Phase III Study of Recombinant Human Interferon-alpha2a Versus Cyclosporin A for the Treatment of Ocular Behcet's Disease - a National,Randomised, Single-masked Controlled Trial (INCYTOB)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)
研究概览
简要总结
The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet's disease.
详细描述
Behcet's disease is a multisystem vasculitis often involving ocular (retinal) blood vessels (in 70% of all cases). This form of uveitis or retinal vasculitis still leads to blindness in 25 to 50% of the patients irrespective of immunosuppressive treatment.
The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment (cyclosporin A (CSA)) for severe ocular (panuveitis, posterior uveitis, retinal vasculitis) Behçet's Disease (BD) and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment. Furthermore, we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment.
The patients are randomised into two treatment groups (IFN/CSA) and treated for one year according to an algorithm which adapts dosages to clinical course. A crossover from one treatment arm to the other is planned in case of inefficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Behçet's disease fulfilling the International Study Group Criteria with active pan- or posterior uveitis (according to the posterior uveitis scoring system) or retinal vasculitis and active disease according to the Behcet's Disease activity scoring system.
排除标准
- •Previous treatment with interferon-α or cyclosporin A
- •Pregnancy, breast feeding women, malignancy
- •Renal impairment (creatinine > 1.5 mg/dl)
- •Uncontrolled hypertension or diabetes
- •Depression or other psychic disorders(also history of depression)
- •History of acute or chronic inflammatory joint or autoimmune disease
- •Organ or bone marrow transplant recipient, cardiac failure > NYHAIII
- •Acute liver disease with SGPT 2x above normal
- •White blood cell count < 3500/mm3
- •Platelet count < 100000/mm3
- •Hgb < 8.5g/dl
- •Body weight <45 kg
- •Alcohol abuse or drug abuse
- •Mental impairment
- •Uncooperative attitude
研究组 & 干预措施
A Cyclosporin A
Cyclosporin A
干预措施: Cyclosporin A (Drug)
B Interferon alpha
Interferon-alpha2a
干预措施: Interferon-alpha2a (Drug)
结局指标
主要结局
Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)
时间窗: 2 years
Time to improvement and remission
时间窗: 2 years
次要结局
- Laboratory values for inflammatory activity (monthly)(2 years)
- Number of ocular and non-ocular relapses (1 year, 2 years)(2 years)
- Number of switches from one treatment to the other(2 years)
- Quality of life for patients with low vision (monthly)(2 years)
- Duration of the treatment-free period (second year)(2 years)