1. DAS28-CRP change from baseline over 24 weeks (TP1 per-protocol set) at baseline, the mean DAS28-CRP was 5.42 and 5.53 for GP2015 and ETN groups, respectively.
DAS28-CRP change from baseline over 24 weeks (TP1 per-protocol set) at baseline, the mean DAS28-CRP was 5.42 and 5.53 for GP2015 and ETN groups, respectively. The per-protocol set consists of all patients completing the study until week 24 without major protocol deviations. Error bars represent the SE. *Primary endpoint; †95% CI was contained within the prespecified equivalence margin of −0.6 to 0.6; a mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline using the TP1 per-protocol set. Equivalence was further confirmed with the analysis on the FAS (least squares mean difference: −0.06 (95% CI −0.25 to 0.12)). Per-protocol set: GP2015 (n=168), ETN (n=155). DAS28-CRP, disease activity score 28-joint count C reactive protein; ETN, reference etanercept; LS, least squares; TP1, treatment period 1.
Marco Matucci-Cerinic et al. RMD Open 2018;4:e000757
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