Responsiveness of Endoscopic Evaluation in UC

University of Western Ontario, Canada

Status: Completed

Conditions: Ulcerative Colitis

Study type: Observational

Funder types: Other

Identifiers

NCT01960439

RP1302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

194 participants in 1 patient group

Endoscopic evaluation

Description:

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.