Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

Status Not yet recruiting

Clinical Trial Summary

This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.

Clinical Trial Description

All patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage.

The study period is 52 week. The study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. Subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids.

The secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03068234
Study type	Interventional
Source	RenJi Hospital
Contact
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	May 2017
Completion date	December 2019

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See also
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