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Completed

NCT Number: NCT00553176

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. To document the variety of treatment regimens currently employed in the management of Crohn's disease

    Time frame: Five years

Secondary outcomes

  1. To assess clinical, economic, and humanistic outcomes of treatment

    Time frame: Five years

  2. To assess the long-term impact of various Crohn's disease treatment regimens

    Time frame: Five years

  3. To assess long-term outcomes specifically associated with the use of Remicade

    Time frame: Five years

  4. Collection of adverse events

    Time frame: Five years

Sponsors and collaborators

Lead sponsor

Janssen Biotech, Inc.

Industry

Registry information

Official study title

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

Acronym: TREAT

Important dates

Study start
1999
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2007
Registry last updated
Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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