Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital
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.
- 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
- 否
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
Mervat Zidan Mahmoud
assistant lecturer
Sohag University
