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TREAT: The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
This study is ongoing, but not recruiting participants.
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00553176
  Purpose

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.


Condition Phase
Crohn's Disease
Phase IV

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab Tumor Necrosis Factors
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

Further study details as provided by Centocor, Inc.:

Estimated Enrollment: 5000
Study Start Date: July 1999
Detailed Description:

The TREAT Registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The registry's target minimum enrollment is for 5000 patients. It's objective is to 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Crohn's Disease

Exclusion Criteria:

  • Patients participating in any clinical trials for Crohn's disease or other conditions
  • Patients who are unable to participate in the program for 2 years or more
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553176

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Study ID Numbers: CR014140
Study First Received: November 1, 2007
Last Updated: November 1, 2007
ClinicalTrials.gov Identifier: NCT00553176  
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
TNF-alpha
infliximab
long-term safety
Registry
Crohn's Disease

Study placed in the following topic categories:
Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on February 06, 2009