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临床试验/NCT06729463
NCT06729463已完成不适用

IKBKB Gene Polymorphism (Single Nucleotide Polymorphism) (SNP) in Psoriatic and Psoriatic Arthritis Patients and Its Relation With Response to Systemic Biologic Therapy

South Valley University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月1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
已完成
入组人数
50
试验地点
1
主要终点
Treatment of the Psoriasis disease

研究概览

简要总结

Psoriasis is a chronic inflammatory skin disease characterized by scaly indurated erythema. It impairs patients' quality of life enormously.

Psoriasis refers to a persistent inflammatory illness of the skin and joints. It also impacts roughly 2%-3% of the inhabitants of the universe

详细描述

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.

Psoriatic arthritis, which is characterized by dactylitis and enthesis, is closely associated with psoriasis. Up to 30-40% of patients with psoriasis will develop PsA, with an average of 10 years between psoriasis and PsA . The overlapping of genetic variations and inflammatory mediators involved in psoriasis and PsA implies a common pathogenic mechanism between the two diseases.

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.

Oral treatments include traditional agents such as methotrexate, acitretin, cyclosporine, and the advanced small molecule apremilast, which is a phosphodiesterase 4 inhibitor. Oral treatments include traditional agents such as methotrexate, acitretin, cyclosporine, and the advanced small molecule apremilast, which is a phosphodiesterase 4 inhibitor.

The American Academy of Dermatology-National Psoriasis Foundation guidelines recommend biologics as an option for first-line treatment of moderate to severe plaque psoriasis because of their efficacy in treating it and acceptable safety profiles.

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
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 16 and 60 years proved having psoriasis diagnosed clinically for at least 6 months and who have a severity grade of moderate to severe, defined as a Psoriasis Area and Severity Index (PASI) score greater than 10, and involvement of greater than 10% of the body surface area (BSA) with or without psoriatic arthritis

排除标准

  • Patient receiving immune suppressive drugs.
  • Patients having malignancy.
  • Pregnant or lactating female.
  • Patients having liver disease ( Hepatitis)
  • Patients having comorbid and/or uncontrolled renal, cardiac, vascular, and hepatic diseases or symptoms.
  • Active infection or human immunodeficiency virus (HIV)
  • Tuberculosis

研究组 & 干预措施

Group A: Humira Group

Active Comparator

About 20 patients suffering from psoriasis disease and they will take Humira vials about 40 mg every two weeks by subcutaneous injection for 3 months

干预措施: Humira (Drug)

Group B: Cosentyx Group

Active Comparator

About 20 patients suffering from severe psoriasis will take Cosentyx vials by intravenous infusion as :

1-Loading dose about(300 mg) then decreasing the dose to be 150 mg every month for 3 months.

干预措施: Humira (Drug)

Group C: control Group

Placebo Comparator

About 10 Healthy participants and will take no medical treatment

干预措施: Humira (Drug)

结局指标

主要结局

Treatment of the Psoriasis disease

时间窗: 3 months

Evaluation the clinical efficacy of biological therapy in patients of psoriasis and assessing the relation between the drug response and IKBKB mutation

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

Fatma Abdel-monem Mahmoud

Resident of Dermatology, Venereology and Andrology.

South Valley University

研究点 (1)

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