Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Dermatology Life Quality Index (DLQI)
研究概览
简要总结
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:
- how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa
- Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy
详细描述
The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are:
- how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa
- Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy.
Pre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role of effect modifiers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of Hidradenitis suppurativa resistant to conventional therapy
排除标准
- •Immunocompromised patients
- •Patients with connective tissue disorders
- •patients having chronic infections like heapatitis, HIV or Tuberculosis
- •Pregnant or lactating mothers
- •hypersensitivity to biologics
结局指标
主要结局
Dermatology Life Quality Index (DLQI)
时间窗: 24 weeks
50% reduction
Hidradenitis Suppurativa Clinical Response (HiSCR)
时间窗: 24 weeks
50% reduction in score
次要结局
未报告次要终点
研究者
Hira Tariq
Principal Investigator
Services Institute of Medical Sciences, Pakistan