Summary of secondary efficacy results‡
| Median (range) IL-6 (IU/l) | Mean (SD) pain VAS (mm) | Mean (SD) DAS 28 | ||||
|---|---|---|---|---|---|---|
| Baseline | MR | IR | MR | IR | MR | IR |
| Start DB† (N=288) | 860 (200–23000) | 1110 (200–20800) | 51 (15) | 52 (17) | 5.8 (0.8) | 5.9 (0.9) |
| n=142 | n=142 | n=141 | n=143 | n=144 | n=142 | |
| MR/MR | IR/MR | MR/MR | IR/MR | MR/MR | IR/MR | |
|---|---|---|---|---|---|---|
| End OP (N=219) | 470* (200–18300) | 515* (200–8100) | 40* (26) | 39* (24) | 4.8* (1.3) | 4.9* (1.2) |
| n=103 | n=114 | n=98 | n=107 | n=103 | n=115 |
↵* As a non-parametric approach for the paired samples, Wilcoxon signed rank tests were applied to the absolute changes from baseline of the double-blind phase (p<0.05).
↵† These data are from the double-blind phase.
↵‡ Descriptive p values are given for the absolute changes from the baseline double-blind phase for available pairs of data.
DAS 28, disease activity score of 28 joints; DB, double-blind study phase; IL-6, interleukin 6; IR, immediate-release; MR, modified-release; n, number of available data; N, number of patients enrolled; OP, open-label extension phase; VAS, visual analogue scale.