KCT0005867招募中未知
Open, Phase ?, Investigator Initiated Trial to Evaluate the Safety and Efficacy of E4 for Patient with Systemic Juvenile Idiopathic Arthritis (SJIA)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 5
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
- 2(Year) 至 18(Year)（—）
- 性别
- All
入选标准
- •1.Subject Aged 2 to 18 years who meet the criteria for SJIA (ILAR criteria)
- •2. Subject with an inadequate response, dependence, resistance or side effect to current treatment (NSAIDs and/or corticosteroid)
- •3. Subject with intermittent fever (body temperature > 38°C) at least 2 days from within 1 week prior to the screening visit and during the screening period
- •4. Screening laboratory values must meet the following criteria
- •WBC = 2,500 /µL
- •Hemoglobin (Hb) = 8.0 g/dL (transfusion permitted)
- •Platelet = 100,000 /µL
- •CRP = 1.5 x ULN or ESR = 1.5 x ULN
- •5. Informed consent provided by the subject (as required by local law), or by the subject's legally authorized representative(s) with the assent of subject who are legally capable of providing it, as applicable
排除标准
- •1. Subject with other autoimmune disease, rheumatoid disease or symptom that overlap other than SJIA
- •2. History of cancer or lymphoma
- •3. History of organ or bone marrow transplant surgery
- •4. Known infection with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
- •5. Subject with clinically significant conditions associated with immunodeficiency
- •6. History of significant cardiac disease caused by SJIA
- •7. History of severe infectious disease that require hospitalization or treatment within 4 weeks prior to the screening visit
- •8. Active tuberculosis or history of tuberculosis that require treatment within 2 years prior to the screening visit
- •9. Subject treated with biological agent(TNF inhibitors, IL-1 inhibitor, IL-6 inhibitor, etc.) within 4 weeks prior to initiation of study treatment
- •10. Administration of live attenuated vaccine within 4 weeks prior to initiation of study treatment
- •11. Subject are administrated investigational product in any other type of clinical trial within 4 weeks prior to initiation of study treatment
- •12. Known hypersensitivity reaction to the study drug ingredients
- •13. Pregnant or nursing (lactating) female subjects
- •14. Subject who do not agree to use a proper contraceptive methods
研究者
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