Table 1.

Selected efficacy endpoints at Week 12

EfficacyPBO1 mg QD2 mg QD4 mg QD8 mg QD
(N=49)(N=24)(N=24)(N=24)(N=24)
% ACR20*3167 83 67 88
% ACR50*833 46 50 54
% DAS28-CRP <2.62229333838
% DAS28-CRP <3.2 315063 67 79
% SDAI ≤3.3 8429 1717
% HAQ-DI ≤0.5 4550546383
% Pts achieving improvement from baseline of ≥0.22 (MCID)2954 58 75 71
  • 1-sided Fisher's exact test.

  • * Non-responder imputation;

  • last observation;

  • p<0.05 vs. PBO.