Main instruments suggested for a general SLE trial, by end point
| End points* | Instruments |
| Primary | SRI-4 or BICLA |
| Secondary | SRI-4 or BICLA (based on the primary end point) |
| Exploratory | Change in active joint count (eg, JC-50) Change in CLASI-A (eg, CLASI-50) Change in glucocorticoid doses New flare (SELENA-SLEDAI Flare Index or BILAG-defined) and time to first flare Change in individual SRI-4 and BICLA components (eg, change in SLEDAI-2K) Time to SRI-4 or BICLA response SRI-5 to SRI-8 (and time to SRI-5 to SRI-8 response) LLDAS (and time to LLDAS) DORIS-remission (and time to remission) Change in C3 and anti-double-stranded DNA levels Change in proteinuria Change in relevant transcriptomic signature (eg, type I interferons) PROs: SF-36, FACIT-F, EQ-5D, Lupus QoL and/or LupusPRO |
*May vary with study design and statistical analysis plan (in particular the use of hierarchical secondary end points); exploratory outcomes in bold have been commonly used as secondary outcomes in previous SLE trials. In addition to efficacy end points, safety assessment is required throughout the trial.
BICLA, BILAG-based Combined Lupus Assessment; CLASI-A, Cutaneous Lupus Erythematosus Disease Area and Severity Index activity; DORIS, Definitions Of Remission In SLE; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue Scale; LLDAS, Lupus Low Disease Activity State; LupusPRO, Lupus Patient-Reported Outcome; PRO, patient-reported outcome; QoL, quality of life; SELENA-SLEDAI, Safety of Estrogens in SLE National Assessment-SLE Disease Activity Index; SF-36, Short Form 36; SLEDAI-2K, SLE Disease Activity Index 2000; SRI-4, SLE Responder Index-4.