IBD Cancer and Serious Infection in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13,262
- 试验地点
- 1
- 主要终点
- assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
研究概览
简要总结
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).
详细描述
The four main secondary objectives of the I-CARE project are:
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To investigate prospectively the impact of anti-TNF based strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
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To assess the evolution of Patient Reported Outcome (ePRO) on a yearly basis and the impact of anti-TNF agents on ePRO in IBD
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To evaluate the benefit-risk ratio of strategies based on an earlier and wider use of anti-TNF therapy for IBD
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To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD 5-ASA and Steroids across Europe At least 5000 IBD patients treated with 5-ASA or Steroids and FU for 3 years
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use of 5-ASA and efficacy (persistence, switch, mucosal healing etc.)
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chemoprevention of CRC: first study that will specifically and accurately address this question
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use of budesonide mmx and efficacy (clinical efficacy, mucosal healing and potential for disease modification)
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safety of steroids (infections etc)
STUDY DESIGN:
22 patients per investigator. Each Investigator will recruit and enrol 20 patients with imposed treatment stratification : Group 1: 5 without previous or ongoing exposure to IS or biologics, (5 ASA and Steroids are allowed) Group 2: 5 with on-going anti-TNF monotherapy Group 3: 5 with thiopurines monotherapy Group 4: 5 with on-going combination therapy Group 5: 2 patients on vedolizumab (on vedolizumab alone and 1 on combination therapy) (optionnal) Group 6: 5 patients treated with ustekinumab with or without any concomitant medications. (optional)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable to complete eDiary on a regular basis, and have access to smartphone or internet
- •Accepted to participate and provide personal information (name, phone and email) for contact
- •Accepted to be contacted by study coordinators on a regular basis for follow up with missing information
排除标准
- •Unable to sign consent
- •Unable to access internet or use smartphone
- •Refused to sign consent or to provide personal identification information
结局指标
主要结局
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
时间窗: 3 years
assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.
次要结局
- Disease modification(3 Years)
- ePRO(3 Years)
- Benefit-Risk(3 Years)
- Cost Efficacy(3 Years)