NCT01969019Unknown4 期
A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should meet the criteria of either a or b and together with c, d and e to include into the study.
- •a. Lid retraction with any one of the following: i) Thyroid dysfunction ii) Proptosis iii) Optic nerve involvement iv) Extraocular muscle involvement b. Thyroid dysfunction with any one of the following: i) Proptosis ii) Optic nerve involvement iii) Extraocular muscle involvement c. Exclude cases with such ophthalmological signs caused by other diseases. d. Moderate to severe patients defined by EUGOGO. e. Clinical activity score (CAS)≥3/7 f. Normal function of heart, liver and kidney.
排除标准
- •Orbital decompression surgery needed immediately
- •History of chronic recurrent or active infection
- •History of peptic ulcer
- •Patients with a history of chronic liver disease or liver disorders； ALT or AST above 2.5 times upper limit of normal
- •History of HIV, hepatitis C or hepatitis B Positive
- •Cardiovascular or cerebrovascular disease clinically significant
- •Uncontrolled diabetes mellitus
- •Use of corticosteroids during 12 weeks before to inclusion period
- •Pregnant patient or patient who is planning to become pregnant during the study
研究组 & 干预措施
methylprednisolone
Active Comparator
intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks
干预措施: methylprednisolone, prednisone (Drug)
methylprednisolone plus prednisone
Active Comparator
intravenous MP 0.5g daily for three days per week, twice, followed by 0.25g daily for three days per week, twice, and followed by tapering oral prednisone (starting with 60mg/d, then10 mg less/week than each previous week for the next 3 weeks, then20mg/week at the 5th week followed with 5mg less/week than each previous week for the next 3 weeks)
干预措施: methylprednisolone, prednisone (Drug)
结局指标
主要结局
response rate
时间窗: 3 months
次要结局
- change of CAS, adverse effects and retreat(3 months)
研究者
研究点 (1)
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