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临床试验/NCT05889338
NCT05889338尚未招募不适用

Impact of Adalimumab Therapy on Quality of Life of Patients With Severe Psoriasis

Sohag University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
Psoriasis Area and Severity Index

研究概览

简要总结

to evaluate the impact of adalimumab therapy on quality of life in patient with severe psoriasis.

详细描述

to evaluate the impact of adalimumab therapy against methotrexate therapy on quality of life in patient with severe psoriasis and follow up after 24 week by A- Medical history age, sex, marital state, occupation, educational level and family history. dermatologic history: onset, course, duration. B- Complete dermatologic examination

C- Psoriasis Area and Severity Index (PASI) score:

The scoring involves rating the symptoms of psoriasis from none to very severe and estimating the percentage of the body that they affect.The range of absolute PASI scores is 0-72, with higher scores indicating a greater severity of psoriasis. A score of 0 indicates no psoriasis, while a score higher than 10 suggests severe psoriasis. The scoring system includes a section for intensity and another for body coverage .The score will be evaluated before treatment, at week 12 and at week 24.

D- Dermatology Life Quality Index (DLQI):

It is self-reported questionnaire . It has been translated to >110 languages. Measurement properties of the DLQI, such as validity, reliability, and responsiveness to change were reported. It is widely used in both clinical practice and research settings, including randomized controlled trials, patient registries, and national treatment and reimbursement guidelines . The study will depend on the Arabic Tunisian version of the DLQI questionnaire . DLQI consists of 10 questions related to symptoms, feelings, daily activities, leisure, work, personal relationships and the effects of treatment on daily life within the past week. Scores can range from 0 to 30, with higher scores representing worse quality of life . The questionnaire will be answered by all participant before initiation of treatment, at week 12 and at week 24 of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • .Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate.

排除标准

  • .Pregnancy or lactation. .Chronic liver or renal disease. .History of tuberculosis. .Cancer and blood disorder.

研究组 & 干预措施

Case: adults with severe psoriasis treated by adalimumab therapy.

Active Comparator

干预措施: adalimumab and methotrexate (Drug)

Control: adults with severe psoriasis treated by methotrexate therapy.

Active Comparator

干预措施: adalimumab and methotrexate (Drug)

结局指标

主要结局

Psoriasis Area and Severity Index

时间窗: 6 month

The scoring involves rating the symptoms of psoriasis from none to very severe and estimating the percentage of the body that they affect.The range of absolute PASI scores is 0-72, with higher scores indicating a greater severity of psoriasis. A score of 0 indicates no psoriasis, while a score higher than 10 suggests severe psoriasis. The scoring system includes a section for intensity and another for body coverage .

次要结局

  • Dermatology Life Quality Index(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Fawzy Abdelhalim

Dermatology resident at Gehina Hospital

Sohag University

研究点 (1)

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