Therapeutic Effect of New Biologics in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- endoscopic remission
研究概览
简要总结
New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.
排除标准
- •loss of follow-up, incomplete clinical data, without confirmed diagnosis
结局指标
主要结局
endoscopic remission
时间窗: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2
次要结局
- endoscopic response(short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks))
- clinical remission(short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks))
- clinical response(short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks))