Open AccessA randomised, double-blind, placebo-controlled phase 3 study of lenabasum in diffuse cutaneous systemic sclerosis: RESOLVE-1 design and rationale
Author(s) -
Robert Spiera,
Dinesh Khanna,
Masataka Kuwana,
Daniel E. Fürst,
Tracy Frech,
Laura K. Hummers,
Wendy Stevens,
Marco MatucciCerinic,
Murray Baron,
Oliver Distler,
Nancy Dgetluck,
Bradley J. Bloom,
Quinn Dinh,
Barbara White,
Christopher P. Denton
Publication year - 2021
Publication title -
clinical and experimental rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.184
H-Index - 95
eISSN - 1593-098X
pISSN - 0392-856X
DOI - 10.55563/clinexprheumatol/i80zh7
Subject(s) - medicine , placebo , clinical trial , rheumatology , clinical endpoint , physical therapy , systemic therapy , surgery , pathology , alternative medicine , cancer , breast cancer
The multi-systemic, heterogenous nature of diffuse cutaneous systemic sclerosis (dcSSc) presents challenges in designing clinical studies that can demonstrate a treatment effect on overall disease burden. We describe the design of the first Phase 3 study in dcSSc patients where the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score was chosen prospectively as the primary outcome. The CRISS measures key clinical disease parameters and patient-reported outcomes (PROs).