CTRI/2024/05/067540招募中2 期
A randomized controlled trial to compare the efficacy of Tofacitinib with mycophenolate mofetil in patients with Systemic Sclerosis -interstitial Lung disease - INSIST-II
Post Graduate Institute of Medical Education and Research Chandigarh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
- •The study recruits individuals aged 18-60, diagnosed with Systemic Sclerosis (SSc) or related disorders, having SSc for =10 years and an FVC of 40-80%. Participants must show HRCT evidence of ILD and have previously received, but not recently, immunosuppressants like cyclophosphamide or rituximab. They should be on maintenance immunosuppression and exhibit progressive lung function decline.
排除标准
- •Exclusion criteria include recent tobacco use, significant chest X-ray or HRCT abnormalities besides ILD, recent immunosuppression with MMF or cyclophosphamide, prednisolone = 10 mg/day, persistent leukopenia or thrombocytopenia, pregnancy, severe pulmonary hypertension, major airflow obstruction, planned major surgery, active infection, myositis, serious comorbidities, allergies to study drugs, hepatitis B/C positivity, high serum creatinine or liver enzymes, and a history of thrombotic events.
研究者
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