Journal
RHEUMATOLOGY
Volume 47, Issue -, Pages V31-V32Publisher
OXFORD UNIV PRESS
DOI: 10.1093/rheumatology/ken266
Keywords
Provisional core set; Systemic sclerosis; Scleroderma; Response measure; Clinical trials; Combined Response Index
Categories
Funding
- NIAMS NIH HHS [U01 AR055057-01, K23 AR053858, K23 AR053858-01A1, U01 AR055057] Funding Source: Medline
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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.
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