| Characteristics | All patients (n = 854) | Patients with fistulas at baseline | ||
| Placebo (n = 47) | Adalimumab (n = 70) | All patients with fistulas (n = 117) | ||
| Male, no (%) | 326 (38.2) | 15 (31.9) | 34 (48.6) | 49 (41.9) |
| Age in years, mean (SD) | 37.1 (11.9) | 36.5 (10.1) | 35.9 (12.2) | 36.1 (11.4) |
| Baseline CDAI score, mean (SD) | 313.1 (62.0) | 308.0 (59.3) | 318.4 (55.8) | 314.3 (57.2) |
| CRP (mg/dl) | ||||
| Mean (SD) | 2.3 (3.4) | 3.6 (4.7) | 2.8 (3.0) | 3.1 (3.8) |
| Median (range) | 0.9 (0.02–35.0) | 2.3 (0.12–28.7) | 1.8 (0.06–12.3) | 1.9 (0.06–28.7) |
| CRP concentration ⩾1.0 mg/dl (10 mg/l), n (%) | 407 (47.7) | 32 (68.1) | 42 (60.0) | 74 (63.2) |
| Previous TNF antagonist exposure, n (%) | 424 (49.6) | 31 (66.0) | 41 (58.6) | 72 (61.5) |
| Concomitant medication, n (%) | ||||
| Any glucocorticoid* | 376 (44.0) | 20 (42.6) | 29 (41.4) | 49 (41.9) |
| Prednisone | 244 (28.6) | 14 (29.8) | 18 (25.7) | 32 (27.4) |
| Budesonide | 100 (11.7) | 9 (19.1) | 2 (2.9) | 11 (9.4) |
| Any immunosuppressive agent | 399 (46.7) | 26 (55.3) | 31 (44.3) | 57 (48.7) |
| Azathioprine | 275 (32.2) | 21 (44.7) | 24 (34.3) | 45 (38.5) |
| 6-Mercaptopurine | 81 (9.5) | 4 (8.5) | 3 (4.3) | 7 (6.0) |
| Methotrexate | 90 (10.5) | 3 (6.4) | 7 (10.0) | 10 (8.5) |
| 5-Aminosalicylates† | 334 (39.1) | 13 (27.7) | 24 (34.3) | 37 (31.6) |
| Current smoker, no (%) | 303 (35.5) | 18 (38.3) | 20 (28.6) | 38 (32.5) |
*Includes betamethasone, budesonide, dexamethasone, deflazacort, cortisone, cloprednol, fluocortolone, glucocorticoids, hydrocortisone, methylprednisolone, prednisolone, prednisone, paramethasone and prednylidene. †Aminosalicylic acid, balsalazide, mesalazine, olsalazine, sulfasalazine. CDAI, Crohn’s disease activity index; CRP, C-reactive protein; TNF, tumour necrosis factor.