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

Completed

• Conditions: Crohn's Disease
• Interventions: Other: No intervention

• Registration Number: NCT00553176
• Lead Sponsor: Janssen Biotech, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2007-11-01
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6273

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Crohn's disease	No intervention	The Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease

Primary Outcome Measures

Name	Time	Method
To document the variety of treatment regimens currently employed in the management of Crohn's disease	Five years

Secondary Outcome Measures

Name	Time	Method
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