APOLLO Study: pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- correlation between histological disease activity and disability
研究概览
简要总结
Background and rationale:
In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized.
Objectives and design:
To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.
详细描述
After informed consent, patients will undergo endoscopic assessment evaluating endoscopic disease activity using established scoring systems
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Mayo endoscopic sub-score5
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Ulcerative Colitis Endoscopic Index of Severity [UCEIS]6 All endoscopic assessments will be recorded, allowing blinded scoring by independent endoscopists afterwards. Study protocol APOLLO - 2 During endoscopy, colonic biopsies will be taken according to standard of care from the most inflamed area of the colon and normal area if applicable, 0-60cm from the anal verge. All biopsies will be scored histologically using the Nancy Index.7 During the same study visit, clinical symptoms (Simple clinical colitis activity index [SCCAI]) and patient reported outcomes (PROMs) will be evaluated digitally using validated scoring systems8
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IBD disk
-
PRO-2
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Visual Analogue Scale
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IBD control in case of non-remission Finally, patients will be biochemically (C-reactive protein, hemoglobin, albumin) evaluated, including measurement of drug level (infliximab, adalimumab, vedolizumab) in case of ongoing exposure to biological agents. All evaluations are part of standard-of-care. Definitions
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Endoscopic remission: Mayo endoscopic sub-score 0 AND UCEIS 0
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Endoscopic response according to
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Mayo score: decrease in Mayo endoscopic sub-score ≥ 1
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UCEIS: decrease in UCEIS ≥ 2
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Endoscopic improvement: Mayo endoscopic sub-score 1
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Histological remission: Nancy histological index 0
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Absence of active/acute histological inflammation: Nancy histological index 0-1
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Histological response: Nancy histological index > 1
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PRO2 remission: stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1-2 stools more than usual) AND rectal bleeding score of 0 (average of 3 days prior to endoscopy)
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IBD disk remission per item:
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Abdominal pain
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Regulating defecation
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Interpersonal interactions
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Education and work
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Sleep
-
Energy
-
Emotions
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Body Image
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Sexual function
-
Joint pain
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
correlation between histological disease activity and disability
时间窗: 1 day
histological activity is based on the Nancy score, disability is based on the IBD disk
次要结局
- correlation between histological disease activity and endoscopic disease activity(1 day)
- correlation between histological disease activity and patient reported outcomes(1 day)
- correlation between histological disease activity and biomarkers(1 day)