KCT0002163进行中（未招募）未知
Multi-center (in Korea and Japan), double-blind, randomized, parallel-group study to evaluate similarity of efficacy and safety of LBEC0101 50mg subcutaneous weekly injection to Enbrel® 50mg subcutaneous weekly injection, as adjunctive therapy to Methotrexate (MTX), in patients with active rheumatoid arthritis who had an inadequate response to MTX
G Life Sciences0 个研究点目标入组 372 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 372
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
- •- Diagnosed as having RA according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 6 months prior to screening
- •- Patients who have inadequate response to methotrexate administered for at least 12 weeks before the beginning of screening period and on a stable dose.
排除标准
- •- patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-? release assay at screening
- •- patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
- •- patients with any seropositive result for hepatitis B or hepatitis C or HIV
- •- patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
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