Responsiveness of Endoscopic Evaluation in UC

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01960439

Enrollment

194

Registered

2013-10-10

Start date

2013-07-31

Completion date

2015-07-31

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

disease activity, central reader, endoscopic indices

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Central Reading	2 years	Each of 4 central readers will score approximately 130 videos

Secondary

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

Countries

Canada

Outcome results