JPRN-UMIN000035753已完成2 期
The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial
agoya University Hospital0 个研究点目标入组 27 人开始时间: 2019年2月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
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
- 12years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients with disease meeting one of the following exclusion criteria defined in the modified EFNS/PNS diagnostic criteria. 2. Patients who have started or have increased the dose of corticosteroids for CIDP within 12 weeks prior to the enrollment 3. Patients who have started or have increased the dose of IVIg within 8 weeks prior to the enrollment 4. Patients who have undergone plasmapheresis within 8 weeks prior to the enrollment or patients with refractory disease not responding adequately to 8 weeks of plasmapheresis (plasma exchange or double-filtration plasmapheresis) 5. Patients who have started or have increased the dose of an immunosuppressant within 12 weeks prior to the enrollment 6. Patients who have undergone hematopoietic stem cell transplant prior to the enrollment 7. Patients who have used rituximab prior to the enrollment 8. Patients who have participated in another clinical study within 3 months prior to the enrollment or patients who are participating in another study 9. Patients with poorly controlled diabetes 10. Patients who have or are suspected to have active infection 11. Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody(patients with positive HBs antibody or HBc antibody can be enrolled when a HBV-DNA test is negative, and hepatitis B virus-DNA and aspartate/alanine transaminase levels are monitored at fixed intervals), or patients with positive HIV antibody or HTLV-1 antibody 12. Patients with leukopenia, neutropenia, or lymphopenia 13. Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products 14. Patients with serious comorbidity 15. Female patients who are pregnant, lactating, or potentially pregnant, or patients who are not willing to use contraceptive measures during the study period 16. Patients who are judged to be unsuitable by the investigator or a sub-investigator
研究者
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