UnknownPhase 3

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

China152 participantsStarted 2018-06-05

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Subjects not fulfill all of the above inclusion criteria
✕. 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;

What they're measuring

Relative change from baseline (%) of FVC

Timeframe: 52 Weeks

Trial details

NCT IDNCT03857854

SponsorBeijing Continent Pharmaceutical Co, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02

View on ClinicalTrials.gov More Dermatomyositis Interstitial Lung Disease (Dm-ILD) trials