Immunosuppressant Combined With Pirfenidone in CTD-ILD

NCT04928586 | Unknown Phase 4

• 1 other identifier: CTD-ILD QiluH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pirfenidone; Connective Tissue Diseases; Interstitial Lung Disease

Keywords

pirfenidone; interstitial lung disease; connective tissue disease; rheumatoid arthritis; systemic sclerosis; inflammatory myopathy

Outcome Measures

Primary Outcomes (2)

• Change in FVC

  Change in forced vital capacity(FVC) from 12 months to baseline

  12 months

• Change in DLCo

  Change in carbon monoxide diffusing capacity (DLCo) from 12 months to baseline

  12 months

Secondary Outcomes (9)

• Changes in FVC

  6 months，24 months，36 months

• Changes in DLCo

  6 months，24 months，36 months

• Changes from baseline in Dyspnea score

  6 months，12 months, 24 months，36 months

• Imaging changes

  6 months，12 months, 24 months，36 months

• Changes from baseline in 6 minutes walking distance

  6 months，12 months, 24 months，36 months

Study Arms (2)

Pirfenidone group

EXPERIMENTAL

CTD-ILD patients treated with DMARDs and pirfenidone

Drug: Pirfenidone; Drug: DMARDs

No-Pirfenidone group

ACTIVE COMPARATOR

CTD-ILD patients treated with DMARDs, without pirfenidone

Drug: DMARDs

Interventions

Pirfenidone DRUG

CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose

Pirfenidone group

DMARDs DRUG

CTD-ILD patients treated with DMARDs according to the condition of the disease

No-Pirfenidone group; Pirfenidone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Connective Tissue Diseases; Lung Diseases, Interstitial; Arthritis, Rheumatoid; Scleroderma, Systemic; Myositis

Interventions

pirfenidone; Antirheumatic Agents

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Lung Diseases; Respiratory Tract Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Yang Xiaoyun, Dr.

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 16, 2021
• Study Start: August 16, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)