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临床试验/NCT06043752
NCT06043752已完成4 期

Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis

Ghurki Trust and Teaching Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2022年3月10日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

研究者

发起方
Ghurki Trust and Teaching Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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