Immunosuppressant Combined With Pirfenidone in CTD-ILD

Phase 4

Active, not recruiting

• Conditions: Interstitial Lung Disease; Pirfenidone; Connective Tissue Diseases
• Interventions: Drug: Pirfenidone; Drug: DMARDs

• Registration Number: NCT04928586
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

A prospective cohort study was used to observe the efficacy and safety of different immunosuppressive agents with/wo pirfenidone on CTD-ILD patients in Qilu Hospital of Shandong University for 36 months.The main research endpoints are lung function, patient dyspnea score, 6-minute walking distance, imaging indicators, primary disease activity, adverse reactions, etc.

Detailed Description

This study will enroll 200 cases of connective tissue disease-related interstitial lung disease (CTD-ILD) patients in China, including inflammatory myopathy (IIM) patients, rheumatoid arthritis (RA) patients, systemic sclerosis (SSc) patients, Sjogren's syndrome (SS) patients and other connective tissue disease patients.According to the patient's condition,the participants plan to be treated with different immunosuppressive agents with/wo pirfenidone .Participants can choose to continue the study up to 36 months.The efficacy and safety of the treatment in CTD-ILD patients will be evaluated with lung function, quality of life / cardiopulmonary function assessment and other disease activity indices.

Study Timeline

• Study Start: 2019-08-16
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who meet the following inclusion criteria will be eligible to participate in the study:

  1. Aged 18-80 years;
  2. In accordance with the diagnostic criteria of connective tissue disease-related pulmonary interstitial disease (CTD-ILD);The diagnosis of CTD is in line with the international classification standard of rheumatism (including inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, sjogren's syndrome, systemic lupus erythematosus, mixed connective tissue disease, undifferentiated connective tissue disease);
  3. Subjects are willing to participate and use medication and follow-up time according to the treatment plan, and sign the informed consent;

Exclusion Criteria

• Patients who meet any of the following criteria will be excluded from the study:

  1. Subjects have non-diffuse connective tissue disease or other arthritis other than RA, such as ANCA-relateed vasculitis, psoriatic arthritis, etc;

  2. Patients who have ILD with clear etiology, such as HIV, GVHD ；

  3. Combined viscera function significantly abnormal patient:

     1. Liver: AST, ALT >1.3ULN; Bilirubin >1.5 ULN; or previous diagnosis of viral hepatitis;
     2. Kidney: Creatinine clearance <30 mL/min;
     3. Lung: Airway obstruction (pre-bronchodilator FEV1/FVC <0.7); pleural effusion accounts for more than 20% of pleural effusion ;severe pulmonary infection or other clinically significant pulmonary abnormalities;
     4. Cardiovascular: Myocardial infarction or unstable angina within six months;
     5. Gastrointestinal tract: With active peptic ulcer or bleeding;
     6. Blood system: Severe anemia, decreased white blood cells and platelets
     7. Nervous system: Patients with mental disorders; cerebral thrombosis events within the past 1 year;

  4. Combined with poor prognosis of diseases, such as cancer, genetic diseases and so on;

  5. Women during pregnancy or lactation or childbearing age cannot ensure effective contraception;

  6. According to the researchers, exhibited evidence of alcohol or drug abuse;

  7. Any other major medical events beyond control;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirfenidone group	DMARDs	CTD-ILD patients treated with DMARDs and pirfenidone
No-Pirfenidone group	DMARDs	CTD-ILD patients treated with DMARDs, without pirfenidone
Pirfenidone group	Pirfenidone	CTD-ILD patients treated with DMARDs and pirfenidone

Primary Outcome Measures

Name	Time	Method
Change in FVC	12 months	Change in forced vital capacity(FVC) from 12 months to baseline
Change in DLCo	12 months	Change in carbon monoxide diffusing capacity (DLCo) from 12 months to baseline

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Erythrocyte Sedimentation Rate(ESR)	6 months，12 months, 24 months，36 months	Changes from baseline in Erythrocyte Sedimentation Rate(ESR)
Number of participants with "adverse events (AEs)"	Up to month 36	An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Changes from baseline in Dyspnea score	6 months，12 months, 24 months，36 months	Changes from baseline in Dyspnea score. Dyspnea score:activity tolerance of patients with dyspnea in daily life: 0: normal, 1: dyspnea when climbing the fifth floor, 2: dyspnea when climbing the third floor, 3: dyspnea when climbing the second floor, 4: Difficulty in breathing when walking on the flat ground 100-500m, 5: Difficulty in breathing when walking on flat ground for 50-100m, 6: Difficulty in breathing when walking on flat ground for 15-50m, 7: Difficulty in breathing when walking on flat ground 5-15m, 8: Difficulty in breathing during daily dressing, 9: Difficulty in breathing when eating, 10: Difficulty in breathing when resting.The higher the score, the more severe the disease.
Changes in DLCo	6 months，24 months，36 months	Changes from baseline in carbon monoxide diffusing capacity (DLCo)
Imaging changes	6 months，12 months, 24 months，36 months	Changes from baseline in high-resolution computed tomography (HRCT)
Changes from baseline in 6 minutes walking distance	6 months，12 months, 24 months，36 months	Changes from baseline in 6 minutes walking distance
Changes from baseline in C-reactive protein(CRP)	6 months，12 months, 24 months，36 months	Changes from baseline in C-reactive protein(CRP)
Changes from baseline in VAS score	6 months，12 months, 24 months，36 months	The visual analogue scale (VAS) is used for pain assessment. The basic method is to use a moving ruler with a length of about 10cm. One side is marked with 10 scales. The two ends are respectively "0" and "10" points. A point of 0 means no pain, and a point of 10 means the most unbearable. Severe pain. It can reflect the degree of activity of the primary disease.
Changes in FVC	6 months，24 months，36 months	Changes from baseline in forced vital capacity(FVC)

Trial Locations

Locations (1)

Qilu Hospital; 🇨🇳 Jinan, Shandong, China