Journal of Clinical & Experimental Dermatology Research
Open Access
ISSN: 2155-9554
+44 1478 350008
ISSN: 2155-9554
+44 1478 350008
Julie A. Brevard
Idera Pharmaceuticals, Inc.,
Cambridge, MA
Tanzania
Research
Design Considerations for Clinical Trials Using the Cutaneous Dermatomyositis Disease Area and Severity Index as a Primary Endpoint
Author(s): Julie A. Brevard, Mark Hurtt, Joanna Horobin, Olga Polyanskaya, James Baker, Victoria P. Werth and David F. FiorentinoJulie A. Brevard, Mark Hurtt, Joanna Horobin, Olga Polyanskaya, James Baker, Victoria P. Werth and David F. Fiorentino
Objective: Skin inflammation is a universal characteristic of the multisystem inflammatory myopathy dermatomyositis (DM). About 35% of DM patients have a polycyclic or chronic disease course, usually due to active skin disease, despite standard of care therapy, demonstrating a significant unmet need for novel treatment options. To test the efficacy of novel therapeutics, feasible prospective clinical trials must be designed that employ quantitative endpoints. The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a validated, reliable, and responsive measurement of cutaneous DM disease activity and damage. The primary objectives were to identify requisite design parameters (e.g., target trial population, duration, frequency of assessments, treatment difference, sample size) for a proofofconcept clinical trial of a novel therapy in patients with DM... View More»
DOI:
10.4172/2155-9554.1000401