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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00553176

Acronym

TREAT

Enrollment

6273

Registered

2007-11-05

Start date

1999-08-31

Completion date

2012-05-31

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Infliximab, Immune disorder, Remicade, Registry, Crohn's Disease

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.

Interventions

OTHERNo 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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026