The goal of the efforts proposed in this grant application is to conduct a consensus meeting of an international group of clinician-scientists and clinical trials methodologists to produce standardized response criteria for systemic lupus erythematosus (SLE) trials in the """"""""units"""""""" of existing disease activity measures and by selected major organ systems. The field of experimental therapeutics in SLE is on a steep slope of discovery and their evaluation in human subjects will be enhanced if standard end points are used. Standard response criteria will allow meaningful comparisons between trials, promote the use of innovative study designs, and greatly improve the efficiency and shorten the time-line for testing new interventions. This grant will support a meeting of stakeholders to develop consensus response criteria based on data from an international pre-meeting exercise in which over 1000 patient histories were evaluated. Consensus building techniques, such as Delphi and nominal group techniques will be used.
| Liang, Matthew H; Simard, Julia F; Costenbader, Karen et al. (2009) Methodologic issues in the validation of putative biomarkers and surrogate endpoints in treatment evaluation for systemic lupus erythematosus. Endocr Metab Immune Disord Drug Targets 9:108-12 |
| Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria for Fatigue (2007) Measurement of fatigue in systemic lupus erythematosus: a systematic review. Arthritis Rheum 57:1348-57 |
| Ad Hoc Committee Response Criteria For Cutaneous SLE (2007) Response criteria for cutaneous SLE in clinical trials. Clin Exp Rheumatol 25:666-71 |
| Ad Hoc Committee on Lupus Response Criteria: Cognition Sub-committee; Mikdashi, Jamal A; Esdaile, J M et al. (2007) Proposed response criteria for neurocognitive impairment in systemic lupus erythematosus clinical trials. Lupus 16:418-25 |
| Renal Disease Subcommittee of the American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria (2006) The American College of Rheumatology response criteria for proliferative and membranous renal disease in systemic lupus erythematosus clinical trials. Arthritis Rheum 54:421-32 |
| American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria (2004) The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: measures of overall disease activity. Arthritis Rheum 50:3418-26 |
| Ad Hoc Working Group on Steroid-Sparing Criteria in Lupus (2004) Criteria for steroid-sparing ability of interventions in systemic lupus erythematosus: report of a consensus meeting. Arthritis Rheum 50:3427-31 |
