Efficacy and Immune Function of Pirfenidone in CTD-ILD

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A single-center randomized controlled study was used to observe the efficacy and immune function with/wo pirfenidone on CTD-ILD patients in QIlu Hospital of Shanndong University for 24 months. The main research endpoints are lung function ,patient dyspnea score,imaging indicators and so on.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Hospital of Shandong University
• Treatments: Glucocorticoids; Immunosuppressive Agents; Pirfenidone

Criteria

Inclusion Criteria:

1. Be at least 18 years old ;

2. Conform to several diagnostic criteria of CTD(RA,IIM,SSc) and UCTD/IPAF classification criteria;

3. HRCT diagnosis was confirmed to be interstitial lung disease (ILD) with corresponding clinical manifestations;

4. Patients who can complete vital capacity (FVC) or carbon monoxide dispersion(DLco) test (using Hb correction);

5. ILD patients with clinical deterioration more than 1 month after diagnosis, or poor response or intolerance after previous GC and IS treatment, or poor response or intolerance to other anti-fibrosis drugs (for acetylhemioptic acid, nidanib, etc.), or effective previous use of PFD, clinical symptoms or ILD index aggravation after drug withdrawal for more than 3 months

6. If concomitant therapy with IS was used, the dose was stable for at least 4 weeks before the baseline period. The types of immunomodulator hydroxychloroquine (HCQ) or immunosuppressive agents are MMF, TAC, JAKi, CTX, LEF, AzA, Elamud, etc.

7. Concomitant hormones: IIM patients with hormone dose (calculated as prednisone equivalent dose) ≤60mg/d and relatively stable disease; For other CTD patients, the hormone dose (calculated as prednisone equivalent dose) was ≤40mg/ day for at least 1 month

Exclusion Criteria:

1. Subjects had systemic vasculitis, 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 organ dysfunction;

(1) Liver :AST, ALT, R-GT, bilirubin at 1.5 ULN, or previously diagnosed with viral hepatitis; (2) Kidney: creatinine clearance rate was 30ml /min; (3) Lung: airway obstruction (pre-bronchodilator FEV1/FVC LT; 0.7), pleural effusion accounts for more than 20% of pleural effusion, severe lung infection or other clinically significant lung abnormalities; (4) Cardiovascular disease: 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 thrombosis events (stroke and transient ischemic attack) within the last 1 year; 4. Diseases with poor prognosis, such as tuberculosis, cancer and genetic diseases; 5. Effective contraception cannot be guaranteed during pregnancy, lactation or childbearing age; 6. Evidence of alcohol or drug abuse, according to the researcher; 7. Allergic to glucocorticoids, immunosuppressants and PFD; 8. Patients who cannot complete regular follow-up and post-treatment lung function test; 9. Patients using PFD who were not included in the efficacy analysis but included in the safety analysis: those who had been using PFD for less than 3 months 6 months prior to the primary endpoint; The duration of use was less than 3 months and the total duration of use was less than 6 months before the 24th month of study end.

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