Perianal Fistula (PAF) Validation and Burden of Illness Study

NCT03981939 | Completed Results

• 2 other identifiers: IBD-5009U1111-1233-6312
• Study Type: observational
• Target: 3,032
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease; Perianal Fistula; Crohns Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Study Arms (3)

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).

Other: No intervention

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).

Other: No intervention

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).

Other: No intervention

Interventions

No intervention OTHER

This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.

CD Participants with CPAF (ICES database); CD Participants with CPAF - The Ottawa Hospital (TOH); CD Participants without CPAF (ICES database)

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with CD with and without CPAF will be observed retrospectively in this study.

You may qualify if:

• Aged 18-105 inclusive at date of index.
• Participant can be linked between TOH "reference" database to the Institute for Clinical Evaluative Sciences (ICES) databases based on health card number.
• Incident diagnosis of CPAF in TOH database between April 1, 2004 to July 1, 2015.
• Participants were incident in the OCCC from April 1, 2002 to March 31, 2012.
• The case meets the PAF case definition identified in Objective 1 in the selection period (April 1, 2005 to March 31, 2012).
• Aged 18-105 inclusive at date of index.
• The case meets the CPAF case definition identified in Objective 1 in the selection period.
• Have to have 5 years of follow-up.
• Aged 18-105 inclusive at date of index.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Canada

Oakville, Ontario, L6H 0J8, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: July 2, 2019
• Primary Completion: December 17, 2019
• Study Completion: December 31, 2019
• Last Updated: April 21, 2021
• Results First Posted: April 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

CA (1)