Primary outcome
DISEASE
In the PPS, patients in the TAS5315 combined group had an ACR20 response rate at week 12 (primary endpoint) of 78.9% (90% confidence interval (CI) 68.1% to 87.4%) compared with 60.0% (90% CI 43.4% to 75.0%) for patients in the placebo group (one-sided p=0.053; Proportion of patients achieving (A) 20% improvement in American College of Rheumatology (ACR) criteria (ACR20) at week 12 (primary endpoint), (B) ACR50 and (C) ACR70.Efficacy endpoints at 12 weeks in the per-protocol set*Fisher’s exact test versus placebo.†For comparison with TAS5315 4 mg and TAS5315 2 mg.‡For comparison with TAS5315 combined.§TAS5315 minus placebo.ACR20, 20% improvement in American College of Rheumatology criteria; CDAI, Clinical Disease Activity Index; DAS28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; hsCRP, high sensitivity C reactive protein; LS, least squares; SDAI, Simple Disease Activity Index.