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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553176
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):
Janssen Biotech, Inc.

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.

Condition or disease Intervention/treatment
Crohn's Disease Other: No intervention

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.

Study Type : Observational
Actual Enrollment : 6273 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
Study Start Date : August 1999
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with Crohn's disease
The Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease
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

Primary Outcome Measures :
  1. To document the variety of treatment regimens currently employed in the management of Crohn's disease [ Time Frame: Five years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with Crohn's Disease

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553176

Sponsors and Collaborators
Janssen Biotech, Inc.
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.

Responsible Party: Janssen Biotech, Inc. Identifier: NCT00553176     History of Changes
Other Study ID Numbers: CR014140
WIRB® 990474 ( Other Identifier: Janssen Biotech, Inc. )
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by Janssen Biotech, Inc.:
Immune disorder
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases