KCT0007097尚未招募未知
A Multicenter, randomized, controlled, parallel group, open, 32-week study to assess the non-inferiority of methotrexate(MTX) and Leflunomide(LEF) combination therapy compared to triple combination(MTX, Hydroxychloroquine(HCQ), Sulfasalazine(SSZ)) therapy in MTX inadequate response rheumatoid arthritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 190
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
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(1) The patients are older then 19 years old, at the time of signing the subject consent form
- •(2) A patient who has voluntarily decided to participate in the clinical trial after hearing the explanation about this clinical trial,
- •(3) Patients diagnosed with rheumatoid arthritis at least 2 months before screening
- •(4) Patients with active rheumatoid arthritis with DAS28-CRP=3.2 at screening and baseline
排除标准
- •(1) Currently, patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, thyroid, blood, psychoneurologic, or metabolic/electrolyte abnormalities.
- •(2) Patients who have a history of any of the following diseases or are currently accompanied by the following diseases
- •? Demyelinating disorders, Multiple sclerosis, Guillain-Barre syndrome, etc.
- •? Lymphoproliferative diseases
- •(3) Patients with a history of any of the following diseases within 24 weeks prior to the first administration of the investigational drug or who are currently accompanied by the following diseases
- •? Serious infectious disease*
- •*: Pneumocystis pneumonia, Pyelonephritis, etc.
- •? Opportunistic infection*
- •*: Cytomegalovirus infection, Herpes zoster, etc.
研究者
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