ACTRN12623001336673尚未招募2 期
Comparing Use of B-cell depletion therapy to Immunoglobulin in Chronic inflammatory demyelinating polyneuropathy (CUBIC) clinical trial.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adult greater than 18 years with a documented diagnosis of CIDP, according to the European Federation of Neurological Societies/ Peripheral Nerve Society (EFNS/PNS) criteria 2021
- •3 doses of TGA approved COVID-19 vaccinations.
- •at least 2 weeks post 3rd dose COVID-19 vaccination.
- •greater than 4 months on Ig therapy and planned continuation for at least 9 months.
- •No previous history of B-cell depletion therapy.
- •Other immunosuppressants acceptable if dose is stable for 6+ months
排除标准
- •Pregnancy or planned pregnancy in the next 12 months
- •Has not had 3 doses of TGA approved COVID-19 vaccinations
- •Underlying primary immunodeficiency
- •Current or planned treatment with plasma exchange
- •Intolerance or allergy to RIXIMYO (Rituximab), or its incipient
- •Contraindication for RIXIMYO (Rituximab) based on infectious disease screening.
- •Diagnosis of diabetes mellitus
- •Positive MAG antibodies, paranodal/nodal antibodies
研究者
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