Demographic and baseline characteristics
| Characteristic | Placebo (single and multiple dose cohorts) (N=20) | PF-00547,659 (all active treatment groups) (N=60) |
| Gender | ||
| Male | 17 (85%) | 52 (87%) |
| Race | ||
| White | 20 (100%) | 58 (97%) |
| Asian | 0 | 1 (2%) |
| Hispanic | 0 | 1 (2%) |
| Age (years), mean (SD) | 47.9 (14.8) | 45.1 (13.1) |
| Weight (kg), mean (SD) | 83.7 (13.1) | 80.2 (14.7) |
| Disease duration (years), median (range) | 6.5 (0.3–23.5) | 6.2 (0.6–41.4) |
| Prior drug treatment for ulcerative colitis | ||
| Mesalazine | 17 (85%) | 47 (78%) |
| Azathioprine | 6 (30%) | 22 (37%) |
| Infliximab | 4 (20%) | 4 (7%) |
| Concomitant drug treatment for ulcerative colitis during the study | ||
| Mesalazine/prodrugs* | 18 (90%) | 50 (83%) |
| Azathioprine | 4 (20%) | 19 (32%) |
| Mercaptopurine | 1 (5%) | 1 (2%) |
| Steroids† | 8 (40%) | 30 (50%) |
| Baseline total Mayo score, median (IQR) | 7.5 (7.0–8.5) | 8.5 (7.0–9.5) |
| Baseline faecal calprotectin (mg/kg), geometric mean (95% CI) | N=20 | N=57 |
| 733 (340 to 1578) | 629 (425 to 932) | |
| Baseline hsCRP (mg/dl), mean (SD) | N=19 | N=58 |
| 10.3 (11.2) | 10.8 (21.4) | |
When the study commenced all women of childbearing potential were excluded; this criterion was subsequently relaxed to increase enrolment of younger women and make the study population more representative of patients with ulcerative colitis seen in the clinic, providing women of childbearing potential used at least two contraceptive methods.
↵* Predominantly mesalazine; also includes sulfasalazine, olsalazine.
↵† Includes prednisolone, methylprednisolone, prednisone, beclometasone, betamethasone, cortisone acetate, hydrocortisone.
hsCRP, high-sensitivity C reactive protein; IQR, interquartile range.