Secondary Efficacy Measures/Variables and Endpoints Sample Clauses

Secondary Efficacy Measures/Variables and Endpoints. The secondary efficacy variables and endpoints for this study are as follows: • proportion of patients achieving an SRI response at each visit during the treatment period • proportion of patients achieving a reduction of at least 4 points in the SLEDAI-2K total score at each visit during the treatment period • proportion of patients achieving a clinical SLEDAI-2K response at each visit during the treatment period, where the clinical response is defined as a reduction of at least 4 points in the SLEDAI-2K clinical score • proportion of patients achieving a BILAG-2004 response at each visit during the treatment period (no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline) • proportion of patients achieving a BILAG-2004 clinical response at each visit during the treatment period (an improvement in at least 1 category from a B score to a C or D score, with no worsening in any other category) • proportion of patients showing no worsening on a PhGA scale at each visit during the treatment period • proportion of patients achieving a reduction of 5 points in the SLEDAI-2K total score at each visit during the treatment period • proportion of patients achieving a reduction of 6 points in the SLEDAI-2K total score at each visit during the treatment period • proportion of patients achieving an SRI-5 response at each visit during the treatment period • proportion of patients achieving an SRI-6 response at each visit during the treatment period • proportion of patients showing an improvement in tender and swollen joint counts using the 28-joint count examination for pain and tenderness at each visit during the treatment period • SFI at each visit during the treatment period — time to first mild to moderate flare — incidence of mild to moderate flare — time to severe flare (NOTE: A severe flare leads to early withdrawal) • changes in the SDI over time (assessed at screening and weeks 24 and 52 [or final assessment]) • absolute and relative changes in the SF-36 at weeks 12, 24, 36, and 52 (or final assessment) proportion of patients with changes in steroid dose over time throughout the study The exploratory efficacy variables and endpoints for this study are as follows: • changes in the biomarkers anti-dsDNA Ab, C3, and C4 at each visit during the treatment period • changes in the following biomarkers at weeks 4, 12, 24, 36, and 52 (or final assessment): — XXX — anti–U1-70K snRNP Ab — anti-Sm Ab — CRP — IgG, IgM, IgA and IgE • ab...
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