Efficacy and Safety of Pirfenidone in CTD-ILD

NCT ID: NCT05505409

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2025-12-01

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.

Conditions

Pirfenidone; Connective Tissue Diseases; Interstitial Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pirfenidone group

CTD-ILD patients treated with pirfenidone、glucocorticoid and immunosuppressant.

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: DRUG

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

glucocorticoid and immunosuppressant

Intervention Type: DRUG

Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease

No-pirfenidone group

CTD-ILD patients treated with glucocorticoid and immunosuppressant,without pirfebidone

Group Type: ACTIVE_COMPARATOR

glucocorticoid and immunosuppressant

Intervention Type: DRUG

Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease

Interventions

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

Intervention Type: DRUG

glucocorticoid and immunosuppressant

Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease

Intervention Type: DRUG

Other Intervention Names

glucocorticoid and immunosuppressant

Eligibility Criteria

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;

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

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

3. 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;

4. Cardiovascular: myocardial infarction within 6 months;

5. gastrointestinal tract: active peptic ulcer or bleeding;

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

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

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

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

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

7. Allergic to glucocorticoids, immunosuppressants and PFD;

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

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qiang Shu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xiaoyun yang, Dr

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Qilu HOspital of Shandong Uniwersity

Locations

Qilu Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Shu, Dr

Role: CONTACT

shuqiang@sdu.edu.cn

0086-0531-82169654

keke xie

Role: CONTACT

695052518@qq.com

0086-0531-82169654

Facility Contacts

xiaoyun yang

Role: primary

qlyykyc@163.com

+8653182169035

Other Identifiers

PFD-CTD-ILD QiluH

Identifier Type: -

Identifier Source: org_study_id