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The purpose of this study is to evaluate the efficacy and safety of pirfenidone in subjects with dermatomyositis interstitial lung disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | pirfenidone group |
|
| placebo group | Placebo Comparator | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | treatment group |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline (%) of FVC | 52 Weeks |
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Inclusion Criteria:
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:
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
Within 3 months to participate in other clinical trials;
Combined medication: hormone > 15mg/d, were less than 1 months before a stable dose of patients; the use of other immunosuppressive agents (except cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, methotrexate and) patients; immunosuppression stable < 3 months; during the study of hormones and immunosuppressive agents are likely to increase patients.
Major surgery is planned during the treatment period.
Pregnancy or lactation or make a schedule during the trials.
Give the drug 28 days before or after administration of the 3 month period, women of childbearing age * are unwilling or unable to use contraceptive methods highly effective (according to ICH M3 (R2)), a highly effective means in the correct and consistent application of a barrier method when the failure rate of less than 1% per year. * women of childbearing age is defined has undergone menarche and in line with "infertile women" standard "[female infertile women" is defined as: postmenopausal period (12 months without menstruation, no other medical reasons) or permanent sterilization (e.g., tubal occlusion, hysterectomy, bilateral ovarian resection or bilateral tubal resection women)].
According to the researchers,exhibited evidence of alcohol or drug abuse.
Patients who were unable to understand or comply with the study procedures, including the completion of a self-administered questionnaire in the absence of help, were less likely to complete the trial.
Severe limb weakness or joint disease that affects the stability and endurance of a patient who is unable to perform a 6 minute walking test.
Clinical signs of malabsorption or needing parenteral nutrition.
Patients who were unable to cope with pulmonary function tests.
With mental illness .
Researchers determined that they did not participate in the trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhang, Ling | Recruiting | Beijing | Beijing Municipality | 100102 | China |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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| Drug |
placebo group |
|