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临床试验/NCT06870500
NCT06870500招募中不适用

Card14gene (rs34367357 ) Polymorphism in Egyptian Psoriatic and Psoriatic Arthritis Patient and Its Relation With Response to Methotrexate

South Valley University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Psoriasis Treatment

研究概览

简要总结

Psoriasis is a chronic, immune-mediated, multisystemic, inflammatory disease caused by the interaction of multiple susceptibility genes and environmental factors that affects 1-3% of the population worldwide .Psoriasis also is a chronic inflammatory skin disease characterized by scaly indurated erythema.

Psoriatic arthritis (PsA) is an autoimmune and chronic musculoskeletal disorder that is associated with psoriasis of the skin . Its presentation can vary from subtle manifestations to highly destructive forms. Joint pain, stiffness and swelling are the most common symptoms.

详细描述

PsA is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients .

The exact aetiopathogenesis of psoriasis is not completely explained. Pathological mechanism involves skin inflammation and hyperproliferation of keratinocytes induced innate and adaptive immune cells. Genetic, immunological and environmental factors are considered the most important aetiologies.

Psoriasis is a chronic relapsing disease, which often necessitates a long-term therapy. Mild to moderate psoriasis can be treated topically with a combination of glucocorticoids, vitamin D analogues, and phototherapy. Moderate to severe psoriasis often requires systemic treatment. The presence of comorbidities such as psoriasis arthritis is also highly relevant in treatment selection.

Methotrexate (MTX) has remained the backbone of the treatment for moderate to severe psoriasis ever since its first use nearly half a century ago.

Over the years, its high efficacy, low cost, relative ease of administration and usefulness in concomitant psoriatic arthritis have contributed in making MTX the drug of choice in managing severe psoriasis. Although the majority of patients achieve remission of disease activity with MTX, a significant proportion may experience mild and transient adverse effects. From time to time, various guidelines on the use of MTX have correctly and adequately stressed the need for strict monitoring of haematological and hepatic adverse events.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and above.
  • Patients having psoriasis diagnosed clinically and who have a severity grade of moderate to severe, defined as a Psoriasis Area and Severity Index (PASI) score from 5- 10 % of body surface area, and involvement of greater than 10% of the body surface area (BSA) with or without psoriatic arthritis

排除标准

  • Patients with other autoimmune conditions (e.g., rheumatoid arthritis, systemic lupus erythematosus).
  • Pregnancy and lactation.
  • Patients currently undergoing immunosuppressive or systemic therapies.
  • Patients with known genetic disorders affect immune system function.
  • Patients with liver or kidney impairment.
  • Patients with allergy or contraindication to methotrexate.
  • Patients with active or uncontrolled infections, including chronic infections like tuberculosis.

研究组 & 干预措施

Group B

Active Comparator

About 20 psoriatic arthritis

干预措施: Methotrexate (Drug)

Group C

Placebo Comparator

About 10 healthy control group

干预措施: Placebo (Drug)

Group A

Active Comparator

About 20 patients with psoriasis

干预措施: Methotrexate (Drug)

结局指标

主要结局

Psoriasis Treatment

时间窗: 3 Months

Assessing the Response of psoriasis and psoriatic arthritis to Methotrexate by assessment and complete cutaneous examination to evaluate the clinical type and severity of psoriasis using PASI score

次要结局

未报告次要终点

研究者

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

Marwa Naguib Ahmed

Resident of Dermatology , venereology and andrology at Faculty of medicine

South Valley University

研究点 (1)

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