IRCT2016022126686N1招募中3 期
Evaluation the clinical trial of Rituximab (Zytux) efficacy in improving the skin stiffness and lung involvements of the patients with diffuse cutaneous Systemic sclerosis with diffuse skin involvement
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
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
- 年龄范围
- no limit 至 no limit（—）
- 性别
- All
入选标准
- •Inclusion Criteria: age more than 20 year old; patients with diffuse cutaneous Systemic sclerosis (SSc) with disease duration less than 7 years from the Raynaud's phenomen; modified Rodnan skin score (mRSS) more than 20; the presence of interstitial lung disease (ILD) in high resolution computed tomography (HRCT) or pulmonary function test (PFT) or both (if the ILD involvement is more than 20% it will be sufficient and in the other situation the ILD should be proved by HRCT and PFT); the mRSS should be remained unchanged after 6 months of the treatment with Endoxan or Cellcept as the previous therapy.
排除标准
- •the previous history of Rituximab administration; the history of nervous system disorders like Multiple sclerosis; the history of viral hepatitis like Hepatitis B or C; the history of human immunodeficiency virus infection; the history of tuberculosis infection with PPD more than 5 millimeter; the history of malignancy; dyspnea at rest; the sign and symptoms of congestive heart failure at rest; the history of infectious diseases; the history of cardiac arhythmia on electrocardiogram; the history of prednisolone usage more than 10 mg per day; tricuspid regurgitation jet flow velocity more than 2.8; pulmonary arterial pressure more than 35 according to trans-thoracic ecocardiography; ejection fraction less than 40%; diffusion capacity of the lung for carbon monoxide less than 50%; forced vital capacity less than 50%; serum creatinine level more than 1.5; the history of scleroderma renal crisis; the history of co-morbid cardiac, pulmonary and renal diseases unrelated to SSc.
研究者
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