A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

Study Overview
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Brief Summary
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TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Official Title
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A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial. Have plans for future visits at the site for continued management of IBD. Exclusion Criteria: Inability to provide written informed consent/assent. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries). Prior total abdominal colectomy for UC or IBDU.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of Inflammatory Bowel Disease: Characteristics of IBD |  | Up to 5 years | 
| Natural history of Inflammatory Bowel Disease: Participant demographics |  | Up to 5 years | 
| Natural history of Inflammatory Bowel Disease: Treatment use |  | Up to 5 years | 
| Natural history of Inflammatory Bowel Disease: Treatment response |  | Up to 5 years | 
| Natural history of Inflammatory Bowel Disease: Disease progression |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic measures of mucosal healing |  | Up to 5 years | 
| Adverse event frequency and severity |  | Every 3 months for 5 years | 
| Timepoint of clinical response |  | Every 3 months for 5 years | 
| Timepoint of endoscopic response |  | Up to 5 years | 
| Reasons for treatment discontinuation |  | Up to 5 years | 
| Self-reported patient health measures: EQ-5D |  | Every 3 months for 5 years | 
| Self-reported patient health measures: PRO-2 for Crohn's Disease |  | Every 3 months for 5 years | 
| Self-reported patient health measures: PRO-2 for Ulcerative colitis |  | Every 3 months for 5 years | 
| Self-reported patient health measures: 2-question Adherence Measure |  | Every 3 months for 5 years | 
| Self-reported patient health measures: Manitoba IBD Index (MIBDI) |  | Every 3 months for 5 years | 
| Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI) |  | Every 3 months for 5 years | 
| Timepoint of endoscopic remission |  | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Ulcerative colitis, Indeterminate colitis, Digestive System Diseases