Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- forced vital capacity
研究概览
简要总结
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test
详细描述
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
participant and outcome assrssor
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •active ILD scleroderma
排除标准
- •abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
研究组 & 干预措施
Rituxmab
1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
干预措施: Rituximab (Drug)
IL-6 inhibitor
6 mg/kg IV infusion every month not exceed 600 mg for 1 year
干预措施: IL6 inhibitor (Drug)
结局指标
主要结局
forced vital capacity
时间窗: 6 months
pulmonary function test
次要结局
- computed tomography chest(1 year)
- modified rodnan skin score(6 months)
研究者
Manal Hassanien
Associate Professor
Assiut University