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临床试验/NCT04588818
NCT04588818Unknown2 期

Adalimumab in Combination With Methotrexate for the Treatment of Non-infectious Panuveitis in Chinese Children

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
30
试验地点
1
主要终点
the time to reach the remission

研究概览

简要总结

The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis.

详细描述

Although non-infectious uveitis is rare in pediatric population, the irreversible visual impairment due to ocular complications, severe drug adverse effects are disturbing. There is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis, which result in structure destruction and functional impairment including band keratopathy, posterior synechiae, cataract, and so on. The systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events.

Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis. it was benefit to prolong remission and reduce recurrence. However, despite early intervention 27-48% children do not achieve control of inflammation and 20% experience adverse events. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis, a better visual acuity and a lower dose of dosage of daily glucocorticoid.

The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year.

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
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of non-infectious panuveitis
  • Age from 2 to 16 years old
  • Vision threatening non-infectious uveitis hadn't received standardized systematic treatment before

排除标准

  • Patients who had active infection (including hepatitis B or C infection, tuberculosis), malignancy diseases, or bilateral irreversible blindness and any other contraindications of ADA
  • previous exposure to another biologic agent

研究组 & 干预措施

Adalimumab plus Methotrexate

Experimental

干预措施: Adalimumab plus Methotrexate (Drug)

结局指标

主要结局

the time to reach the remission

时间窗: 12 months

次要结局

  • the time of a first relapse once remission(12 months)
  • the total dosage of corticosteriod or the time to steroid discontinuation(12 months)
  • macular structure(12 months)
  • Best corrected visual Acuityand(12 months)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Liang

M.D

Sun Yat-sen University

研究点 (1)

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