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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1233-6312 | Other Identifier | World health organization |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD Participants with CPAF - The Ottawa Hospital (TOH) | Participants diagnosed with Complex Perianal Fistula (CPAF) from the Ottawa Hospital (TOH) were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
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| CD Participants without CPAF (ICES database) | Participants diagnosed with CD and without CPAF from Institute for Clinical Evaluative Sciences (ICES) database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
| |
| CD Participants with CPAF (ICES database) | Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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. |
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Inclusion Criteria for Objective 1:
Inclusion Criteria for Objective 2:
Inclusion Criteria for Objective 3:
Exclusion Criteria for Objective 1:
Exclusion Criteria for Objective 2:
Exclusion Criteria for Objective 3:
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Participants diagnosed with CD with and without CPAF will be observed retrospectively in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Canada | Oakville | Ontario | L6H 0J8 | Canada |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of Crohn's disease (CD) with and without Complex Perianal Fistula (CPAF) were enrolled from The Ottawa Hospital (TOH) and Institute for Clinical Evaluative Sciences (ICES) database and were observed retrospectively in this study.
Data from participants were collected for this retrospective observational study at a single investigative site in Canada from 2 July 2019 to 31 December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | CD Participants With CPAF - The Ottawa Hospital (TOH) | Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
| FG001 | CD Participants Without CPAF (ICES Database) | Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
| FG002 | CD Participants With CPAF (ICES Database) | Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All eligible participants with CD, with CPAF or without CPAF from TOH and ICES database were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | CD Participants With CPAF - TOH | Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
| BG001 | CD Participants Without CPAF (ICES Database) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants identified from TOH with and without CPAF were included in the analysis. Participants could meet more than more case definition. | Posted | Count of Participants | Participants | From the date of CD diagnosis up to the index date (approximately 5 years) |
Approximately 5 years
Data of adverse events or adverse drug reactions were not collected as part of the study database.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD Participants With CPAF - The Ottawa Hospital (TOH) | Participants diagnosed with CPAF from TOH were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2019 | Dec 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| From the index date up to end of study (approximately 5 years post-index) |
| 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 |
| 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 |
Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013).
| BG002 | CD Participants With CPAF (ICES Database) | Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | All participants who were eligible as cases (CD Participants with CPAF) and controls (CD Participants without CPAF) from the ICES database were used in the analysis. | Posted | Mean | Standard Deviation | canadian dollars | From the index date up to end of study (approximately 5 years post-index) |
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| 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. | All participants who were eligible as cases (CD Participants with CPAF) and controls (CD Participants without CPAF) from the ICES database were included in the analysis. | Posted | Mean | Standard Deviation | visits | From the index date up to end of study (approximately 5 years post-index) |
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| 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. | All participants who were eligible as cases (CD Participants with CPAF) CPAF from the ICES database were included in the analysis. | Posted | Mean | Standard Deviation | canadian dollars | From the index date up to 5 years post-index |
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| 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. | All participants who were eligible as cases (CD Participants with CPAF) CPAF from the ICES database were included in the analysis. | Posted | Mean | Standard Deviation | visits | From the index date up to 5 years post-index |
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| 0 |
| 549 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | CD Participants Without CPAF (ICES Database) | Participants diagnosed with CD and without CPAF from ICES database who did not meet the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). | 0 | 1,902 | 0 | 0 | 0 | 0 |
| EG002 | CD Participants With CPAF (ICES Database) | Participants with CD and CPAF from ICES database who met the case definition were observed retrospectively in this arm group for the index period (April 1, 2007 to March 31, 2013). | 0 | 581 | 0 | 0 | 0 | 0 |
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Male |
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| Cost by Sector: General Physicians (GP) |
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| Cost by Sector: Specialist |
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| Cost by Sector: All physician OHIP |
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| Cost by Sector: Home Care Services |
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| Cost by Sector: Hospital Admissions |
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| Cost by Sector: Dialysis, Cancer, and Radiation |
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| Cost by Sector: Non-hospital Based Residential Care |
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| Cost by Sector: Emergency Department (ED) |
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| Cost by Sector: ODB |
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| Cost by Sector: Hospital Outpatient Clinics |
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| Cost by Sector: Same Day Surgery (SDS) |
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| Number of Outpatient Visits |
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| Cost by Sector: GP |
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| Cost by Sector: Specialist |
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| Cost by Sector: All physician OHIP |
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| Cost by Sector: Home Care Services |
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| Cost by Sector: Hospital Admissions |
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| Cost by Sector: Dialysis, Cancer, and Radiation |
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| Cost by Sector: Non-Hospital Based Residential Care |
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| Cost by Sector: Emergency department (ED) |
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| Cost by Sector: ODB |
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| Cost by Sector: Hospital Outpatient Clinics |
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| Cost by Sector: SDS |
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| Number of Outpatient Visits |
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