Clinical trial NCT01960439: Responsiveness of Endoscopic Evaluation in UC
Official title: Responsiveness of Endoscopic Evaluation of Ulcerative Colitis Using a Central Reader Based Image Management System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: disease activity
central reader
endoscopic indices
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population contained a broad spectrum of endoscopic and clinical activity. At entry patients had active disease defined by the presence of a modified UCDAI score between 4 and 10.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Central Reading
timeFrame: 2 years
Secondary outcomes:
measure: Endoscopic Responsiveness of endoscopic index to Clinical Change
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Clinical Trials Inc.
state: Ontario
Study officials:
affiliation: Western University
name: Brian Feagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1136/bmj.2.4947.1041. No abstract available.
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. doi: 10.1056/NEJM198712243172603.
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. doi: 10.1056/NEJMoa050516.