Immunosuppressant Combined With Pirfenidone in CTD-ILD (NCT04928586) | Clinical Trial Compass
UnknownPhase 4
Immunosuppressant Combined With Pirfenidone in CTD-ILD
China200 participantsStarted 2019-08-16
Plain-language summary
A prospective cohort study was used to observe the efficacy and safety of different immunosuppressive agents with/wo pirfenidone on CTD-ILD patients in Qilu Hospital of Shandong University for 36 months.The main research endpoints are lung function, patient dyspnea score, 6-minute walking distance, imaging indicators, primary disease activity, adverse reactions, etc.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged 18-80 years;
✓. In accordance with the diagnostic criteria of connective tissue disease-related pulmonary interstitial disease (CTD-ILD);The diagnosis of CTD is in line with the international classification standard of rheumatism (including inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, sjogren's syndrome, systemic lupus erythematosus, mixed connective tissue disease, undifferentiated connective tissue disease);
✓. Subjects are willing to participate and use medication and follow-up time according to the treatment plan, and sign the informed consent;
Exclusion criteria
✕. Subjects have non-diffuse connective tissue disease or other arthritis other than RA, such as ANCA-relateed vasculitis, psoriatic arthritis, etc;
✕. Patients who have ILD with clear etiology, such as HIV, GVHD ；
✕. Combined viscera function significantly abnormal patient:
✕. Liver: AST, ALT \>1.3ULN; Bilirubin \>1.5 ULN; or previous diagnosis of viral hepatitis;
✕. Kidney: Creatinine clearance \<30 mL/min;
✕. Lung: Airway obstruction (pre-bronchodilator FEV1/FVC \<0.7); pleural effusion accounts for more than 20% of pleural effusion ;severe pulmonary infection or other clinically significant pulmonary abnormalities;
✕. Cardiovascular: Myocardial infarction or unstable angina within six months;