NCT03948191已完成4 期
A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.
Dalian University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Responder Status at Week 12
研究概览
简要总结
To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient age 18 Years to 76 Years;
- •Fewer than 6 months from onset of TAO;
- •Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of ≥ 3;
- •Moderate to severe TAO;
- •No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.
排除标准
- •Optic neuropathy, severe orbital appearance and surgical;
- •Extra-thyroid disease;
- •Pregnant and children;
- •Severe impairment of cardiac, hepatic and renal functions;
- •Allergies;
- •Other contraindications.
研究组 & 干预措施
Methylprednisolone(ivMP)
Active Comparator
Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
干预措施: Methylprednisolone (Drug)
99Tc-MDP
Experimental
99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
干预措施: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection) (Drug)
结局指标
主要结局
Responder Status at Week 12
时间窗: Week 12
This end point main evaluation improvement of clinical activity score and proptosis at week 12. A reduction of the CAS 2 point or more, and reduction of the proptosis 2 mm or more was defined as response.
次要结局
- Overall Average Continuous Change in CAS From Baseline to Week 24(Baseline to Week 24)
- Overall Average Continuous Change in Proptosis From Baseline to Week 24(Baseline to Week 24)
- Overall Average Change in Diplopia grading From Baseline to Week 24(Baseline to Week 24)
- Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24(Baseline to Week 24)
- Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up(Baseline to Week 24)
- Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up(Baseline to Week 24)
- Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up(Baseline to Week 24)
研究者
研究点 (1)
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