KCT0002222招募中未知
Occurrence of Anti-drug antibody and change of drug level for 1 year after CT-P13 therapy and their Impact on clinical outcomes in moderate to Severe inflammatory bowel disease
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Moderate to severe active Inflammatory Bowel Disease
- •[Moderate to severe criteria]
- •-Crohn's disease: CDAI score = 220, Ulcerative colitis: Mayo score = 6
- •2) Over 19 years of age
- •3) Anti-TNF naive
- •4) Patients who voluntarily signed a consent form
排除标准
- •1) A foreigner
- •2) A history of hypersensitivity to humanized proteins
- •3) Tuberculosis infection
- •4) Chronic hepatitis B not being treated
- •5) HIV infection or positive
- •6) NYHA class III/IV heart disease
- •7) Infection, Malignant tumor, Previous history of dysplasia of the colon or small intestine within the previous 5 years
- •8) Pregnant women, lactating women
研究者
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