Table 1.
Crohn’s disease | Ulcerative colitis | |
---|---|---|
[n = 124] | [n = 71] | |
Trial design, n [%] | ||
Induction | 70 [56.5] | 50 [70.4] |
Maintenance | 22 [17.7] | 4 [5.6] |
Integrated induction/maintenance | 32 [25.8] | 17 [23.9] |
Trial phase, n [%] | ||
Phase I | 5 [4.0] | 5 [7.0] |
Phase II | 57 [46.0] | 32 [45.1] |
Phase III | 62 [50.0] | 34 [47.9] |
Trial setting, n [%] | ||
Single centre | 9 [7.3] | 5 [7.0] |
Multicentre, single nation | 29 [23.4] | 16 [22.5] |
Multicentre, multinational | 86 [69.4] | 50 [70.4] |
Active comparator, n [%] | ||
Aminosalicylate | 10 [8.1] | 15 [21.1] |
Corticosteroid | 8 [6.5] | 6 [8.5] |
Immunosuppressant | 11 [8.9] | 2 [2.8] |
Biologic | 57 [46.0] | 28 [39.4] |
Oral small molecule | 13 [10.5] | 7 [9.9] |
Other | 25 [20.2] | 13 [18.3] |
Total patients, n | ||
Total patients randomized | 26 042 | 16 798 |
Patients randomized to active treatment | 15 680 | 10 934 |
Patients randomized to placebo | 8987 | 5563 |
Median follow-up duration [wk, range] | 17 [2–112] | 10 [4–96] |
SD standard deviation