The Efficacy and Safety of Adalimumab for Inflammatory Flare Prevention in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage Compared With Methotrexate, a RCT Study
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Uveitis flare
研究概览
简要总结
Children with anterior uveitis are prone to suffer from chronic recurrent course of intraocular inflammation and adverse effects of glucocorticosteroids (GCs) /immunomodulatory treatment (IMT) agents. The performance of adalimumab has been shown to be fairly favorable in treating refractory non-infectious uveitis. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious anterior pediatric uveitis with peripheral vascular leakage compared with methotrexate. Children weighed ≥ 30kg and aged between 4-16 years old with active chronic non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra wildfield fluorescence fundus angiography (UWFFA) will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either MTX or adalimumab and regularly followed up for at least 6 months. The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1. Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.
详细描述
This is a prospective, single-center, interventional, randomized, non-blinded, controlled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital.
Children with active noninfectious anterior uveitis demonstrating peripheral vascular leakage on UWFFA and meet the selection criteria will be randomly assigned to treatment group or control group.
Both groups will be treated with a predesigned plan for the active inflammation. At one month or when patients' ocular inflammation gets controlled to 0.5+ cell in the anterior chamber, whichever comes later, patients in the treatment group will be given adalimumab subcutaneously at 40mg every 2 weeks, patients in the control group will be given methotrexate10mg orally once a week.
Follow-up visits will be scheduled every two weeks at the run-in period and the first month after randomization, and every month from the second to the sixth month.
The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with noninfectious uveitis aged between 4-16, weight ≥ 30kg.
- •Uveitis resistant to well conducted topical steroid therapy for three months, or uveitis resistant to well conducted 0.1% prednisolone twice a day for one month
- •Retina peripheral vascular leakage demonstrated by UWFFA at the time of inclusion.
排除标准
- •Any contraindication to administration of immunosuppressive therapy (active tuberculosis, immune deficit, opportunistic infection, other severe chronic disease).
- •Previous diagnosis or signs of demyelinating disease of the central nervous system.
- •Children unable to cooperate with examinations and follow-up.
- •Positive allergy skin test when conducting fluorescence fundus angiography.
- •Diffuse vascular leakage, macula edema or any retina lesions demonstrated by UWFFA.
- •History of oral immunosuppressive drug treatment within 2 months
- •History of biological treatment within 2 months
- •History of triamcinolone acetonide subconjunctival/intraocular injection within 3 months
- •Current topical steroid use more than six times per day
- •History of eye surgery within 3 months.
- •Eye complications that interfere with fundus observation.
研究组 & 干预措施
Adalimumab
Adalimumab administered subcutaneously at 40mg every 2 weeks
干预措施: Adalimumab (Drug)
Methotrexate
Methotrexate given 10mg orally once a week.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Uveitis flare
时间窗: At 6 months' follow-up visit
Uveitis flare is defined as anterior chamber cell count grading increased from 0 to 1. The grading method is in accordance with SUN criteria. Anterior chamber cell count was scored according to Standardization of Uveitis Nomenclature (SUN) criteria
次要结局
- Vitreous haze(At 6 months' follow-up visit)
- Best corrected visual acuity (BCVA)(At 6 months' follow-up visit)
- frequency of topical steroid eyedrops if any inflammatory flare happens.(At 6 months' follow-up visit)
- Systemic immunomodulatory therapy (sIMT, including GCs and immunosuppressive drugs)load at the 6-month follow-up visit if any inflammatory flare ever happens.(At 6 months' follow-up visit)
- Keratic precipitates(At 6 months' follow-up visit)
- Extent of peripheral vascular leakage(At 6 months' follow-up visit)
- Adverse events(through study completion, an average of 6 months)