Perianal Fistula (PAF) Validation and Burden of Illness Study

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981939
• Other study ID #: IBD-5009
• Secondary ID: U1111-1233-6312
• Status: Completed
• Start date: July 2, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3032
• Est. completion date: December 31, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria for Objective 1:

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.

Inclusion Criteria for Objective 2:

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.

Inclusion Criteria for Objective 3:

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.

3. Have to have 5 years of follow-up.

4. Aged 18-105 inclusive at date of index.

Exclusion Criteria for Objective 1:

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.

Exclusion Criteria for Objective 2:

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.

Exclusion Criteria for Objective 3:

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.

4. Meeting the case definition during the lookback period.

Related Conditions & MeSH terms

• Crohn Disease
• Crohns Disease
• Fistula
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Perianal Fistula
• Rectal Fistula

Intervention

Other:
• No intervention
This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.

Locations

Country	Name	City	State
Canada	Takeda Canada	Oakville	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database	Index date first time participant meets case definition(diagnosis of CD with CPAF in index period).Participants divided as:2 diagnosis/imaging codes(IC),2 codes must be in 2 year(yr) period of each other;3 diagnosis/IC/intervention code/EUA+seton;3 diagnosis/IC/intervention code/EUA+seton,diagnosis/IC requirements are satisfied,codes must be in 2yr period of each other;2 diagnosis/IC;3 diagnosis/IC,3 codes must be in 2yr period of each other;3 diagnosis/IC;diagnosis/IC+(EUA+Seton);diagnosis/IC+(EUA+Seton),2 codes must be in 2yr period of each other;3 diagnosis /IC+intervention code 4 codes must be in 2 yr period of each other;2 IC/intervention code/diagnosis code/EUA+seton;2 IC/intervention code/diagnosis code/EUA+seton,IC requirements are satisfied, codes must be in 2yr period of each other;2 diagnosis/IC+intervention code;3 diagnosis/IC+intervention code;2 diagnosis/IC+intervention code,3 codes must be in 2yr period of each other;diagnosis/imaging/intervention codes;diagnosis/IC.	From the date of CD diagnosis up to the index date (approximately 5 years)
Primary	Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF	Impact of total disease burden on participants CD with and without CPAF was measured as total cost and cost by sector which included general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, dialysis, cancer, and radiation, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period.	From the index date up to end of study (approximately 5 years post-index)
Primary	Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database	Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period.	From the index date up to end of study (approximately 5 years post-index)
Primary	Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database	Impact of total disease burden on participants CD with CPAF was based on three procedures which included total cost, total cost (without ODB) and cost by sector i.e. general physicians (GP), specialist, all physician OHIP, home care services, hospital admissions, Dialysis, Cancer, and Radiation, non-hospital based residential care, emergency department (ED), Ontario drug benefit (ODB), hospital outpatient clinics, same day surgery (SDS). Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention.	From the index date up to 5 years post-index
Primary	Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF	Healthcare Resource Utilization was based on three procedures which included the number of ED visits, number of hospitalizations and number of outpatient visits. Index date was defined as the date the first time the participant meets the case definition i.e. diagnosis of CD with CPAF in the index period. Participants with CD and CPAF were categorized into pre-defined treatment pathways and results are reported in three arms: No Intervention, EUA ± Seton and Advanced Intervention.	From the index date up to 5 years post-index