Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany Documentation of Vedolizumab Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response
试验速览
- 阶段
- 不适用
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement)
研究概览
简要总结
This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model to predict long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with biologics. Little data are available on the efficacy and safety of biologics in Germany in a real world situation. While the increasing use of anti-TNF-alpha antibodies in IBD-patients the new therapy with Vedolizumab opens up new opportunities in IBD-therapy, it may also pose new options and problems in terms of efficacy and predictors of response and potential side effects.
详细描述
The IBD-patients will be prospectively documented in the BIOibd-Registry. The diagnosis is made in accordance with current DGVS/ECCO UC/CD guidelines. There are the following inclusion and exclusion criteria:
Inclusion Criteria:
- IBD-patients (UC/CD) aged 18-80 years at enrollment
- Written informed consent is given Exclusion Criteria:Lack of adequate documentation possibilities
- Malignant disease in history
- Planned surgical intervention
There are three subpopulations:
- IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
- IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
- IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed < 2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
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
- •IBD-patients (UC/CD) aged 18-80 years at enrollment
- •Written informed consent is given
排除标准
- •Lack of adequate documentation possibilities
- •Malignant disease in history
- •Planned surgical intervention
结局指标
主要结局
safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement)
时间窗: through study completion, an average of 1 year
Success - no; Failure - yes
次要结局
- Efficacy (remission and response) of induction therapy (week 14)(through study completion, an average of 1 year)
- Efficacy (remission and response) of maintenance therapy (month 6 and 12)(through study completion, an average of 1 year)
- Development of a multifactorial model to predict a favorable course of disease(through study completion, an average of 1 year)
- Generation of follow-up data on IBD-patients with early disease(through study completion, an average of 1 year)
- Formation of a large-scaled patient-collective of IBD-patients with an early course of disease(through study completion, an average of 1 year)
- Efficacy (remission and response) of effectiveness in different subpopulations(through study completion, an average of 1 year)
- Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease(during the first 14 weeks after individual participation)
- Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects(through study completion, an average of 1 year)
- Generation of health economic data in IBD-patients on biologicals(through study completion, an average of 1 year)