Perianal Fistula (PAF) Validation and Burden of Illness Study
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|ClinicalTrials.gov Identifier: NCT03981939|
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : July 17, 2019
|Condition or disease|
|Crohn Disease Inflammatory Bowel Disease Perianal Fistula|
This is a retrospective follow-up observational study of participants with CD with and without PAF from January 2002 to March 2017. The study will verify the potential of using procedure codes to reliably identify participants with PAF in Validation Study (Objective 1), compare Crohn's participants with PAF (cases) to matched participants without PAF (controls) to determine the disease burden and healthcare resource utilization of Crohn's related PAF in Ontario, and will describe the participant's journey among Crohn's participants following the first diagnosis of PAF (Objective 3).
The study will enroll approximately 600 participants (300 participants with PAF and 300 participants without PAF). All participants will be enrolled in 2 observation groups:
- CD Participants with PAF
- CD Participants without PAF
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 April 2002 and July 2013. Participants will be followed up retrospectively from the index period (that is onset of PAF) to the end of study (Objective 2), and for 5 years following the index date (Objective 3). The overall time for data collection in this study will be approximately 7 months.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Perianal Fistula Procedure Validation, Matched Case Control, and Patient Journey Study|
|Actual Study Start Date :||July 2, 2019|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
CD Participants with PAF
Participants diagnosed with CD and PAF from The Ottawa Hospital (TOH) will be observed retrospectively for 5 years.
CD Participants without PAF
Participants diagnosed with CD and without PAF from the TOH will be observed retrospectively for 5 years.
- Objective 1: Number of Crohn's Disease Participants Who Have PAF Using Various Codes in an Administrative Database [ Time Frame: From the date of Crohn's Disease (CD) diagnosis up to the index date (approximately 15 years) ]
- Objective 2: To Determine the Mean Costs and Healthcare Resource Utilization for Crohn's Disease Participants With and Without PAF [ Time Frame: From the index date up to end of study (approximately 5 years) ]
- Objective 3: To Evaluate the Participant Journey With Respect to the Number and Types of Interventions or Procedures for Crohn's Disease Participants with PAF [ Time Frame: From the index date up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981939
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Oakville, Ontario, Canada, L6H 0J8|
|Study Director:||Medical director||Takeda|