Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- At least 50% reduction in PASI
研究概览
简要总结
The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:
Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?
Participants will:
be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients of moderate to severe plaque psoriasis Biologically naive patients
排除标准
- •Patients with active or latent TB, Hepatitis B or C, HIV. Immunocompromised patients due to drugs or disease. Patients on systemic anti-psoriastic medications in last three months. Patients with personal or strong family history of heart disease. Any other medical comorbidity (hepatic or renal) or contraindication to biologic/ biosimilars.
研究组 & 干预措施
Adult Patients of moderate to severe plaque psoriasis
干预措施: Infliximab-dyyb Biosimilar (Remsima) (Biological)
结局指标
主要结局
At least 50% reduction in PASI
时间窗: 14 weeks
PASI should reduce to at least 50% of baseline (pre-treatment)
At least 50% reduction in DLQI
时间窗: 14 weeks
DLQI (Dermatology Life Quality Index) should reduce to at least 50% of baseline (pre-treatment)
次要结局
- Maintenance of At least 50% reduction in PASI and DLQI(52 weeks)
研究者
Hira Tariq
Dr
Services Institute of Medical Sciences, Pakistan