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Rheumatology 2008 47(Supplement 5):v31-v32; doi:10.1093/rheumatology/ken266
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© The Author 2008. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

This article appears in the following Rheumatology issue: Update in systemic sclerosis [View the issue table of contents]

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

D. Khanna1

1Division of Rheumatology, Department of Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.

Correspondence to: D. Khanna, Division of Rheumatology, Department of Medicine, David Geffen School of Medicine, 1000 Veteran Avenue, Rm 32-59 Rehabilitation Building, Los Angeles, CA 90095, USA. E-mail: dkhanna{at}mednet.ucla.edu


  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.

KEY WORDS: Provisional core set, Systemic sclerosis, Scleroderma, Response measure, Clinical trials, Combined Response Index

Submitted 30 April 2008; Accepted 18 June 2008


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