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NCT Number: NCT01960439

Responsiveness of Endoscopic Evaluation in UC

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robarts Clinical Trials Inc.

London, Ontario, N6A 5K8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Central Reading

    Time frame: 2 years

    Each of 4 central readers will score approximately 130 videos

Secondary outcomes

  1. Endoscopic Responsiveness of endoscopic index to Clinical Change

    Time frame: 2 years

    The effect size of each endoscopic index will be calculated.

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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