Primary Efficacy Variable Sample Clauses

Primary Efficacy Variable. The primary efficacy variable for this study is the proportion of patients achieving a combined clinical response using the SRI at week 52. An SRI response is defined as a reduction from baseline in the SLEDAI-2K score of at least 4 points, no worsening in PhGA (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new BILAG A body system score, and no more than 1 new BILAG B body system score from baseline. The combined clinical response is intended to demonstrate an improvement in overall disease activity without worsening of disease in any organ system as determined by the investigator’s quantitative and qualitative assessments. The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105. A SLEDAI-2K score of 6 to 10 is indicative of moderate disease activity, and improvement is defined as a reduction of greater than 3 points (Appendix C). The SLEDAI-2K was chosen because it is an accepted scale for assessing disease activity, has been shown to be reliable and sensitive to change, and is easy for clinicians to use. The SLEDAI-2K should be administered at each visit throughout the study by the same physician assessor trained and qualified to use this scale. The PhGA will be completed by the physician using a 3-inch visual analog scale (VAS) labeled from 0=none to 3=severe (Appendix C). This scale was chosen because it measures a domain of disease activity that may not be fully assessed in the other measures of disease activity. A change of greater than 0.3 point on the VAS indicates worsening. The PhGA should be administered at each visit throughout the study by the same physician assessor trained and qualified to use this scale. The BILAG-2004 is a validated objective and subjective global measure of the disease activity of SLE based upon the physician intention to treat and refers to disease activity within the last month prior to completion of the index. It includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems; each organ system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=patient needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activi...