CTRI/2016/02/006617已完成3 期
A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) - SENSCIS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
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. Written informed consent consistent with ICH-GCP guidelines and local laws signed
- •prior to entry into the trial and any trial related procedures.
- •2. Patients must fulfil the 2013 ACR / EULAR classification criteria for SSc.
- •3. SSc disease onset (defined by first non-Raynaud symptom) must be within 5 years of
- •4. SSc related Interstitial Lung Disease pattern must be confirmed by HRCT performed
- •within 12 months of Visit 2. The extent of fibrotic disease in the lung must be more than or equal to 10% on HRCT, assessed by central review.
- •5. FVC more than or equal to 40% of predicted normal at Visit 2.
- •6. DLCO (corrected for Hb [Visit 1]): 30% to 89% of predicted at Visit 2
排除标准
- •1. AST, ALT more than 1.5 x ULN.
- •2. Bilirubin more than 1.5 x ULN.
- •3. Creatinine clearance less than 30 mL/min calculated by Cockcroftâ??Gault formula
- •4. Airway obstruction (pre-bronchodilator FEV1/FVC less than 0.7) at Visit 1.
- •5. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- •6. Significant PH
- •7. Cardiovascular diseases
- •8. More than 3 digital fingertip ulcers at Visit 2 or a history of severe digital necrosis
- •requiring hospitalization.
- •9. Bleeding risk
- •10. History of thrombotic event (including stroke and transient ischemic attack) within
- •12 months of Visit 1.
- •11. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
- •12. Other disease or conditions that may interfere with testing procedures
- •13. Life expectancy of less than 2.5 years for disease other than SSc in investigator assessment.
- •14. Patients with clinical signs of malabsorption or needing parenteral nutrition
- •15. Previous treatment with nintedanib or pirfenidone.
- •16. Other investigational therapy received within 1 month or 6 half-lives (whichever was
- •greater) prior to screening Visit (Visit 1).
- •17. Treatment with
- •a. Prednisone more than 10 mg/day or equivalent received within 2 weeks prior Visit 2,
- •b. Azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine,
- •received within 8 weeks prior Visit 2,
- •c. Cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus,
- •newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium paraaminobenzoate,
- •received within 6 months prior Visit 2.
- •18. Unstable background therapy with either mycophenolate mofetil or methotrexate
- •(combined therapy of both not allowed)
- •19. Previous hematopoietic stem cell transplantation (HSCT), or HSCT planned within the
- •20. Major surgical procedures planned to occur during trial period.
- •21. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •22. Women of childbearing potential not willing or able to use highly effective methods of
- •birth control.
- •23. In the opinion of the Investigator, active alcohol or drug abuse.
- •24. Patients not able to understand or follow trial procedures including completion of selfadministered questionnaires without help.
研究者
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