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PirfenidonePhase 4NCT05505409

Efficacy and Safety of Pirfenidone in CTD-ILD

A Phase 4 study testing Pirfenidone and glucocorticoid and immunosuppressant 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 The sponsor has not verified this record for over two years, so it may be out of date.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 single-center randomized controlled study will be used to observe the efficacy and safety of pirfenidone on CTD-ILD patients for 24 months. The main research endpoints is the lung function (FVC) at 6 months. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pirfenidone and glucocorticoid and immunosuppressant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
22 Jun 2022to 1 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 1. Subjects have systemic vasculitis, other arthritis other than CTD or RA such AS psoriatic arthritis, SPA, AS, SLE and pSS;
  • 2. ILD patients with other obvious causes, such as HIV, GVHD, etc.
  • 3. Patients with obvious abnormal combined organ function;
  • Liver :AST, ALT, R-GT, bilirubin at 1.5 ULN, or previously diagnosed viral hepatitis;
  • Kidney: creatinine clearance rate 30ml /min;
  • Lung: airway obstruction (pre-bronchodilator FEV1/FVC \& LT; 0.7), pleural effusion accounted for more than 20% of pleural effusion, severe pulmonary infection or other clinically significant pulmonary abnormalities;
Show all 16Show fewer
  • Cardiovascular: myocardial infarction within 6 months;
  • gastrointestinal tract: active peptic ulcer or bleeding;
  • Blood system: severe anemia, leukopenia, thrombocytopenia;
  • Nervous system: patients with mental disorders; Cerebral thrombotic events (stroke and transient ischemic attack) within the last 1 year;
  • 4. Tuberculosis, cancer, hereditary diseases and other diseases with poor prognosis;
  • 5. Effective contraception cannot be guaranteed during pregnancy, lactation or childbearing age;
  • 6. Evidence of alcohol or drug abuse, according to the researchers;
  • 7. Allergic to glucocorticoids, immunosuppressants and PFD;
  • 8. Unable to complete regular follow-up and post-treatment pulmonary function tests;
  • 9. PFD users not included in the efficacy analysis but included in the safety analysis: those who had used PFD for less than 3 months 6 months before the primary endpoint; The duration of use was less than 3 months before the 24th month of the syudy and the total duration of use was less than 6 months.

Trial locations and contacts

1 site in 1 country.

Qiang Shu, Dr contact

0086-0531-82169654

shuqiang@sdu.edu.cn

keke xie contact

0086-0531-82169654

695052518@qq.com

China1 site, 1 recruiting

  • Qilu Hospital

    Jinan, Shandong, 250012

    xiaoyun yang, +8653182169035, qlyykyc@163.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy, Safety, Immune Function of Pirfenidone in the Treatment of Connetive Tissue Disease -Related Interstitial Lung Disease(CTD-LID)

A single-center randomized controlled study will be used to observe the efficacy and safety of pirfenidone on CTD-ILD patients for 24 months.

The main research endpoints is the lung function (FVC) at 6 months. The clinical dyspnea score, 6-minute walking distance, index of lung function and imaging indicators are evaluated, as well as primary disease activity and adverse reactions of therapy with glucocorticoid and immunosuppressants up to 24 months.

Read the detailed description

A total of 120 Chinese patients with connective tissue disease-associated interstitial lung disease (CTD-ILD), including inflammatory myopathy (IIM), rheumatoid arthritis (RA), systemic sclerosis (SSc), and other connective tissue diseases, will be enrolled to use Pirfenidone or not in this study according to 2:1 random entry. Glucocorticoid and immunosuppressants worked as background treatment.

The main research endpoint is the lung function (FVC) at 6 months. The clinical dyspnea score, 6-minute walking distance, lung function and imaging indicators, primary disease activity index are evaluated regularly until 24 months. The relationship of pirfenidone concentration, clinical effect and safety, immune function will be analyzed also.

Being tested
Pirfenidone, glucocorticoid and immunosuppressant
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

    Also called glucocorticoid and immunosuppressant

    Drug:pirfenidone CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease

  • glucocorticoid and immunosuppressantDrug

    Drug: glucocorticoid and immunosuppressant CTD-ILD patients treated with glucocorticoid and immunosuppressant according to the condition of the disease

Study groups in NCT05505409
Study groupRoleWhat they receive
pirfenidone groupExperimentalCTD-ILD patients treated with pirfenidone、glucocorticoid and immunosuppressant.
Receives: Drug: Pirfenidone; Drug: glucocorticoid and immunosuppressant
No-pirfenidone groupActive comparatorCTD-ILD patients treated with glucocorticoid and immunosuppressant,without pirfebidone
Receives: Drug: glucocorticoid and immunosuppressant

What is being measured

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

  1. Change in FVC%

    change in percentage of forced vital capacity (FVC) from 6 months to baseline

    Measured: 6 months

Secondary outcomes (18)

  1. Change in FVC %

    change from baseline in percentage of forced vital capacity (FVC)

    Measured: 3months 12 months 24 months

  2. change in FEV1%、DLco%、TLC%

    change from baseline in carbon monoxide diffusing capacity (DLco)、FEV1、TLC

    Measured: 3months 6months 12months 24months

  3. Proportion of patients and time with a decrease in DLco%

    Percentage of patients and time with DLco% decreased>15% compared to baseline

    Measured: 3months 6months 12months 24months

  4. Proportion of patients and time with a decrease in FVC%

    Percentage of patients and time with FVC% decreased>10% compared to baseline

    Measured: 3months 6months 12months 24months

  5. Progression-free survival

    survival with a predicated absolute FVC% decrease of no more than 10% from baseline,and a predicated absolute DLco% decrease of no more than 15% from baseline

    Measured: up to 24months

  6. change in absolute value of FVC and DLco

    absolute value change of FVC(ml) and DLco(ml) at each time point and annual decline rate compared with baseline

    Measured: 3months 6months 12months 24months

  7. changes from baseline in 6 minutes walking distance

    changes from baseline in 6 minutes walking distance

    Measured: 3months 6months 12months 24months

  8. change in pulse oxygen saturation

    the worst oxygen saturation as measured by pulse oxygen saturation(SpO2) was observed during 6 minutes walking distance

    Measured: up to 24months

  9. Worsening respiratory symptoms

    Proportion of patients with worsening respiratory symptoms at each time point compared with baseline

    Measured: 3 months 6months 12months 24months

  10. Advances in imaging

    The proportion of patients with disease progression on imaging at each time point compared with baseline

    Measured: 3 months 6months 12months 24months

  11. Imaging changes

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

    Measured: 6months 12months 24months

  12. Borg dyspnea Index score

    cChange of Borg dyspnea index score at each time point compared with baseline

    Measured: 3 months 6months 12months 24months

  13. clinical deteriorration

    The time and incidence of the first clinical deterioration ,Number of clinical exacerbations,Time between the all-cause deaths

    Measured: up to 24months

  14. Changes from baseline in C-reactive protein (CRP),Erythrocyte Sedimentation Rate(ESR),Inflammatory factors and indicators.

    Changes from baseline in C-reactive protein (CRP),Erythrocyte Sedimentation Rate(ESR),Inflammatory factors and indicators.

    Measured: 3 months 6months 12months 24months

  15. Changes from baseline in primary disease activity

    Changes from baseline in primary disease activity

    Measured: up to 24months

  16. Adverse events , timing,type,extent,frequency,and outcome of SAE

    Adverse events , timing,type,extent,frequency,and outcome of SAE

    Measured: up to 24months

  17. FVC% area under the curve

    forced vital capacity (FVC)% area under the curve

    Measured: 3months 6months 12months 24months

  18. Predicators of pirfenidone response in each disease subgroup

    Predicators of pirfenidone response in each disease subgroup

    Measured: 3months 6months 12months 24months

Timeline

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

  1. First posted17 Aug 2022
  2. Study start22 Jun 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion1 Dec 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505409
Sponsor's protocol ID
PFD-CTD-ILD QiluH
Status last verified
Nov 2022
First submitted
16 Aug 2022
Last updated
30 Nov 2022
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 glucocorticoid and immunosuppressant 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 0 inclusion and 16 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 30 Nov 2022. 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?

Contact Qiang Shu, Dr (0086-0531-82169654, shuqiang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FVC% (time frame: 6 months). 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 NCT05505409.

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 30 Nov 2022.

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