Immunosuppressant Combined With Pirfenidone in CTD-ILD
Primary Purpose
Pirfenidone, Connective Tissue Diseases, Interstitial Lung Disease
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Pirfenidone
DMARDs
Sponsored by
About this trial
This is an interventional treatment trial for Pirfenidone focused on measuring pirfenidone, interstitial lung disease, connective tissue disease, rheumatoid arthritis, systemic sclerosis, inflammatory myopathy
Eligibility Criteria
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;
Sites / Locations
- Qilu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pirfenidone group
No-Pirfenidone group
Arm Description
CTD-ILD patients treated with DMARDs and pirfenidone
CTD-ILD patients treated with DMARDs, without pirfenidone
Outcomes
Primary Outcome Measures
Change in FVC
Change in forced vital capacity(FVC) from 12 months to baseline
Change in DLCo
Change in carbon monoxide diffusing capacity (DLCo) from 12 months to baseline
Secondary Outcome Measures
Changes in FVC
Changes from baseline in forced vital capacity(FVC)
Changes in DLCo
Changes from baseline in carbon monoxide diffusing capacity (DLCo)
Changes from baseline in Dyspnea score
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
Changes from baseline in high-resolution computed tomography (HRCT)
Changes from baseline in 6 minutes walking distance
Changes from baseline in 6 minutes walking distance
Changes from baseline in C-reactive protein(CRP)
Changes from baseline in C-reactive protein(CRP)
Changes from baseline in Erythrocyte Sedimentation Rate(ESR)
Changes from baseline in Erythrocyte Sedimentation Rate(ESR)
Changes from baseline in VAS score
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)"
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.
Full Information
NCT ID
NCT04928586
First Posted
May 27, 2021
Last Updated
June 9, 2021
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT04928586
Brief Title
Immunosuppressant Combined With Pirfenidone in CTD-ILD
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pirfenidone, Connective Tissue Diseases, Interstitial Lung Disease
Keywords
pirfenidone, interstitial lung disease, connective tissue disease, rheumatoid arthritis, systemic sclerosis, inflammatory myopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pirfenidone group
Arm Type
Experimental
Arm Description
CTD-ILD patients treated with DMARDs and pirfenidone
Arm Title
No-Pirfenidone group
Arm Type
Active Comparator
Arm Description
CTD-ILD patients treated with DMARDs, without pirfenidone
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Intervention Description
CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose
Intervention Type
Drug
Intervention Name(s)
DMARDs
Intervention Description
CTD-ILD patients treated with DMARDs according to the condition of the disease
Primary Outcome Measure Information:
Title
Change in FVC
Description
Change in forced vital capacity(FVC) from 12 months to baseline
Time Frame
12 months
Title
Change in DLCo
Description
Change in carbon monoxide diffusing capacity (DLCo) from 12 months to baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in FVC
Description
Changes from baseline in forced vital capacity(FVC)
Time Frame
6 months,24 months,36 months
Title
Changes in DLCo
Description
Changes from baseline in carbon monoxide diffusing capacity (DLCo)
Time Frame
6 months,24 months,36 months
Title
Changes from baseline in Dyspnea score
Description
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.
Time Frame
6 months,12 months, 24 months,36 months
Title
Imaging changes
Description
Changes from baseline in high-resolution computed tomography (HRCT)
Time Frame
6 months,12 months, 24 months,36 months
Title
Changes from baseline in 6 minutes walking distance
Description
Changes from baseline in 6 minutes walking distance
Time Frame
6 months,12 months, 24 months,36 months
Title
Changes from baseline in C-reactive protein(CRP)
Description
Changes from baseline in C-reactive protein(CRP)
Time Frame
6 months,12 months, 24 months,36 months
Title
Changes from baseline in Erythrocyte Sedimentation Rate(ESR)
Description
Changes from baseline in Erythrocyte Sedimentation Rate(ESR)
Time Frame
6 months,12 months, 24 months,36 months
Title
Changes from baseline in VAS score
Description
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.
Time Frame
6 months,12 months, 24 months,36 months
Title
Number of participants with "adverse events (AEs)"
Description
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.
Time Frame
Up to month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Shu, Dr.
Phone
0086-0531-82169654
Email
shuqiang@sdu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaqi Wang
Phone
0086-0531-82169654
Email
1940273314@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Xiaoyun, Dr.
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xiaoyun
Phone
+8653182169035
Email
qlyykyc@163.com
12. IPD Sharing Statement
Learn more about this trial
Immunosuppressant Combined With Pirfenidone in CTD-ILD
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