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Responsiveness of Endoscopic Evaluation in UC

NCT ID: NCT01960439

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Feagan, MD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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Robarts Clinical Trials Inc.

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 23528626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13260656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3317057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16339095 (View on PubMed)

Other Identifiers

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RP1302

Identifier Type: -

Identifier Source: org_study_id