NCT01960439

Responsiveness of Endoscopic Evaluation in UC

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: University of Western Ontario, Canada · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-10-10
• Last updated: 2015-12-02

Locations

1 site across 1 country: Canada