Efficacy and Safety of Pirfenidone in Patient With Dermatomyositis Interstitial Lung Disease (Dm-ILD)

NCT03857854 | Unknown Phase 3

• 1 other identifier: GNI-F647-1702
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of pirfenidone in subjects with dermatomyositis interstitial lung disease

Conditions

Dermatomyositis Interstitial Lung Disease (Dm-ILD)

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline (%) of FVC

  52 Weeks

Study Arms (2)

treatment group

EXPERIMENTAL

pirfenidone group

Drug: Pirfenidone

placebo group

PLACEBO COMPARATOR

control group

Drug: Placebos

Interventions

Pirfenidone DRUG

treatment group

treatment group

Placebos DRUG

placebo group

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects aged between 18 and 65 years of age
• According to the 1975 Borhan and Peter inflammatory myopathy diagnosed as dermatomyositis classification criteria (dermatomyositis, DM); or according to the revised clinical criteria for diagnosis of Sontheimer disease dermatomyositis (CADM).
• The diagnosis of pulmonary related Interstitial Lung Disease confirmed by HRCT
• Forced vital capacity (FVC) 40% to 80% predicted(include 40% and80% )
• Carbon monoxide diffusing capacity (DLco) 30% to 89% of predicted normal(include 30% and89% )
• Has received Glucocorticoid (hereinafter referred to as the "hormone") and at least one immunosuppressive therapy for more than 3 months, the hormone dosage (prednisone equivalent dose calculation) should be less than 15mg/d for at least 1 months, should be immunosuppressant cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine and at least one of methotrexate in, and the type and dose of immunosuppressive agents should be at least stable more than 3 months. The hormone and immunosuppressant therapy scheme allows a reduction in the study period, but is not allowed to increase the volume.
• Women of childbearing age must agree and promise to use the form of medical care for at least 3 months after the trial, during the entire study period (including follow-up), and at the end of the trial.
• Patients volunteered to participate in the trial, with good compliance and ability to understand and sign informed consent before the study.

You may not qualify if:

• Combined with other rheumatic diseases such as systemic sclerosis, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, undifferentiated connective tissue disease, and systemic vasculitis, such as ANCA associated vasculitis.
• Combined with other muscle diseases and may cause symptoms of myasthenia gravis disease, including neurological diseases (such as muscular dystrophy, myasthenia gravis, amyotrophic lateral sclerosis, Guillain Barre syndrome), cancer, drugs (such as statins), infection, genetic diseases, endocrine disorders, electrolyte disorder rhabdomyolysis.
• The clinical history, signs, serological examination, HRCT and bronchoalveolar lavage results suggest that in addition to inflammatory myopathy and other diseases caused by ILD, such as CTD, systemic vasculitis, infection, tumor, allergic pneumonia caused by sarcoidosis or environmental factors.
• Combined viscera function significantly abnormal patient:
• Liver:AST, ALT \>1.3ULN;Bilirubin \>1.5 ULN; Cirrhosis of the liver class for Child Pugh C;
• Kidney:Creatinine clearance \<30 mL/min;
• Lung:Airway obstruction (pre-bronchodilator FEV1/FVC \<0.7);Other clinically significant pulmonary abnormalities;
• Cardiovascular:i.Six weeks in severe hypertension, and out of control after treatment(≥160/100mmHg);ii.Myocardial infarction within six months;iii.A period of 6 Months in unstable angina;iv.pulmonary artery hypertension and right heart failure were significant;
• Gastrointestinal tract: with active peptic ulcer;
• Nervous system: Patients with psychiatric disorders;
• The blood coagulation function: History of thrombotic event within last year(Including stroke and transient ischemic attack).
• Researchers, for other diseases (not inflammatory myopathy, such as malignant tumor) and make the life expectancy of \< 1 year of patients
• Allergic to test drugs or components (e.g. lactose)
• Patients with actinic dermatitis
• Previous treatment with nintedanib or pirfenidone

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (1)

Zhang, Ling

Beijing, Beijing Municipality, 100102, China

RECRUITING

MeSH Terms

Interventions

pirfenidone

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: June 5, 2018
• Primary Completion: February 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

CN (1)