Study DMP 777-006 is a preliminary clinical study in patients with an established diagnosis of SLE designed to evaluate the potential efficacy of DMP 777-mediated HNE inhibition in ameliorating either joint and/or skin manifestations of this systemic disease. The primary objectives will be to assess study related changes in patient perception of overall total body joint pain (Appendix H) and changes in tender-joint count (Appendix M). Secondary objectives will include the assessment of any study related changes in the following additional disease specific manifestations including: joint tenderness, soft tissue swelling, and warmth (referenced to a maximum of five index joints, overall disease activity as assessed by patient global self-assessment (Appendix I) and physician global patient-assessment (Appendex J), clinically suspect leukocytoclastic skin lesions (if present at the time of qualification) as assessed by visual appearance and overall total body skin lesion score (Appendix K), SLE disease Activity Index (SLEDAI) (Appendex L). Additional objectives will include: evaluation of blood-derived systemic inflammatory response variables, correlation of these parameters with any changes in clinical outcome measures, expansion of the clinical and laboratory AEs data base.
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