JPRN-jRCTs051200137招募中未知
Efficacy and safety of methylprednisolone pulse therapy for ocular myasthenia gravis: a pilot study - ESPRETHO
Koh Jinsoo0 个研究点目标入组 10 人开始时间: 2021年2月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Diagnosed of OMG without thymoma with any of the symptoms of ocular motility disorder, ptosis, or facial muscle weakness showing easy fatigue
- •(2) One or more positive findings of either A or B:
- •A. Pathogenic autoantibodies (1 or 2)
- •1 Anti-acetylcholine receptor (AChR) antibody
- •2 Anti-muscle-specific receptor tyrosine kinase (MuSK) antibody
- •B. Neuromuscular junction disorders (one or more of the following)
- •1 Eyelid fatigue test
- •2 Ice pack test
- •3 Edrophonium test
- •4 Repeated stimulation test
- •5 Increased jitter in single-fiber EMG
- •(3) An ocular MG-ADL scale 1 or higher, and ocular symptoms that interfere with daily activities
- •(4) Treating the maximum dose of AChE-I or difficulty increasing the dose of AChE-I due to adverse events
- •(5) Aged 20 years or older
- •(6) Capable of providing informed consent and complying with study procedures
排除标准
- •(1) Disease duration 10 years or more after onset
- •(2) Treatment with systemic corticosteroids, immunosuppressive drugs, immunoglobulins or plasmapheresis within 90 days of enrollment.
- •(3) Patients with thymoma (post-resection patients are acceptable)
- •(4) Poorly controlled diabetes (HbA1c 8.0% or more)
- •(5) Poorly controlled glaucoma
- •(6) Poorly controlled hypertension (systolic blood pressure 180 mmHg or higher, or diastolic blood pressure 100 mmHg or higher)
- •(7) prior steroid intolerance
- •(8) Obesity (BMI over 40 kg/m2)
- •(9) A history of osteoporotic fracture
- •(10) HBs antigen positive or HBV-DNA amount detection sensitivity or higher, or HCV antibody positive
- •(11) Tuberculosis infection within 2 years, or interferon gamma release assay (T-spot. TB or QFT) positive
- •(12) Active thyroid disease, liver or renal failure, poorly controlled cardiac or blood disease, active peptic ulcer or infection, or any other illness that would make it unsafe for the patient to participate in the trial
- •(13) Pregnant or lactating
- •(14) Receipt of another study within 30 days prior to enrollment
研究者
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