Responsiveness of Endoscopic Evaluation in UC

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960439
• Other study ID #: RP1302
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: December 1, 2015
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Canada	Robarts Clinical Trials Inc.	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JW, Rutgeerts P, Munkholm P, Mittmann U, King D, Wong CJ, Zou G, Donner A, Shackelton LM, Gilgen D, Nelson S, Vandervoort MK, Fahmy M, Loftus EV Jr, Panaccione R, Travis SP, Van Assche GA, Vermeire S, Levesque BG. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013 Jul;145(1):149-157.e2. doi: 10.1053/j.gastro.2013.03.025. Epub 2013 Mar 22. — View Citation

Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. Erratum in: N Engl J Med. 2006 May 18;354(20):2200. — View Citation

Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. — View Citation

TRUELOVE SC, WITTS LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J. 1955 Oct 29;2(4947):1041-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Reading	Each of 4 central readers will score approximately 130 videos	2 years	No
Secondary	Endoscopic Responsiveness of endoscopic index to Clinical Change	The effect size of each endoscopic index will be calculated.	2 years	No