NCT04928586

Immunosuppressant Combined With Pirfenidone in CTD-ILD

Efficacy, Safety and Predictive Indicators of Immunosuppressant Combined With Pirfenidone in the Treatment of Connective Tissue Disease-related Interstitial Lung Disease (CTD-ILD)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pirfenidone
• Connective Tissue Diseases
• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Pirfenidone	CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose
DRUG	DMARDs	CTD-ILD patients treated with DMARDs according to the condition of the disease

Timeline

• Start date: 2019-08-16
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2021-06-16
• Last updated: 2023-11-18

Locations

1 site across 1 country: China