Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
研究概览
简要总结
"RUN-CD" is an investigator initiated "Non interventional Trial" on biologics in Crohn´s Disease (CD) patients in Germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of Ustekinumab, with a special interest on predictors of long-term responses and favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.
详细描述
The effectiveness and safety of induction and maintenance therapy of Ustekinumab and other biologics will be assessed in different relevant subgroups of Crohn's Disease patients. To this end, different confounders have to be considered. Patients followed-up for several years will likely receive changing treatments. These changes have to be taken into account. Furthermore, the decision to prescribe, to stop or to continue a treatment depends on the availability of treatment options and experiences with these alternatives:
- Confounding by indication will be taken into account
- Patient characteristics which likely influence the risk of developing a particular endpoint will be taken into account
- The possible influence of co-medication will be considered
- Changing risks over time will be considered
- Power considerations needs to be conducted prior to the comparison of incidence rates
- Appropriate statistical methods will be applied to deal with these challenges
The principles described above will be followed in a similar manner for the analysis of effectiveness and safety endpoints. An appropriate power analysis will be performed before each sub-analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD-patients aged 18-80 years at enrollment written informed consent is given
排除标准
- •planned surgical intervention malignant disease in history lack of adequate documentation possibilities
结局指标
主要结局
Effectiveness of induction therapy in CD-patients treated with Ustekinumab.
时间窗: Week 0 till 16
clinical remission HBI ≤ 4 at week 16
次要结局
- Effectiveness of induction therapy at week 8 in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.(Week 0 till 8)
- Effectiveness of maintenance therapy up to 3 years in CD-patients treated with Ustekinumab vs. anti-TNF/Vedolizumab.(Week 0 till year 3)
- Effectiveness of Ustekinumab in different subpopulations(Week 0 till year 3)
- Measurement of disease activity with HBI(Week 0 till year 3)
- Measurement of Quality of Life with EQ-5D questionnaire(Week 0 till year 3)
- Measurement of disease activity with CDAI(Week 0 till week 16)