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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease in Ontario.

Condition or disease
Crohn Disease Inflammatory Bowel Disease Perianal Fistula

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with CD with and without PAF will be observed retrospectively in this study.
Criteria

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 PAF 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 PAF case definition identified in Objective 1 in the selection period.
  3. Have to have 5 years of follow-up.

3.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 PAF 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Canada, Ontario
Takeda Canada Recruiting
Oakville, Ontario, Canada, L6H 0J8
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03981939     History of Changes
Other Study ID Numbers: IBD-5009
U1111-1233-6312 ( Other Identifier: World health organization )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Rectal Fistula
Fistula
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases