CTRI/2019/01/017157尚未招募不适用
Randomized controlled trial to compare the efficacy and safety of Rituximab infusion with systemic steroids versus only systemic steroids in Pemphigus group of disorder
GMERS Medical College and Hospital Sola1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- we will evaluate for cumulative dose of systemic steroids & time require to reach minimum dose (10 mg prednisolone daily) in each patients after 4 months
研究概览
简要总结
Pemphigus is a rare, life-threatening autoimmune disease. If not treated well it ends up with fatality. Systemic corticosteroids alone has to give for longer periods , which is associated with many adverse effect & some patients show poor response to it. So I will conduct this study to prove better impact of rituximab compare toconventional treatment which decreases need for steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of above 18 years and of any gender , who willing to sign written informed consent.
排除标准
- •Any patient with active bacterial, viral, invasive fungal infections.
- •HIV reactive patients.
- •Any haematological dyscrasia/ Bleeding tendency.
- •Patients with history of any severe drug reaction in past.
- •Patients with metabolic disturbances, cardiac disorders.
- •Pregnancy and lactation.
- •Patients or relatives – not willing to sign written informed consent.
结局指标
主要结局
we will evaluate for cumulative dose of systemic steroids & time require to reach minimum dose (10 mg prednisolone daily) in each patients after 4 months
时间窗: Patients will be followed up: Weekly for 1 month Fortnightly for 4 months
次要结局
- study any side effects in both groups.(From initiation of treatment to 4 months)
研究者
研究点 (1)
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