The Efficacy and Safety of Corticosteroid Combining Noncorticosteroid Systemic Immunomodulatory Therapy in VKH
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants achieving corticosteroid-sparing effect
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).
详细描述
Vogt Koyanagi Harada disease (VKH) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. VKH patients given prednisone monotherapy are prone to relapse.
Noncorticosteroid systemic immunomodulatory therapy (NCSIT) demonstrated inflammation control and steroid-sparing effect in autoimmune diseases. Methotrexate as an antifolate metabolite has been widely used for its anti-inflammatory and immunomodulating properties. Adalimumab, humanized monoclonal anti-TNF-α antibody, have demonstrated the efficacy of noninfectious uveitis. Several randomized controlled trials have proved the efficacy and safety of NCSIT such as antimetabolite and biologics in non-infectious uveitis, while the optimal dose and treatment course remain unknown.
The investigators propose to explore the effect, safety and optimal dose of prednisone combining NCSIT in the treatment of VKH.
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
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis is based on Revised International Diagnostic Criteria (Read et al. 2001b).
- •Age from 12 to 70 years old.
- •Patients have no contraindication of prednisone and immunosuppressive therapy, as determined by the investigator based on the results of laboratory and physical examinations.
- •Written informed consent is provided.
排除标准
- •Patients with other ocular diseases or fundus diseases: diabetic retinopathy, neovascular/wet age-related macular degeneration
- •History of renal or hepatic insufficiency, heart failure, systemic inflammatory disease or any other condition that, in the opinion of the investigator, would put the patients at risk by participating in the protocol.
- •History of infectious disease like chronic or active hepatitis B infection, HIV infection, immunodeficiency syndrome, chronic recurring infections, or active tuberculosis.
- •Female patients who were pregnant or considering becoming pregnant during the study.
研究组 & 干预措施
Corticosteroid + NCSIT group
Patients in corticosteroid + NCSIT group will receive systemic corticosteroids combined with Methotrexate or Adalimumab or other noncorticosteroid systemic immunomodulatory such as cyclophosphamide.
干预措施: noncorticosteroid systemic immunomodulatory therapy (NCSIT) (Drug)
结局指标
主要结局
Number of participants achieving corticosteroid-sparing effect
时间窗: 6 months
Corticosteroid-sparing effect is defined by the following: (1) less than or equal to 0.5+ anterior chamber cells, less than or equal to 0.5+ vitreous haze and no active retinal or choroidal lesions; (2) no more than 10 mg of oral prednisone per day; (3) all the above-mentioned description should be maintained over 1 month
次要结局
未报告次要终点
研究者
Dan Liang
Lab of ocular immunology in Zhongshan Ophthalmic Center
Sun Yat-sen University