Enrichment Strategy for Systemic Sclerosis Clinical Trials Targeting Skin Fibrosis: A Prospective, Multiethnic Cohort Study
Abstract
The modified Rodnan skin score (mRSS) is often used as a primary outcome measure in systemic sclerosis (SSc) randomized clinical trials (RCTs). Previous cohort studies with predominantly European Caucasian patients showed that setting an upper limit of mRSS as a selection criterion for RCTs leads effectively to enrichment with progressive patients. This study aimed to demonstrate this effect in an ethnically diverse cohort, rich in patients positive for anti‐RNA polymerase III antibodies (Pol3).
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Jul 28, 2020
- Source ID
- 10.1002/acr2.11165
Entities
People
- Anastasiia Kozlova
- Carina Mihai
- Maureen D Mayes
- Rucsandra Dobrota
- Shervin Assassi
Organizations
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- United States Department of Defense
- University Hospital Zurich
- University of Texas at Austin