The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.

Detailed Description
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The TREAT (The Crohn's Therapy, Resource, Evaluation, and Assessment Tool) registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The physicians will track treatments and patient outcomes over at least a 5-year period. Physicians are expected to manage patients as they would under normal practice conditions. No predefined schedule of visits or medical procedures are required. Data are collected on a semi-annual basis by physicians documenting assessment of disease severity, medication use, and adverse events. Upon enrollment, patients complete a health assessment questionnaire. As this is an observational study, no study drugs are administered. Through the course of the Registry, analyses will be performed to support submissions to health authorities, and questions of academic interest.

Official Title
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Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

Conditions
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Crohn's Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be diagnosed with Crohn's Disease Exclusion Criteria: Patients participating in clinical trials for Crohn's disease or other conditions also were not eligible to be enrolled in the TREAT™ Registry Patients who are unable to participate in the program for 2 years or more.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Crohn's disease<br>The Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease | Other: No intervention<br>* At six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To document the variety of treatment regimens currently employed in the management of Crohn's disease |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess clinical, economic, and humanistic outcomes of treatment |  | Five years | 
| To assess the long-term impact of various Crohn's disease treatment regimens |  | Five years | 
| To assess long-term outcomes specifically associated with the use of Remicade |  | Five years | 
| Collection of adverse events |  | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infliximab, Immune disorder, Remicade, Registry, Crohn's Disease