Immunosuppressant Combined With Pirfenidone in CTD-ILD

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04928586

Collaborator

(none)

200

Enrollment

Location

Arms

69.5

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pirfenidone Connective Tissue Diseases Interstitial Lung Disease	Drug: Pirfenidone Drug: DMARDs	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy, Safety and Predictive Indicators of Immunosuppressant Combined With Pirfenidone in the Treatment of Connective Tissue Disease-related Interstitial Lung Disease (CTD-ILD)

Actual Study Start Date :

Aug 16, 2019

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pirfenidone group CTD-ILD patients treated with DMARDs and pirfenidone	Drug: Pirfenidone CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose Drug: DMARDs CTD-ILD patients treated with DMARDs according to the condition of the disease
Active Comparator: No-Pirfenidone group CTD-ILD patients treated with DMARDs, without pirfenidone	Drug: DMARDs CTD-ILD patients treated with DMARDs according to the condition of the disease

Arm

Intervention/Treatment

Experimental: Pirfenidone group

CTD-ILD patients treated with DMARDs and pirfenidone

Drug: Pirfenidone

CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose

Drug: DMARDs

CTD-ILD patients treated with DMARDs according to the condition of the disease

Active Comparator: No-Pirfenidone group

CTD-ILD patients treated with DMARDs, without pirfenidone

Drug: DMARDs

CTD-ILD patients treated with DMARDs according to the condition of the disease

Outcome Measures

Primary Outcome Measures

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

Changes in FVC [6 months，24 months，36 months]
Changes from baseline in forced vital capacity(FVC)
Changes in DLCo [6 months，24 months，36 months]
Changes from baseline in carbon monoxide diffusing capacity (DLCo)
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.
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 Erythrocyte Sedimentation Rate(ESR) [6 months，12 months, 24 months，36 months]
Changes from baseline in Erythrocyte Sedimentation Rate(ESR)
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Aged 18-80 years;
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);
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:

Subjects have non-diffuse connective tissue disease or other arthritis other than RA, such as ANCA-relateed vasculitis, psoriatic arthritis, etc;
Patients who have ILD with clear etiology, such as HIV, GVHD ；
Combined viscera function significantly abnormal patient:
Liver: AST, ALT >1.3ULN; Bilirubin >1.5 ULN; or previous diagnosis of viral hepatitis;
Kidney: Creatinine clearance <30 mL/min;
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;
Cardiovascular: Myocardial infarction or unstable angina within six months;
Gastrointestinal tract: With active peptic ulcer or bleeding;
Blood system: Severe anemia, decreased white blood cells and platelets
Nervous system: Patients with mental disorders; cerebral thrombosis events within the past 1 year;
Combined with poor prognosis of diseases, such as cancer, genetic diseases and so on;
Women during pregnancy or lactation or childbearing age cannot ensure effective contraception;
According to the researchers, exhibited evidence of alcohol or drug abuse;
Any other major medical events beyond control;