Efficacy and Safety of Pirfenidone in CTD-ILD

NCT05505409 | Unknown Phase 4

• 1 other identifier: PFD-CTD-ILD QiluH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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 (1)

• Change in FVC%

  change in percentage of forced vital capacity (FVC) from 6 months to baseline

  6 months

Secondary Outcomes (18)

• Change in FVC %

  3months 12 months 24 months

• change in FEV1%、DLco%、TLC%

  3months 6months 12months 24months

• Proportion of patients and time with a decrease in DLco%

  3months 6months 12months 24months

• Proportion of patients and time with a decrease in FVC%

  3months 6months 12months 24months

• Progression-free survival

  up to 24months

Study Arms (2)

pirfenidone group

EXPERIMENTAL

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

Drug: Pirfenidone; Drug: glucocorticoid and immunosuppressant

No-pirfenidone group

ACTIVE COMPARATOR

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

Drug: glucocorticoid and immunosuppressant

Interventions

Pirfenidone 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

Also known as: glucocorticoid and immunosuppressant

pirfenidone group

glucocorticoid and immunosuppressant DRUG

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

No-pirfenidone group; pirfenidone group

Eligibility Criteria

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

You may not qualify if:

• \. Subjects have systemic vasculitis, other arthritis other than CTD or RA such AS psoriatic arthritis, SPA, AS, SLE and pSS;
• \. ILD patients with other obvious causes, such as HIV, GVHD, etc.
• \. Patients with obvious abnormal combined organ function;
• Liver :AST, ALT, R-GT, bilirubin at 1.5 ULN, or previously diagnosed viral hepatitis;
• Kidney: creatinine clearance rate 30ml /min;
• 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;
• Cardiovascular: myocardial infarction within 6 months;
• gastrointestinal tract: active peptic ulcer or bleeding;
• Blood system: severe anemia, leukopenia, thrombocytopenia;
• Nervous system: patients with mental disorders; Cerebral thrombotic events (stroke and transient ischemic attack) within the last 1 year;
• \. Tuberculosis, cancer, hereditary diseases and other diseases with poor prognosis;
• \. Effective contraception cannot be guaranteed during pregnancy, lactation or childbearing age;
• \. Evidence of alcohol or drug abuse, according to the researchers;
• \. Allergic to glucocorticoids, immunosuppressants and PFD;
• \. Unable to complete regular follow-up and post-treatment pulmonary function tests;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

pirfenidone; Glucocorticoids; Immunosuppressive 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)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Immunologic Factors

Study Officials

• xiaoyun yang, Dr

  Study Principal Investigator Qilu HOspital of Shandong Uniwersity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Shu, Dr

CONTACT

0086-0531-82169654; shuqiang@sdu.edu.cn

keke xie

CONTACT

0086-0531-82169654; 695052518@qq.com

Study Design

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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: June 22, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 1, 2025
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CN (1)