Efficacy and Safety of Pirfenidone in CTD-ILD

Phase 4

Recruiting

• Conditions: Pirfenidone; Connective Tissue Diseases; Interstitial Lung Disease
• Interventions: Drug: glucocorticoid and immunosuppressant; Drug: Pirfenidone

• Registration Number: NCT05505409
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Study Timeline

• Study Start: 2022-06-22
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-27
• Last Update Posted: 2022-11-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Subjects have systemic vasculitis, other arthritis other than CTD or RA such AS psoriatic arthritis, SPA, AS, SLE and pSS;

2. ILD patients with other obvious causes, such as HIV, GVHD, etc.

3. Patients with obvious abnormal combined organ function;

4. Liver :AST, ALT, R-GT, bilirubin at 1.5 ULN, or previously diagnosed viral hepatitis;

5. Kidney: creatinine clearance rate 30ml /min;

6. Lung: airway obstruction (pre-bronchodilator FEV1/FVC & LT; 0.7), pleural effusion accounted for more than 20% of pleural effusion, severe pulmonary infection or other clinically significant pulmonary abnormalities;

7. Cardiovascular: myocardial infarction within 6 months;

8. gastrointestinal tract: active peptic ulcer or bleeding;

9. Blood system: severe anemia, leukopenia, thrombocytopenia;

10. Nervous system: patients with mental disorders; Cerebral thrombotic events (stroke and transient ischemic attack) within the last 1 year;

11. Tuberculosis, cancer, hereditary diseases and other diseases with poor prognosis;

12. Effective contraception cannot be guaranteed during pregnancy, lactation or childbearing age;

13. Evidence of alcohol or drug abuse, according to the researchers;

14. Allergic to glucocorticoids, immunosuppressants and PFD;

15. Unable to complete regular follow-up and post-treatment pulmonary function tests;

16. PFD users not included in the efficacy analysis but included in the safety analysis: those who had used PFD for less than 3 months 6 months before the primary endpoint; The duration of use was less than 3 months before the 24th month of the syudy and the total duration of use was less than 6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No-pirfenidone group	glucocorticoid and immunosuppressant	CTD-ILD patients treated with glucocorticoid and immunosuppressant,without pirfebidone
pirfenidone group	glucocorticoid and immunosuppressant	CTD-ILD patients treated with pirfenidone、glucocorticoid and immunosuppressant.
pirfenidone group	Pirfenidone	CTD-ILD patients treated with pirfenidone、glucocorticoid and immunosuppressant.

Primary Outcome Measures

Name	Time	Method
Change in FVC%	6 months	change in percentage of forced vital capacity (FVC) from 6 months to baseline

Secondary Outcome Measures

Name	Time	Method
Advances in imaging	3 months 6months 12months 24months	The proportion of patients with disease progression on imaging at each time point compared with baseline
Proportion of patients and time with a decrease in FVC%	3months 6months 12months 24months	Percentage of patients and time with FVC% decreased\>10% compared to baseline
changes from baseline in 6 minutes walking distance	3months 6months 12months 24months	changes from baseline in 6 minutes walking distance
change in pulse oxygen saturation	up to 24months	the worst oxygen saturation as measured by pulse oxygen saturation(SpO2) was observed during 6 minutes walking distance
Imaging changes	6months 12months 24months	changes from baseline in high-resolution computed tomography (HRCT)
Proportion of patients and time with a decrease in DLco%	3months 6months 12months 24months	Percentage of patients and time with DLco% decreased\>15% compared to baseline
Progression-free survival	up to 24months	survival with a predicated absolute FVC% decrease of no more than 10% from baseline,and a predicated absolute DLco% decrease of no more than 15% from baseline
clinical deteriorration	up to 24months	The time and incidence of the first clinical deterioration ,Number of clinical exacerbations,Time between the all-cause deaths
Changes from baseline in C-reactive protein (CRP),Erythrocyte Sedimentation Rate(ESR),Inflammatory factors and indicators.	3 months 6months 12months 24months	Changes from baseline in C-reactive protein (CRP),Erythrocyte Sedimentation Rate(ESR),Inflammatory factors and indicators.
change in FEV1%、DLco%、TLC%	3months 6months 12months 24months	change from baseline in carbon monoxide diffusing capacity (DLco)、FEV1、TLC
change in absolute value of FVC and DLco	3months 6months 12months 24months	absolute value change of FVC(ml) and DLco(ml) at each time point and annual decline rate compared with baseline
Predicators of pirfenidone response in each disease subgroup	3months 6months 12months 24months	Predicators of pirfenidone response in each disease subgroup
Change in FVC %	3months 12 months 24 months	change from baseline in percentage of forced vital capacity (FVC)
Worsening respiratory symptoms	3 months 6months 12months 24months	Proportion of patients with worsening respiratory symptoms at each time point compared with baseline
Borg dyspnea Index score	3 months 6months 12months 24months	cChange of Borg dyspnea index score at each time point compared with baseline
Adverse events , timing,type,extent,frequency,and outcome of SAE	up to 24months	Adverse events , timing,type,extent,frequency,and outcome of SAE
FVC% area under the curve	3months 6months 12months 24months	forced vital capacity (FVC)% area under the curve
Changes from baseline in primary disease activity	up to 24months	Changes from baseline in primary disease activity

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China