Systemic sclerosis trial design moving forward

Author:

Johnson Sindhu R.1,Khanna Dinesh2,Allanore Yannick3,Matucci-Cerinic Marco4,Furst Daniel E.5

Affiliation:

1. Toronto Scleroderma Program, Toronto Western Hospital, Mount Sinai Hospital, Department of Medicine, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario - Canada

2. Division of Rheumatology, University of Michigan Scleroderma Program, Ann Arbor, Michigan - USA

3. Rheumatology A Department, Paris Descartes University, Cochin Hospital, Paris - France

4. Department of Rheumatology AVC, Department of BioMedicine, Division of Rheumatology AOUC, Department of Medicine & Denothecentre, University of Florence, Florence - Italy

5. Division of Rheumatology, David Geffen School of Medicine, University of California Los Angeles, California - USA

Abstract

The 2013 American College of Rheumatology–European League Against Rheumatism (ACR–EULAR) classification criteria for systemic sclerosis (SSc) have shifted the construct of SSc. The new reality is that patients recruited for trials may not be so severe and not so advanced. We can now look for therapeutics that might stop disease evolution and/or prevent organ involvement. This article highlights recent advances in research methodology, and broadens the potential range of design and analytic considerations when planning an SSc trial.

Publisher

SAGE Publications

Subject

Immunology,Rheumatology,Immunology and Allergy

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