CTRI/2021/11/037864招募中未知
A RANDOMIZED CONTROLLED TRIAL TO COMPARE THE EFFICACY OF ORAL TACROLIMUS WITH ORAL MYCOPHENOLATE MOFETIL IN PATIENTS WITH SYSTEMIC SCLEROSIS - INTERSTITIAL LUNG DISEASE - INSIST
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 1. Age 18-75 years
- •2. Patients with SSc as diagnosed by the American College of
- •Rheumatology (ACR) criteria, 2013 and patients with other connective tissue diseases who, in parallel, meet the ACR criteria for SSc (overlap syndromes except inflammatory myopathy)
- •3. Duration of SSc for ââ?°Â¤7 years, with onset defined as the appearance of the first non-Raynaudââ?¬•s symptom
- •4. Consenting for participating in study
- •5. FVC - 40-80%
- •6. DLco- 30-80% of normal
- •7. HRCT chest suggestive of ILD ( >10% of lung parenchyma)
- •8. May have received immunosuppression CYC (ââ?°Â¥6 doses of IV or oral for 6 months) or MMF (ââ?°Â¥6months) previously but at least >6 months prior to randomization, and still have progressive declining lung function indicated by change of 10% in FVC and 15% in DLCO
- •9. On maintenance immunosuppression with azathioprine, low dose steroids (ââ?°Â¤10mg/day), but having progressive declining lung function
排除标准
- •1. FVC <40%
- •2. DLco <30%
- •3. Serum creatinine ââ?°Â¥1.2mg/dl
- •4. Smoking tobacco in last 6 months
- •5. Clinically significant abnormality on chest-x-ray other than ILD (e.g- lung mass, effusion)
- •6. Immunosuppression- MMF or cyclophosphamide in last 30 days
- •7. Prednisolone ââ?°Â¥10mg/day
- •8. Persistent leucopenia( <4000/mm3) or thrombocytopenia ( <100,000/mm3)
- •9. Pregnant or breastfeeding females
- •10. Severe pulmonary arterial hypertension (mean pulmonary arterial pressure >55mmHg) requiring drug therapy
- •11. Significant airflow obstruction (pre-bronchodilator FEV1/FVC ââ?°Â¤0.65%)
- •12. Known hypersensitivity to the trial medication or its components
- •13. Life expectancy of <3 years for disease other than the underlying CTD in investigator assessment
- •14. Uncontrolled congestive heart failure
- •15. Uncontrolled hypertension
- •16. Major surgical procedures planned to occur during trial period
- •17. Any other abnormalities noted on chest X-ray or HRCT other than ILD
- •18. Active infection
- •19. Active myositis
- •20. Known seizure disorder
- •21. Other serious co-morbidities which could compromise the patientââ?¬•s ability to complete the study
- •22. Allergy/hypersensitivity to medication or its constituents
研究者
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