描述治疗模式并在溃疡性结肠炎中产生更新的治疗流程 (EFFECT-1LAT)
描述溃疡性结肠炎的处方模式并产生更新的溃疡性结肠炎治疗范式
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
研究概览
详细说明
Exploring the long-term outcomes of uncontrolled inflammation, and how does early switching to advanced treatments affect disease outcomes and inflammation control in patients with poorly controlled ulcerative colitis.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Tadworth、英国、KT207NS
- Pfizer
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The Lothian IBD registry (LIBDR) was compiled through a capture-recapture methodology, describes the observed prevalence of IBD in Lothian between 2008 and 2018, and has been maintained as a prospective registry since 1 August 2018 and thus the study period is up to 1st August 2025 (2008 - 2025). The study size is expected to be a defined population of approximately 4000 UC patients, with more than 600 having commenced an advanced therapy. The study period will be from 2008 - 2025.
描述
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patient enrolled in IBD registry from 2009
- >18 years at time of diagnosis.
- Diagnosis of Ulcerative Colitis.
- Patient data entered during the study period.
- Minimum duration of data post UC diagnosis (Cohort A: 6 months, Cohort B-D 6 months)
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cohort A
Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy. |
As provided in real world practice
其他名称：
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Cohort B
Patients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis. |
As provided in real world practice
其他名称：
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Cohort C
Patients with steroid dependent controlled inflammation defined as normal CRP and faecal calprotectin but the requirement of a dose of steroids between 6-24 months. |
As provided in real world practice
其他名称：
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Cohort D
Patients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis |
As provided in real world practice
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.
大体时间：6-24 months from UC diagnosis.
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Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
6-24 months from UC diagnosis.
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Difference in proportion of patients with inadequate control of inflammation (defined as two or more episodes of raised CRP or faecal calprotectin) treated with conventional therapeutics versus treatment escalation 24 months post UC diagnosis.
大体时间：24 months
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Explore the differences in long term outcomes for patients with uncontrolled inflammation, treated with prolonged conventional therapeutics versus treatment escalation up to 24 months for patients with inadequate control of inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
大体时间：Baseline demography.
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Characterise patient demography at the time of UC diagnosis and associated co-morbidities and extra-intestinal manifestations of interest in the Lothian inflammatory bowel disease registry (LIBDR). |
Baseline demography.
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Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from Baseline in Faecal Calprotectin (Fcal).
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from Baseline in C-Reactive Protein (CRP).
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with colectomies from baseline.
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with hospitalisations from baseline.
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.
大体时间：Study period is up to 1st August 2025 (2008 - 2025).
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Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from baseline in control of inflammation (CRP or faecal calprotectin) in patients that are moved from conventional treatments to advanced treatments with a UC diagnosis.
大体时间：From baseline, study period is up to 1st August 2025 (2008 - 2025).
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Describe the effects of changing from conventional treatment to advanced treatments (etrasimod and tofacitinib) in control of inflammation (CRP or faecal calprotectin) in the Lothian inflammatory bowel disease registry (LIBDR). |
From baseline, study period is up to 1st August 2025 (2008 - 2025).
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合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- C5041058
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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