Immunosuppressant Combined With Pirfenidone in CTD-ILD

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    200
  • sponsor
    Qilu Hospital of Shandong University
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Updated on 24 June 2021
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immunosuppressive
dyspnea
rheumatism
progressive systemic sclerosis
pirfenidone

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.

Description

This study will enroll 200 cases of connective tissue disease-related interstitial lung disease (CTD-ILD) patients in China, including inflammatory myopathy (IIM) patients, rheumatoid arthritis (RA) patients, systemic sclerosis (SSc) patients, Sjogren's syndrome (SS) patients and other connective tissue disease patients.According to the patient's condition,the participants plan to be treated with different immunosuppressive agents with/wo pirfenidone .Participants can choose to continue the study up to 36 months.The efficacy and safety of the treatment in CTD-ILD patients will be evaluated with lung function, quality of life / cardiopulmonary function assessment and other disease activity indices.

Details
Condition CONNECTIVE TISSUE DISEASE, interstitial lung diseases, Interstitial lung disease, Pulmonary Fibrosis, Connective Tissue Diseases, Pirfenidone, connective tissue disorder, Pulmonary Disease, Dermatomyositis (Connective Tissue Disease), Lung Disease
Treatment Pirfenidone, DMARDs
Clinical Study IdentifierNCT04928586
SponsorQilu Hospital of Shandong University
Last Modified on24 June 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients who meet the following inclusion criteria will be eligible to participate in the study
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

Patients who meet any of the following criteria will be excluded from the study
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
Gastrointestinal tract: With active peptic ulcer or bleeding
Blood system: Severe anemia, decreased white blood cells and platelets
Nervous system: Patients with mental disorders; cerebral thrombosis events within the past 1 year
Combined with poor prognosis of diseases, such as cancer, genetic diseases and so on
Women during pregnancy or lactation or childbearing age cannot ensure effective contraception
According to the researchers, exhibited evidence of alcohol or drug abuse
Any other major medical events beyond control
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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