JPRN-jRCT2041220136招募中3 期
A multicenter, open-label study to investigate the efficacy and safety of GB-0998 for the treatment of neurological neuropathy in patients with Eosinophilic Granulomatosis with Polyangiitis(EGPA).
Amano Koichi0 个研究点目标入组 25 人开始时间: 2023年2月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Men and women aged 18 years and older at the time of informed consent.
- •-Patients who have received an explanation of the study through the informed consent form approved by the Institutional Review Board and have signed the form prior to any study-related procedure specified in the
- •-Patients with a diagnosis of definite EGPA based on the diagnostic criteria of the Ministry of Health and Welfare of Japan (1998).
- •-Patients with residual neuropathy after the following corticosteroid therapies 1) and 2) for EGPA prior to
- •informed consent.
- •1) Induction therapy with 40 mg/day or more of prednisolone (or an equivalent dosage of another
- •corticosteroid) for at least 4 weeks, followed by a reduction of dosage and then
- •2) Maintenance therapy with 5 to 20 mg/day of prednisolone (or an equivalent dosage of another
- •corticosteroid) for at least 4 weeks.
- •-Patients with the manual muscle testing (MMT) of a score of be equal to 3 or less on at least one item AND a sum MMT score of less than 130 at provisional enrollment and at definitive enrollment.
排除标准
- •-Patients whose a sum score of the MMT at the definitive enrollment improved by at least 10% of room for
- •improvement in a sum score of the MMT at the provisional enrollment. (the score at the definitive enrollment - the score at the provisional enrollment)/(144 -the score at the provisional enrollment) not lower than 0.1).
- •-Patients who have used any prohibited drug (defined separately) during the period between informed
- •consent and the start of study drug administration.
- •-Patients with muscle atrophy considered ineligible for this drug.
- •-Patients who have received a total of 2.0 g/kg of human immunoglobulin G to treat an autoimmune or
- •inflammatory disease within 12 months before informed consent.
- •-Patients who have received cyclophosphamide within 4 weeks before informed consent.
- •-Patients who have newly started mepolizumab within 24 weeks before informed consent.
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