Responsiveness of Endoscopic Evaluation in UC

• Sponsor: University of Western Ontario, Canada (Other)
• Overall Status: Completed
• CT.gov ID: NCT01960439
• Collaborator: (none)
• Enrollment: 194
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 194 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Responsiveness of Endoscopic Evaluation of Ulcerative Colitis Using a Central Reader Based Image Management System
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Endoscopic evaluation 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.

Outcome Measures

Primary Outcome Measures

1. Central Reading [2 years]

   Each of 4 central readers will score approximately 130 videos

Secondary Outcome Measures

1. Endoscopic Responsiveness of endoscopic index to Clinical Change [2 years]

   The effect size of each endoscopic index will be calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robarts Clinical Trials Inc.	London	Ontario	Canada	N6A 5K8

Sponsors and Collaborators

• University of Western Ontario, Canada

Investigators

• Principal Investigator: Brian Feagan, MD, Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Feagan BG, Sandborn WJ, D'Haens G, Pola S, McDonald JWD, 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.
• 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.
• 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.
• TRUELOVE SC, WITTS LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J. 1955 Oct 29;2(4947):1041-8.

• Responsible Party: University of Western Ontario, Canada
• ClinicalTrials.gov Identifier: NCT01960439
• Other Study ID Numbers: RP1302
• First Posted: Oct 10, 2013
• Last Update Posted: Dec 2, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by University of Western Ontario, Canada: disease activity; central reader; endoscopic indices
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Dec 2, 2015