Responsiveness of Endoscopic Evaluation in UC

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT01960439
• Lead Sponsor: University of Western Ontario, Canada

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central Reading	2 years	Each of 4 central readers will score approximately 130 videos

Secondary Outcome Measures

Name	Time	Method
Endoscopic Responsiveness of endoscopic index to Clinical Change	2 years	The effect size of each endoscopic index will be calculated.

Trial Locations

Locations (1)

Robarts Clinical Trials Inc.; 🇨🇦 London, Ontario, Canada