | ||||
| Mean (SD) | 30.8 (27.87) | 28.0 (22.62) | 27.6 (22.63) | 30.3 (27.13) |
| Median | 21.6 | 22.3 | 21.8 | 21.4 |
| Min, Max | 4.4, 200.0 | 2.7, 124.0 | 4.3, 165.5 | 6.6, 182.0 |
| n | 144 | 98 | 96 | 97 |
| Week 12–Change from baseline | ||||
| Mean (SD) | −4.4 (34.08) | −4.1 (26.50) | −1.4 (31.06) | −6.6 (34.84) |
| Median | −2.9 | −3.1 | −4.5 | −6.7 |
| Min, Max | −199.6, 115.2 | −123.7, 72.1 | −82.6, 133.6 | −175.4, 117.0 |
| N | 138 | 97 | 96 | 94 |
| Crohn’s Disease Endoscopic Index of Severity (CDEIS) a | ||||
| Baseline | ||||
| Mean (SD) | 19.1 (15.02) | 23.5 (20.56) | 18.7 (14.14) | 29.5 (23.28) |
| Median | 14.0 | 16.2 | 16.5 | 23.0 |
| Min, Max | 2, 58 | 1, 65 | 1, 48 | 2, 78 |
| n | 48 | 24 | 26 | 22 |
| Week 12–Change from baseline | ||||
| Mean (SD) | −3.0 (11.44) | −8.7 (11.60) | 2.0 (10.75) | −10.8 (17.70)* |
| Median | −0.5 | −5.2 | −1.8 | −7.2 |
| Min, Max | −28, 30 | −30, 6 | −12, 35 | −51, 17 |
| n | 37 | 16 | 21 | 16 |
a
CDEIS calculated using a modification of the method described by Mary and Modigliani13. The length of disease involvement and ulceration was recorded as actual lengths, in cm, rather than normalized on a 10-cm scale.
*
p = 0.049; p-value based on a repeated measures mixed effect ANOVA model, including terms for treatment, time point, treatment by time point interaction, and geographic region.