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

Crohn's Disease Clinical Trial

— TREAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553176
• Other study ID #: CR014140
• Secondary ID: WIRB® 990474
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2007
• Last updated: March 1, 2013
• Start date: August 1999
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Janssen Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6273
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• No intervention
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Biotech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To document the variety of treatment regimens currently employed in the management of Crohn's disease		Five years	No
Secondary	To assess clinical, economic, and humanistic outcomes of treatment		Five years	No
Secondary	To assess the long-term impact of various Crohn's disease treatment regimens		Five years	No
Secondary	To assess long-term outcomes specifically associated with the use of Remicade		Five years	No
Secondary	Collection of adverse events		Five years	Yes