N/A
N=3,032
Perianal Fistula (PAF) Validation and Burden of Illness Study
Inflammatory Bowel Disease · Perianal Fistula · Crohns Disease
Bottom Line
View on ClinicalTrials.gov: NCT03981939 ↗Enrolled (actual)
3,032
Serious AEs
—
Results posted
Apr 2021
Primary outcome: Primary: Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database — 120; 120; 127; 127 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database |
120; 120; 127; 127; 88; 97 | — |
| PRIMARY Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF |
32781.12; 62375.54; 22866.85; 36486.07; 1192.63; 1275.58 | — |
| PRIMARY Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database |
4.26; 5.57; 0.95; 1.38; 8.57; 15.18 | — |
| PRIMARY Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database |
45982.45; 65430.16; 142034.86; 26799.65; 36992.93; 94326 | — |
| PRIMARY Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF |
5.29; 5.11; 11.22; 1.06; 1.37; 3.57 | — |
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.
Eligibility Criteria
Inclusion Criteria for Objective 1:
- Inclusion in the TOH "reference" database.
- 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 inclusion in the Ontario Crohn's and Colitis Cohort (OCCC) between April 1, 2002 to July 1, 2013.
- Incident diagnosis of CPAF in TOH database between April 1, 2004 to July 1, 2015.
Inclusion Criteria for Objective 2:
- 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.
Inclusion Criteria for Objective 3:
- Inclusion in the OCCC at or prior to index visit with a diagnosis of Crohn's disease.
- 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.
Exclusion Criteria for Objective 1:
- 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.
Exclusion Criteria for Objective 2:
- 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.
Exclusion Criteria for Objective 3:
- 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.
Data sourced from ClinicalTrials.gov (NCT03981939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.