CTIS2023-506656-24-00进行中（未招募）1 期
Immediate corticosteroid therapy and rituximab to prevent generalization in ocular myasthenia gravis: a PROBE-type multicenter, open-label, randomized controlled trial
Hopital Fondation Adolphe De Rothschild0 个研究点目标入组 128 人开始时间: 2023年12月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients over 18 years old, Diagnosis of ocular myasthenia within the last 6 months, defined : either by a typical clinical examination objectified by an expert clinician: ptosis and/or binocular diplopia, with a variable and fluctuating character (either spontaneous or provoked by effort or rest) ; or by positive anti-AChR antibodies or the presence of a decrement on repetitive nerve stimulation or a positive edrophonium test, Ocular symptoms lasting at least one month and limited to extra-ocular muscles (weakness in one or both orbicularis oculi), No non-ocular symptoms on MMS, MGC and MG-ADL, Immunosuppressive therapy-naive management of ocular myasthenia gravis, Having received information about the study and having signed a consent to participate in the study, Affiliated to a social security system
排除标准
- •Thymoma, Hypersensitivity to paracetamol, Hypersensitivity to dexchlorpheniramine, Any infectious condition, Patients with severe immune deficiency, Severe heart failure (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease, Severe liver failure, Psychotic state not yet controlled by treatment, Hyperuricemia on xanthine oxidase inhibitors (allopurinol and febuxostat), Risk of angle-closure glaucoma, Risk of urinary retention due to urethro-prostatic disorders, Pupillary anomaly other than that resulting from disease or previous local surgery., Vaccination with live attenuated vaccine required during study and up to 6 months after rituximab discontinuation, Women of childbearing age* who do not wish to use effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate <1%) during their participation and at least 12 months after the last dose (oral commitment by the patient recorded in the file by the investigator), Pregnant or breast-feeding women, Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care by virtue of articles L.3212-1 and L.3213-1, Persons under psychiatric care pursuant to articles L.3212-1 and L.3213-1 and persons admitted to a health or social establishment for purposes other than research (L.1121-6) to a health or social establishment for purposes other than research (L.1121-6), Adults under legal protection (L.1121-8), Signs of restrictive abduction or supraduction myopathy due to dysthyroid ophthalmopathy, Graves' ophthalmopathy, Onset of ocular symptoms more than one year before screening date, Hypersensitivity to rituximab or murine proteins, Hypersensitivity to prednisone, Hypersensitivity to methylprednisone, Hypersensitivity to aziathioprine or 6-mercaptopurine
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