Responsiveness of Endoscopic Evaluation in UC

Study Overview
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Brief Summary
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The purpose of this study of this study is to assess the responsiveness and validity of CIMS (Central Image Management System)-based endoscopic evaluation of UC (Ulcerative Colitis) clinical disease activity by measuring: The responsiveness central reader endoscopic EIs [(Endoscopic Indices) (MMCS (Modified Mayo Clinic endoscopy Subscore), UCEIS (Ulcerative Colitis Endoscopic Index of Severity) MBS (Modified Baron Score)] to clinical change from baseline to week 6 in a prospective trial of a treatment of known efficacy in UC.

Detailed Description
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This study will evaluate the responsiveness central reader based EIs for assessing clinical disease activity. Endoscopic images will be obtained from recent large multicenter randomized clinical trial and assessed using utilizing CIMS readers using EIs (MMCS, UCEIS, MBS) and a VAS (visual analog scale). The primary efficacy endpoint of this trial was clinical and endoscopic remission at week 6, with a secondary endpoint of endoscopic and clinical remission at week 10. For the same subjects, clinical data will be obtained including a modified UCDAI (Ulcerative Colitis Disease Activity Index). Central readers are blinded to clinical scores.

Official Title
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Responsiveness of Endoscopic Evaluation of Ulcerative Colitis Using a Central Reader Based Image Management System

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active ulcerative colitis disease defined by the presence of a modified UCDAI score between 4 and 10 Only patients who had an MMCS endoscopy subscale score according to a single reader Endoscopic videos recorded for CIMS based central reader assessment Exclusion Criteria: UCDAI score less than 4 and greater than 10

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic evaluation<br>The study population contained a broad spectrum of endoscopic disease and clinical activity. At entry to the trial patients had active disease defined by the presence of a modified UCDAI score between 4 and 10.1 Only patients who had a MMCS endoscopy subscale score according to a single central reader (n= 194 of 281 participants) were eligible for assessment in the current study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Reading | Each of 4 central readers will score approximately 130 videos | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Responsiveness of endoscopic index to Clinical Change | The effect size of each endoscopic index will be calculated. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disease activity, central reader, endoscopic indices