Immunosuppressant Combined With Pirfenidone in CTD-ILD

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Pirfenidone

DMARDs

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

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 C-reactive protein(CRP)

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