A randomized controlled trial to compare the efficacy of pirfenidone with placebo in systemic sclerosis related interstitial lung disease

Post graduate institute of medical education and research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Patients with SSc as diagnosed by the American College of
•Rheumatology (ACR) criteria, 2013 & patients with other connective tissue diseases
•who, in parallel, meet the ACR criteria for SSc
•2. Presence of ILD on HRCT chest
•3. FVC >= 50%
•4. Duration of SSc for <=7 years, with onset defined as the appearance of the first nonRaynaudâ??s
•phenomenon.
•5. DLCO 30% to 89% of predicted normal
•6. Consenting for participating in study
•7. Received no new immunosuppression for last 6 months (on stable doses of
•immunosuppressants like azathioprine, MMF, cyclophosphamide, methotrexate for > 6

•Change in immunosuppressant drugs (except low dose steroids i.e. prednisolone
•equivalent <=10 mg/day) for ILD in the previous 6 months.
•2. Received biologics in the past
•3. Persistent leukopenia or thrombocytopenia
•4. Pregnant or breastfeeding females
•5. Severe PAH (mean pulmonary arterial pressure >55mmHg) requiring drug therapy
•6. FEV1/FVC ratio <=65%
•7. Uncontrolled congestive heart failure
•8. Any other abnormalities noted on chest X-ray or HRCT other than ILD
•9. Active infection
•10. Inflammatory myopathy
•11. Mixed connective tissue disease
•12. Smoking during last 6 months
•13. Other serious co-morbidities which could compromise the patientâ??s ability to complete
•14. Abnormal liver function tests (AST/ALT > 3times, bilirubin >1.5)

发起方

Post graduate institute of medical education and research