Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Psoriasis Area Severity Index Score
研究概览
简要总结
Psoriasis is a persistent condition which demands prolonged management, so it puts heavy financial as well as psychological burden on patients. Severe psoriasis makes work impossible for patients. If it affects exposed parts of the body, it may lead to decrease in self-esteem, social avoidance, and shame. Patients with even mild form of psoriasis have high stigma as compared to other cutaneous diseases. As a result, psoriasis affected individuals experience greater difficulty in social interactions and employment. Patients experience symptoms in psoriasis includes bleeding, itching and inflamed joints. Psoriatic patients develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in these individuals. Moreover, early age onset of psoriasis leads to more physical impairment. Hence, patients get trapped in a vicious cycle as stress leads to further aggravation of disease. The European Medicine Agency has given its approval regarding the usage of INFLIXIMAB bio similar REMSIMA for psoriasis after taking in consideration its effectiveness from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. This study is being conducted as no data is present on REMSIMA SC in psoriasis patient in Pakistan.
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 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-59 years
- •Both genders
- •Diagnosed patient of Psoriasis
- •Moderate to severe psoriasis
- •Not responding to topical treatment
- •Not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy.
- •PASI score >10.
排除标准
- •Patient with active systemic lupus erythematosus or ANA positive patients.
- •Patient with active tuberculosis.
- •Extremely immunocompromised patient.
- •Patient with cardiac disease.
- •Patient with allergic reaction to REMSIMA.
- •Pregnancy and Lactation.
研究组 & 干预措施
Remsima
干预措施: Remsima (Drug)
结局指标
主要结局
Psoriasis Area Severity Index Score
时间窗: 24 weeks
Patients will be followed 4,8,14 and 24 weeks
Adverse Events
时间窗: 24 weeks
Patients will be followed 4,8,14 and 24 weeks
次要结局
未报告次要终点
