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Perianal Fistula (PAF) Validation and Burden of Illness Study | Clinical Trials | Clareo Health

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Perianal Fistula (PAF) Validation and Burden of Illness Study

Perianal Fistula Procedure Validation, Matched Case Control, and Patient Journey Study

NCT03981939•Takeda

Summary

The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.

Detailed Description

This is a retrospective follow-up observational study of participants with CD with and without complex perianal fistula (CPAF) from January 2002 to March 2017. The study will verify the potential of using procedure codes to reliably identify participants with CPAF in Validation Study (Objective 1), compare Crohn's participants with CPAF (cases) to matched participants without CPAF (controls) to determine the disease burden and healthcare resource utilization of Crohn's related CPAF in Ontario, and will describe the participant's journey among Crohn's participants following the first diagnosis of CPAF (Objective 3). The study will enroll approximately 600 participants (300 participants with CPAF and 300 participants without CPAF). All participants will be enrolled in 2 observation groups: * CD Participants with/without CPAF (ICES data) * CD Participants with CPAF - The Ottawa Hospital (TOH) The data will be collected through Ontario health administrative data. Participants will be observed retrospectively who were diagnosed with CD with and without fistula between index period: April 2002 and July 2013. Participants will be followed up retrospectively from the index period (that is onset of CPAF) to the end of study (Objective 2), and for 5 years following the (Objective 3) index date defined as onset of CPAF will be selected based on the first time they meet the first code in the case definition identified in Objective 1 between April 1, 2005 to March 31, 2012. The overall time for data collection in this study will be approximately 7 months.

Eligibility

Age

18 - 105 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Inclusion in the TOH "reference" database.
•2. Aged 18-105 inclusive at date of index.
•3. Participant can be linked between TOH "reference" database to the Institute for Clinical Evaluative Sciences (ICES) databases based on health card number.
•4. Incident inclusion in the Ontario Crohn's and Colitis Cohort (OCCC) between April 1, 2002 to July 1, 2013.
•5. Incident diagnosis of CPAF in TOH database between April 1, 2004 to July 1, 2015.
•1. Participants were incident in the OCCC from April 1, 2002 to March 31, 2012.
•2. The case meets the PAF case definition identified in Objective 1 in the selection period (April 1, 2005 to March 31, 2012).
•3. Aged 18-105 inclusive at date of index.
•1. Inclusion in the OCCC at or prior to index visit with a diagnosis of Crohn's disease.
•2. The case meets the CPAF case definition identified in Objective 1 in the selection period.
+2 more criteria

Exclusion Criteria

•1. Missing demographics at index date (sex, age, Local Health Integration Network (LHIN), income quintile) in all databases.
•2. Death date in the ICES data prior to TOH CPAF incidence date.
•1. Missing demographics at index date (sex, age, neighbourhood income quintile, LHIN).
•2. Death during 5-year analysis period.
•3. Ontario Health Insurance Plan (OHIP) coverage is terminated during the follow-up example if the participant moves to another province.
•4. Meeting the case definition during the lookback period.
•5. Cases for whom a matched control cannot be found.
•1. Missing demographics at index date (sex, age, neighbourhood income quintile, LHIN).
•2. Death during 5-year analysis period.
•3. OHIP coverage is terminated during the 5-year analysis period example if the participant moves to another province.
+1 more criteria

Locations (1)

Takeda Canada

Oakville, Ontario, Canada

Key Dates

Start Date

July 2, 2019

Primary Completion Date

December 17, 2019

Completion Date

December 31, 2019

Last Updated

April 21, 2021

Enrollment

3,032

ACTUAL participants

Conditions

Inflammatory Bowel DiseasePerianal FistulaCrohns Disease

Interventions

No intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Perianal Fistula (PAF) Validation and Burden of Illness Study

Inclusion Criteria

Exclusion Criteria

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