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临床试验/NCT05683626
NCT05683626招募中不适用

Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
BCVA

研究概览

简要总结

the goal of this prospective cohort study is to asses the Safety and efficacy of Adalimumab therapy for treatment of Behcet's disease-related uveitis in adult patients at sohag university hospital.

Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.

详细描述

Study design: Prospective cohort study. Sample size: 40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study.

  1. Inclusion Criteria:

Adult patients with complete Behçet's disease associated uveitis . BD was diagnosed according to the classification criteria for BD proposed by the International Study Group for Behçet Disease . 2. Exclusion Criteria:

Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study 3. Treatment plan:

Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with complete Behçet's disease associated uveitis .

排除标准

  • Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study

结局指标

主要结局

BCVA

时间窗: 1 year

best corrected visual acuity

次要结局

  • vitreous haze(1 year)
  • AC cells(1 year)

研究者

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

Mervat Zidan Mahmoud

assistant lecturer

Sohag University

研究点 (1)

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