Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03068234
• Other study ID #: [2017]17
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: February 16, 2017
• Last updated: February 24, 2017
• Start date: May 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).

• Subjects must have mRSS=10 at screening stage

• Subjects must have signs of fibrosis in their chest CT at screening stage

• If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (?mRSS=-2)

Exclusion Criteria:

• Subjects with other connective tissue diseases overlapping with SSc

• Subjects with skin atrophy as the main cutaneous manifestation

• Subjects with active digital ulcers or gangrene

• Active severe SSc-driven renal disease or heart dysfunction at screening

• Subjects with significant hematologic abnormalities

• Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level

• Clinically significant active infection including ongoing and chronic infections

• History of human immunodeficiency virus (HIV)

• Confirmed Positive tests for hepatitis B or positive test for hepatitis C

• Active tuberculosis

• Live or attenuated vaccine within 4 weeks prior to screening

• Subjects with significant hematologic abnormalities

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Pirfenidone
A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.
• Placebo oral capsule
Placebo for pirfenidone capsule
• Steroids
Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rodnan Skin Score (mRSS)	A semi-quantitative score for skin fibrosis of every subjects	Week 52
Secondary	Modified Rodnan Skin Score	A semi-quantitative score for skin fibrosis of every subjects	Week 24
Secondary	Assessment of chest CT	Semi-quantitative scale for fibrotic changes in chest CT images from an individual patient	Week 52
Secondary	Assessment of chest CT	Semi-quantitative scale for fibrotic changes in chest CT images from an individual patient	Week 24
Secondary	Forced vital capacity	A marker for lung function that may decrease with pulmonary fibrosis	Week 52
Secondary	Forced vital capacity	A marker for lung function that may decrease with pulmonary fibrosis	Week 24
Secondary	Diffusing capacity	Another marker for lung function that may decrease with pulmonary fibrosis	Week 52
Secondary	Diffusing capacity	Another marker for lung function that may decrease with pulmonary fibrosis	Week 24
Secondary	6 minute walk test	A simple, well-accepted and quantitative clinical exam to test heart and lung function	Week 52
Secondary	6 minute walk test	A simple, well-accepted and quantitative clinical exam to test heart and lung function	Week 24
Secondary	Hand function assessment	Hand function will be measured by Cochin Hand Function Scale	Week 52
Secondary	Hand function assessment	Hand function will be measured by Cochin Hand Function Scale	Week 24
Secondary	Proportion of subjects with increased mRSS	Proportion of subjects with ?mRSS=5	Week 52
Secondary	Proportion of subjects with increased mRSS	Proportion of subjects with ?mRSS=5	Week 24
Secondary	Quality of life	Assessed by the health assessment questionnaire disability index	Week 52
Secondary	Quality of life	Assessed by the health assessment questionnaire disability index	Week 24
Secondary	Safety and Tolerability	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Week 52
Secondary	Safety and Tolerability	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Week 24