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PirfenidonePhase 4NCT04928586

Immunosuppressant Combined With Pirfenidone in CTD-ILD

A Phase 4 study testing Pirfenidone and DMARDs in people with Pirfenidone and Connective Tissue Diseases, run by Qilu Hospital of Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pirfenidone and DMARDs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
16 Aug 2019to 1 Jun 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 15Show fewer
  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu Hospital

    Jinan, Shandong, 250012

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
Pirfenidone, DMARDs
Keywords
pirfenidone, interstitial lung disease, connective tissue disease, rheumatoid arthritis, systemic sclerosis, inflammatory myopathy
Medical subject headings
Connective Tissue Diseases, Lung Diseases, Interstitial, Arthritis, Rheumatoid, Scleroderma, Systemic, Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirfenidoneDrug

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

  • DMARDsDrug

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

Study groups in NCT04928586
Study groupRoleWhat they receive
Pirfenidone groupExperimentalCTD-ILD patients treated with DMARDs and pirfenidone
Receives: Drug: Pirfenidone; Drug: DMARDs
No-Pirfenidone groupActive comparatorCTD-ILD patients treated with DMARDs, without pirfenidone
Receives: Drug: DMARDs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in FVC

    Change in forced vital capacity(FVC) from 12 months to baseline

    Measured: 12 months

  2. Change in DLCo

    Change in carbon monoxide diffusing capacity (DLCo) from 12 months to baseline

    Measured: 12 months

Secondary outcomes (9)

  1. Changes in FVC

    Changes from baseline in forced vital capacity(FVC)

    Measured: 6 months，24 months，36 months

  2. Changes in DLCo

    Changes from baseline in carbon monoxide diffusing capacity (DLCo)

    Measured: 6 months，24 months，36 months

  3. 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.

    Measured: 6 months，12 months, 24 months，36 months

  4. Imaging changes

    Changes from baseline in high-resolution computed tomography (HRCT)

    Measured: 6 months，12 months, 24 months，36 months

  5. Changes from baseline in 6 minutes walking distance

    Changes from baseline in 6 minutes walking distance

    Measured: 6 months，12 months, 24 months，36 months

  6. Changes from baseline in C-reactive protein(CRP)

    Changes from baseline in C-reactive protein(CRP)

    Measured: 6 months，12 months, 24 months，36 months

  7. Changes from baseline in Erythrocyte Sedimentation Rate(ESR)

    Changes from baseline in Erythrocyte Sedimentation Rate(ESR)

    Measured: 6 months，12 months, 24 months，36 months

  8. 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.

    Measured: 6 months，12 months, 24 months，36 months

  9. 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.

    Measured: Up to month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start16 Aug 2019
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04928586
Sponsor's protocol ID
CTD-ILD QiluH
Status last verified
Nov 2023
First submitted
27 May 2021
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pirfenidone and DMARDs in people with Pirfenidone and Connective Tissue Diseases, run by Qilu Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FVC (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04928586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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