Primary Endpoint1
- ACR50 response at Week 12
Ranked Secondary Endpoints3,8
At Week 12:
- Change from baseline in DAS28-CRP
- Change from baseline in HAQ-DI
- Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
- Change from baseline in SF-36 (PCS)
At Week 24:
- Change from baseline in mTSS
- Proportion of patients achieving DAS28-CRP<2.6 (CR)
Select prespecified
nonranked endpoints2,3,9,10
- ACR 20/50/70 at all visits (except those that were ranked timepoints)
- Change from baseline in mTSS at Week 24, Week 48, and Week 96
- Proportion of patients with no radiographic progression (mTSS ≤0) at Week 24, Week 48, and Week 96
- Change from baseline in JE and JSN score at Week 24, Week 48, and Week 96
Data Limitations
Prespecified nonranked endpoints were not controlled for multiplicity; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made.