A standardized core set for systemic sclerosis clinical trials. First step in development of combined response index

Rheumatology (Oxford). 2008 Oct;47 Suppl 5(Suppl 5):v31-2. doi: 10.1093/rheumatology/ken266.

Abstract

SSc can be associated with a high morbidity and mortality. Due to the complexity and heterogeneity of the disease, a composite response measure that will capture differing organ involvements and patient-reported outcomes is desirable. Recently, with participation of the Scleroderma Clinical Trial Consortium, a standardized core set of items were proposed for SSc clinical trials using a structured Delphi exercise. The Delphi exercise identified 11 domains relevant to SSc clinical trials. Currently, efforts are under way to develop a combined response index for clinical trials in diffuse cutaneous SSc.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic*
  • Health Status Indicators
  • Humans
  • Reference Standards*
  • Research Design
  • Scleroderma, Systemic / drug therapy*
  • Treatment Outcome