DESCRIBING PRESCRIPTION PATTERNS IN AN ULCERATIVE COLITIS POPULATION AND GENERATING AN UPDATED ULCERATIVE COLITIS TREATMENT PARADIGM
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
详细描述
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Non-Interventional Study (Drug)
Cohort A
Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy.
干预措施: Non-Interventional Study (Drug)
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.
干预措施: Non-Interventional Study (Drug)
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
干预措施: Non-Interventional Study (Drug)
结局指标
主要结局
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.
时间窗: 24 months
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).
Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.
时间窗: 6-24 months from UC diagnosis.
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).
次要结局
- Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.(Baseline demography.)
- Change from Baseline in Faecal Calprotectin (Fcal).(Study period is up to 1st August 2025 (2008 - 2025).)
- Change from Baseline in C-Reactive Protein (CRP).(Study period is up to 1st August 2025 (2008 - 2025).)
- Proportion of patients with colectomies from baseline.(Study period is up to 1st August 2025 (2008 - 2025).)
- Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.(Study period is up to 1st August 2025 (2008 - 2025).)
- Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.(Study period is up to 1st August 2025 (2008 - 2025).)
- Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.(Study period is up to 1st August 2025 (2008 - 2025).)
- Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.(Study period is up to 1st August 2025 (2008 - 2025).)
- Proportion of patients with hospitalisations from baseline.(Study period is up to 1st August 2025 (2008 - 2025).)
- 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.(From baseline, study period is up to 1st August 2025 (2008 - 2025).)