Once-daily dosing | Twice-daily dosing | ||||||
---|---|---|---|---|---|---|---|
Placebo | 50mg | 100mg | 200mg | 25mg | 50mg | 100mg | |
n=86 | n=82 | n=85 | n=86 | n=86 | n=85 | n=84 | |
Week 12 | |||||||
ACR20, NRI1, % | 44 | 56 | 64* | 69** | 57 | 60 | 79*** |
ACR50, NRI, % | 15 | 33* | 38** | 43*** | 28* | 34* | 55*** |
ACR70, NRI, % | 8 | 16 | 21 | 24* | 14 | 19 | 31** |
DAS28(CRP), mean change from BL2, LOCF3 | −1.2 | −1.8** | −2.2*** | −2.5*** | −1.9** | −2.1*** | −2.8*** |
CDAI4, mean change from BL, LOCF | −17 | −20 | −24** | −26*** | −21* | −23** | −29*** |
Week 24 | |||||||
ACR20, NRI, % | 42 | 55 | 61* | 73*** | 56 | 60* | 80*** |
ACR50, NRI, % | 16 | 35** | 47*** | 50*** | 35** | 35** | 55*** |
ACR70, NRI, % | 9 | 22* | 33** | 29** | 21* | 24* | 39*** |
DAS28(CRP), mean change from BL, LOCF | −1.2 | −2.0*** | −2.7*** | −2.8*** | −2.2*** | −2.4*** | −3.2*** |
CDAI, mean change from BL, LOCF | −16 | −21** | −29*** | −29*** | −24*** | −27*** | −32*** |
*p<0.05 vs. placebo; **p<0.01 vs. placebo; ***p<0.001 vs. placebo; ACR scores based on ITT analysis. 1Non-responder imputation. 2Baseline. 3Last observation carried forward. 4Clinical Disease Activity Index.