NCT05505409

Efficacy and Safety of Pirfenidone in CTD-ILD

Efficacy, Safety, Immune Function of Pirfenidone in the Treatment of Connetive Tissue Disease -Related Interstitial Lung Disease(CTD-LID)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-center randomized controlled study will be used to observe the efficacy and safety of pirfenidone on CTD-ILD patients for 24 months. The main research endpoints is the lung function (FVC) at 6 months. The clinical dyspnea score, 6-minute walking distance, index of lung function and imaging indicators are evaluated, as well as primary disease activity and adverse reactions of therapy with glucocorticoid and immunosuppressants up to 24 months.

Detailed description

A total of 120 Chinese patients with connective tissue disease-associated interstitial lung disease (CTD-ILD), including inflammatory myopathy (IIM), rheumatoid arthritis (RA), systemic sclerosis (SSc), and other connective tissue diseases, will be enrolled to use Pirfenidone or not in this study according to 2:1 random entry. Glucocorticoid and immunosuppressants worked as background treatment. The main research endpoint is the lung function (FVC) at 6 months. The clinical dyspnea score, 6-minute walking distance, lung function and imaging indicators, primary disease activity index are evaluated regularly until 24 months. The relationship of pirfenidone concentration, clinical effect and safety, immune function will be analyzed also.

Conditions

• Pirfenidone
• Connective Tissue Diseases
• Interstitial Lung Disease

Interventions

Type	Name	Description
DRUG	Pirfenidone	Drug:pirfenidone CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease
DRUG	glucocorticoid and immunosuppressant	Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease

Timeline

• Start date: 2022-06-22
• Primary completion: 2025-06-30
• Completion: 2025-12-01
• First posted: 2022-08-17
• Last updated: 2022-11-30

Locations

1 site across 1 country: China