idiopathic inflammatory myopathy
Conditions
Interventions
Experimental Group:Tacrolimus combined with small dose of Pirfenidone (200-300mg orally, 3 times a day)
Control Group:Pirfenidone
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meet the Bohan and Peter diagnostic criteria (1975) or the EULAR/ACR diagnostic criteria (2017) for idiopathic inflammatory myopathy; 2.Aged 18-80 years; 3.Interstitial pulmonary disease (ILD) was confirmed by high resolution lung CT (HRCT); 4.Patients volunteered to participate in this study, with good compliance, and were able to understand and sign the informed consent before the study.
Exclusion criteria
Exclusion criteria: 1.Creatinine clearance less than 30 mL/min; 2.For liver diseases of clinical significance, abnormalities in liver function examination should be suggested (researchers should specify the examination items and range of abnormalities); 3.Patients with other severe lung diseases or other airway obstruction diseases; 4.Complicated with malignant tumor, while taking anti-tumor drugs or other immunoregulatory therapies; 5.Evidence of tuberculosis infection; 6.Suffers from serious immunosuppressive diseases, including HIV infection; 7.Have previously received hematopoietic stem cell transplantation (HSCT) or plan to receive HSCT in the following year; 8.Major surgery is planned during treatment; 9.Women who were pregnant, breastfeeding or planning to become pregnant during the study period; 10.Women of reproductive age are unwilling or unable to use highly effective contraceptive methods during the medication period; 11.Alcoholism or substance abuse, according to the investigator; 12.Patients who cannot understand or follow the study procedures; 13.Have any history of gastrointestinal diseases that affect drug absorption; 14.Patients with contraindications to the use of tacrolimus and pirfenidone; 15.Any other situation that the investigator considers inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function parameters;All-cause mortality;Severe adverse events;The recurrence rate;Immunological parameters;Myositis Scale score; | — |
Countries
China
Contacts
Public ContactDong Lingli
Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed