Treatment of Graves´Ophthalmopathy With Simvastatin (GO-S)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Clinical activity score (CAS) after 6 months
研究概览
简要总结
In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.
详细描述
Progression of GO from mild-moderate to severe disease:
Criteria for start of treatment with corticosteroids, retrobulbar irradiation, or orbital decompression are severe soft tissue swelling (NO SPECS class 2c), risk of corneal ulcers with or without exophthalmos, double vision within 30 degrees, and optic nerve dysfunction. Patients who progress will be followed until the end of the study with the ongoing randomized treatment.
Withdrawal criteria:
- Patients may withdraw from the trial at any time without any consequences for their future treatment.
- Patients may be withdrawn from the trial at the discretion of the investigator if judged to be non-compliant with trial procedures or due to safety concerns.
- Patients must be withdrawn from the trial if they become pregnant or develop congestive heart failure, renal insufficiency, coagulopathy, gastric ulcer, inflammatory bowel disease, diabetic retinopathy, diabetic nephropathy, severe myopathy, or rhabdomyolysis.
Laboratory investigations before randomization:
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of <18 months (as recorded by the patient)
- •Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid after total thyroidectomy. Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval and no clinical symptoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.
排除标准
- •Pregnancy or breast-feeding
- •Previous treatment of Graves´ ophthalmopathy
- •Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
- •Current or previous treatment with simvastatin or other statins (within 3 months)
- •Allergy (skin rash or systemic reactions) to statins
- •Congestive heart failure
- •Renal insufficiency (glomerular filtration rate <60 ml/min)
- •ASAT or ALAT > 2.5 times the upper limit of the local laboratory
- •Alcoholism as judged by local criteria
- •Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
- •Previous or current gastric ulcer
- •Inflammatory bowel disease diabetic retinopathy or nephropathy
- •Trauma within 10 days
研究组 & 干预措施
Simvastatin
simvastatin 40 mg daily for 6 months
干预措施: Simvastatin 40mg (Drug)
结局指标
主要结局
Change in Clinical activity score (CAS) after 6 months
时间窗: 6 months
Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment
Number of patients with progression to severe GO during 6 months
时间窗: 6 months
Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment
次要结局
- Quality of life with GO-QoL(6 months)
- Change in Modified Clinical activity score(3 and 6 months)
- Quality of life with ThyrPro(6 months)
- Optical coherence tomography(3 and 6 months)
- TPO-Ab(3 and 6 months)
- Quality of life with SF36(6 months)
- TRAb(3 and 6 months)