Table 1

Summary of Efficacy Results (Efficacy Analysis Population)

RG6125 810 mg (N=72)Placebo(N=37)Difference -(90% CI)
ACR50 Responders - n(%) 8 (11.1%)6 (16.2%)-5.1%(-19.8%, 6.9%)
ACR20 Responders - n(%) 20 (27.8%)16 (43.2%)-15.5%(-32.4%, 1.6%)
ACR70 Responders - n(%) 1 (1.4%)0 (0.0%)1.4%(-7.9%, 7.0%)
Change from Baseline in DAS28 – adjusted mean* -1.18(n=65)-1.65(n=36)0.48(-0.84, -0.12)
Change from Baseline in CDAI – adjusted mean* -14.67(n=65)-17.94(n=36)3.27(-7.47, 0.94)
Change from Baseline in SDAI – mean (SD) -20.69 (35.29)(n=63)-21.31 (33.82)(n=33)-
Change from Baseline in HAQ-DI – mean (SD) -0.24 (0.51)(n=65)-0.15 (0.52)(n=37)-
RAMRIS Synovitis Score – median (range) 0.00 (-6.3 – 4.5)(n=59)-0.25 (-4.0 – 2.7)(n=27)-
RAMRIS Osteitis Score – median (range) 0.00 (-15.3 – 8.0)(n=59)0.00 (-13.0 – 1.3)(n=27)-
RAMRIS Bone Erosion Score – median (range) 0.00 (-6.0 – 3.5)(n=59)0.00 (-1.0 – 2.5)(n=27)-