The Efficacy of Anti-TNF Alpha Agents in the Treatment of JIA- Associated Uveitis in a Pediatric Cohort
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- the severity and complications of the uveitis
研究概览
简要总结
Juvenile Idiopathic Arthritis (JIA) remains the most common systemic disorder associated with pediatric uveitis. Studies estimate that 28-67% of patients with JIA-associated uveitis develop ocular complications, with 12% developing poor visual outcome. The only means of improving long term effects of uveitis, is early and aggressive anti-inflammatory treatment, including biologics.
详细描述
Juvenile Idiopathic Arthritis (JIA) remains, globally, the most common systemic disorder associated with pediatric uveitis consisting 75% of anterior uveitis cases (AU)1. In a cohort study from Cairo University Pediatric Hospital, JIA accounted for 39% of all cases of pediatric uveitis (unpublished data). Studies estimate that 28-67% of patients with JIA-U develop ocular complications, with 12% developing poor visual outcome2,3,4. Thus, early and aggressive anti-inflammatory treatment is the only means of improving long term effects of uveitis5-7.
In 2019, the American College of Rheumatology/Arthritis Foundation recommended, that in severe, active, chronic AU or in the presence of sight-threatening complications, methotrexate (MTX) and a monoclonal antibody Tumor Necrosis Factor inhibitor (TNFi) should be immediately administered8. Biologic drugs act against specific cytokines or their receptors, in order to reduce tissue damage9. Currently, infliximab, and adalimumab are the main TNF inhibitors available for children10 and are used in the treatment of refractory or chronic childhood uveitis 11,12 . Our study aims to analyze the value and outcome of using biologics at Abou el Reesh, Cairo University Hospital, being a main tertiary referral center in Egypt for children with JIA-U.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed JIA according to rheumatological criteria with ocular affection
- •Any type of arthritis (oligoarticular, polyarticular, systemic onset, ocular JIA)
- •ANA positive or negative
- •Uncontrolled uveitis or frequent relapses
排除标准
- •Patients without definitive diagnosis as JIA
- •JIA patients on biologics without ocular affection (for systemic control) or with uveitis controlled without the use of biologics
- •Patients without adequate duration for follow-up (less than 3 months) or lost follow up data
- •Patients without available data prior to the start biologics (to compare control of the uveitis)
研究组 & 干预措施
JIA associated uveitis
patients diagnosed with Juvenile idiopathic arthritis and uveitis taking immunosuppression including biologics 9of any type according to their rheumatologist recommendations) for control of their autoimmune uveitis.
干预措施: biologic DMARDs (Drug)
结局指标
主要结局
the severity and complications of the uveitis
时间窗: 24 months
degree of clinical improvement by clinical examination
steroids sparing effect of the drug
时间窗: 24 months
reduction in the dosage/frequency of topical and systemic steroids
次要结局
未报告次要终点
研究者
Mai Nasser Abd Elmohsen
lecturer of ophthalmology
Kasr El Aini Hospital