PRIMARY ENDPOINT1
- ACR20 response: RINVOQ 15 mg + MTX vs Placebo + MTX at Week 12
SELECT RANKED SECONDARY ENDPOINTS2
At Week 12 vs Placebo + MTX:
- Change from baseline in DAS28-CRP
- Change from baseline in HAQ-DI
- Change from baseline in SF-36 (PCS)
- Proportion of patients achieving DAS28-CRP≤3.2 (LDA)
- Proportion of patients achieving DAS28-CRP<2.6 (CR)
At Week 12 vs Adalimumab + MTX:
- ACR50 response (superiority)
- Change from baseline in Patient's assessment of pain (superiority)
- Change from baseline in HAQ-DI (superiority)
At Week 26 vs Placebo + MTX:
- Change from baseline mTSS
SELECT PRESPECIFIED NONRANKED ENDPOINTS3,9,10
- ACR20/50/70 response rates and change from baseline in individual ACR components at all visits (except those that were ranked timepoints)
- Proportion of patients achieving CR based on DAS28-CRP, DAS28-ESR, SDAI, CDAI, and Boolean criteria at all visits (except those that were ranked timepoints)
- Proportion of patients with no radiographic progression (mTSS ≤0) at Week 26, Week 48, and Week 96
- Change from baseline in mTSS at Week 24, Week 48, and Week 96
- Change from baseline in joint space narrowing score and joint erosion score at Week 26, 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.
SELECT-COMPARE was not designed to evaluate the efficacy of HUMIRA + MTX vs Placebo + MTX. No conclusions regarding this comparison can be made.