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

Crohn's Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

• NCT number: NCT00553176
• Study type: Observational
• Source: Janssen Biotech, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: August 1999
• Completion date: May 2012