Efficacy, Safety, Immune Function of Pirfenidone in the Treatment of Connetive Tissue Disease -Related Interstitial Lung Disease(CTD-LID)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in FVC%
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects have systemic vasculitis, other arthritis other than CTD or RA such AS psoriatic arthritis, SPA, AS, SLE and pSS;
- •ILD patients with other obvious causes, such as HIV, GVHD, etc.
- •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;
- •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;
- •Tuberculosis, cancer, hereditary diseases and other diseases with poor prognosis;
- •Effective contraception cannot be guaranteed during pregnancy, lactation or childbearing age;
- •Evidence of alcohol or drug abuse, according to the researchers;
- •Allergic to glucocorticoids, immunosuppressants and PFD;
- •Unable to complete regular follow-up and post-treatment pulmonary function tests;
- •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.
研究组 & 干预措施
pirfenidone group
CTD-ILD patients treated with pirfenidone、glucocorticoid and immunosuppressant.
干预措施: Pirfenidone (Drug)
pirfenidone group
CTD-ILD patients treated with pirfenidone、glucocorticoid and immunosuppressant.
干预措施: glucocorticoid and immunosuppressant (Drug)
No-pirfenidone group
CTD-ILD patients treated with glucocorticoid and immunosuppressant,without pirfebidone
干预措施: glucocorticoid and immunosuppressant (Drug)
结局指标
主要结局
Change in FVC%
时间窗: 6 months
change in percentage of forced vital capacity (FVC) from 6 months to baseline
次要结局
- Advances in imaging(3 months 6months 12months 24months)
- Proportion of patients and time with a decrease in FVC%(3months 6months 12months 24months)
- changes from baseline in 6 minutes walking distance(3months 6months 12months 24months)
- change in pulse oxygen saturation(up to 24months)
- Imaging changes(6months 12months 24months)
- Proportion of patients and time with a decrease in DLco%(3months 6months 12months 24months)
- Progression-free survival(up to 24months)
- clinical deteriorration(up to 24months)
- Changes from baseline in C-reactive protein (CRP),Erythrocyte Sedimentation Rate(ESR),Inflammatory factors and indicators.(3 months 6months 12months 24months)
- change in FEV1%、DLco%、TLC%(3months 6months 12months 24months)
- change in absolute value of FVC and DLco(3months 6months 12months 24months)
- Predicators of pirfenidone response in each disease subgroup(3months 6months 12months 24months)
- Change in FVC %(3months 12 months 24 months)
- Worsening respiratory symptoms(3 months 6months 12months 24months)
- Borg dyspnea Index score(3 months 6months 12months 24months)
- Adverse events , timing,type,extent,frequency,and outcome of SAE(up to 24months)
- FVC% area under the curve(3months 6months 12months 24months)
- Changes from baseline in primary disease activity(up to 24months)
研究者
Qiang Shu
Principal Investigator
Qilu Hospital of Shandong University