Inflammatory Bowel DiseaseNCT03981939

Perianal Fistula (PAF) Validation and Burden of Illness Study

An observational study of Inflammatory Bowel Disease and Perianal Fistula, run by Takeda at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 105 years
Conditions the study is for: Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
How many people: 3,032 participants
Where: 1 siteCanada
Study dates: 2 Jul 2019to 31 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 105 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.
Participants were incident in the OCCC from April 1, 2002 to March 31, 2012.

Show all 12Show fewer

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 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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Takeda Canada
Oakville, Ontario, L6H 0J8

Other trials in Canada

About this study

Official title: Perianal Fistula Procedure Validation, Matched Case Control, and Patient Journey Study

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.

Read the detailed description

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:

CD Participants with/without CPAF (ICES data)
CD Participants with CPAF - The Ottawa Hospital (TOH)

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.

Conditions: Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
Being tested: No intervention
Keywords: Drug therapy
Medical subject headings: Inflammatory Bowel Diseases, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.

Study groups in NCT03981939
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the index date up to 5 years post-index

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201931 Dec 2019

First posted11 Jun 2019
Study start2 Jul 2019
Primary completion17 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 3,032 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03981939
Sponsor's protocol ID: IBD-5009
Other IDs: U1111-1233-6312
Status last verified: Mar 2021
First submitted: 7 Jun 2019
Last updated: 21 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Perianal Fistula Procedure Validation, Matched Case Control, and Patient Journey Study
ClinicalTrials.gov ID: NCT03981939
Acronym / sponsor ID: IBD-5009
Conditions: Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
Keywords: Drug therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,032 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 2 Jul 2019 (actual)
Primary completion: 17 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 11 Jun 2019 (actual)
Results: Posted 21 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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:

CD Participants with/without CPAF (ICES data)
CD Participants with CPAF - The Ottawa Hospital (TOH)

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
CD Participants with CPAF - The Ottawa Hospital (TOH)	–	Other: No interventionParticipants 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).
CD Participants without CPAF (ICES database)	–	Other: No interventionParticipants 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)	–	Other: No interventionParticipants 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).

Who may qualify

Ages: 18 to 105 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants diagnosed with CD with and without CPAF will be observed retrospectively in this study.

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionThis is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.	Other	CD Participants with CPAF (ICES database), CD Participants with CPAF - The Ottawa Hospital (TOH), CD Participants without CPAF (ICES database)

Primary outcome

Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database
Time frame: From the date of CD diagnosis up to the index date (approximately 5 years)
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.
Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF
Time frame: From the index date up to end of study (approximately 5 years post-index)
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.
Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database
Time frame: From the index date up to end of study (approximately 5 years post-index)
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.
Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database
Time frame: From the index date up to 5 years post-index
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.
Objective 3: Number of Visits for Healthcare Resource Utilization Based on Three Procedures for Crohn's Disease Participants With CPAF
Time frame: From the index date up to 5 years post-index
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.

Results and safety

Results posted to the registry on 21 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CD Participants With CPAF - The Ottawa Hospital (TOH)	549	549
CD Participants Without CPAF (ICES Database)	1,902	1,902
CD Participants With CPAF (ICES Database)	581	581

Primary outcome: Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database

Time frame: From the date of CD diagnosis up to the index date (approximately 5 years). Count of participants. Unit: Participants

Measure	CD Participants With CPAF - TOH n = 549
Any 2 Diagnosis/IC, in a 2 Year Period of Each Other	120
Any 3 Diagnosis/ IC/ Intervention Code/EUA+seton	120
Any 3 Diagnosis/ IC/ Intervention/EUA+seton, Diagnosis/ IC Requirements are Satisfied	127
Any 2 Diagnosis/ IC	127
Any 3 Diagnosis/ IC, 3 Codes Must be in 2 Year Period of Each Other	88
Any 3 Diagnosis/ IC	97
Any Diagnosis/ IC + (EUA+ Seton)	83
Any Diagnosis/ IC + (EUA+Seton), in a 2 Year Period of Each Other	78

Population analysed: All participants identified from TOH with and without CPAF were included in the analysis. Participants could meet more than more case definition.

Primary outcome: Objective 2: Mean Costs for Crohn's Disease Participants With and Without CPAF in ICES Database CPAF

Time frame: From the index date up to end of study (approximately 5 years post-index). Mean (Standard Deviation). Unit: canadian dollars

Measure	CD Participants Without CPAF (ICES Database) n = 1902	CD Participants With CPAF (ICES Database) n = 581
Total Cost	32781.12 (52124.77)	62375.54 (70332.9)
Total Cost (Without ODB)	22866.85 (37256.27)	36486.07 (42218.43)
Cost by Sector: General Physicians (GP)	1192.63 (2936.3)	1275.58 (1974.01)
Cost by Sector: Specialist	5978.09 (5317.74)	8075.60 (5777.89)
Cost by Sector: All physician OHIP	8029.55 (6818.29)	10368.04 (6969.59)
Cost by Sector: Home Care Services	900.90 (14925.27)	4142.01 (12246.05)
Cost by Sector: Hospital Admissions	7586.89 (23760.92)	11079.55 (24994.66)
Cost by Sector: Dialysis, Cancer, and Radiation	64.61 (949.45)	275.93 (4181.82)

Population analysed: 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.

Primary outcome: Objective 2: Number of Visits for Healthcare Resource Utilization for Crohn's Disease Participants With and Without CPAF in ICES Database

Time frame: From the index date up to end of study (approximately 5 years post-index). Mean (Standard Deviation). Unit: visits

Measure	CD Participants Without CPAF (ICES Database) n = 1902	CD Participants With CPAF (ICES Database) n = 581
Number of ED Visits	4.26 (6.28)	5.57 (8.09)
Number of Hospitalizations	0.95 (1.74)	1.38 (2.00)
Number of Outpatient Visits	8.57 (9.81)	15.18 (14.07)

Population analysed: 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.

Primary outcome: Objective 3: Mean Costs Based on Three Procedures for Crohn's Disease Participants With CPAF by Sector in ICES Database

Time frame: From the index date up to 5 years post-index. Mean (Standard Deviation). Unit: canadian dollars

Measure	No Intervention n = 237	Exam Under Anesthesia (EUA) ± Seton Only n = 307	Advanced Intervention n = 37
Total Cost	45982.45 (51581.52)	65430.16 (68268.35)	142034.86 (119455.5)
Total Cost (Without ODB)	26799.65 (26777.44)	36992.93 (33981.36)	94326 (100709.22)
Cost by Sector: GP	1144.88 (1762.59)	1218.24 (1583.95)	2588.51 (4379.07)
Cost by Sector: Specialist	7128.15 (5772.59)	8019.46 (4884.16)	14610.30 (8173.77)
Cost by Sector: All physician OHIP	9293.98 (6771.63)	10240.95 (5951.3)	18302.27 (10416.85)
Cost by Sector: Home Care Services	1231.69 (3596.56)	5217.44 (14078.41)	13860.7 (21997.79)
Cost by Sector: Hospital Admissions	7615.50 (14938.04)	9623.01 (18429.69)	45353.59 (66413.97)
Cost by Sector: Dialysis, Cancer, and Radiation	212.03 (2312.88)	350.46 (5383.99)	66.78 (406.23)

Population analysed: All participants who were eligible as cases (CD Participants with CPAF) CPAF from the ICES database were included in the analysis.

Adverse events

Time frame: Approximately 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CD Participants With CPAF - The Ottawa Hospital (TOH)	0 of 0	0 of 0	0 of 549
CD Participants Without CPAF (ICES Database)	0 of 0	0 of 0	0 of 1,902
CD Participants With CPAF (ICES Database)	0 of 0	0 of 0	0 of 581

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Disease and Perianal Fistula, run by Takeda at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective 1: Number of CD Participants Who Have CPAF Using Various Codes in an TOH Database (time frame: From the date of CD diagnosis up to the index date (approximately 5 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03981939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.