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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03274076` - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)	Phase 1/Phase 2
Completed	`NCT04300426` - Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)	Phase 2
Recruiting	`NCT06058091` - RY_SW01 Cell Injection Therapy in Systemic Sclerosis	Phase 1/Phase 2
Recruiting	`NCT04356755` - Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.	Phase 2
Suspended	`NCT06210945` - Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis	Phase 2
Not yet recruiting	`NCT05947682` - Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis	N/A
Not yet recruiting	`NCT05177380` - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis	N/A
Not yet recruiting	`NCT04303208` - Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis	N/A
Recruiting	`NCT02551042` - CSL Behring Sclero XIII	Phase 2
Terminated	`NCT02243111` - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound	N/A
Terminated	`NCT02246348` - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)	N/A
Completed	`NCT01933334` - Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)	Phase 2
Completed	`NCT01468792` - Hemodynamic Changes in Connective Tissue Disease	N/A
Terminated	`NCT00848107` - Open-Label Study of Oral Treprostinil in Digital Ulcers	Phase 2
Completed	`NCT00984932` - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension	Phase 3
Completed	`NCT00074568` - Scleroderma Registry
Not yet recruiting	`NCT06412614` - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated	`NCT00622687` - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis	Phase 2
Recruiting	`NCT04464434` - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis	Phase 4
Recruiting	`NCT04246528` - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)	N/A