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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT00553176
First received: November 1, 2007
Last updated: March 1, 2013
Last verified: March 2013
  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 Intervention Phase
Crohn's Disease
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • To document the variety of treatment regimens currently employed in the management of Crohn's disease [ Time Frame: Five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess clinical, economic, and humanistic outcomes of treatment [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • To assess the long-term impact of various Crohn's disease treatment regimens [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • To assess long-term outcomes specifically associated with the use of Remicade [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • Collection of adverse events [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Enrollment: 6273
Study Start Date: August 1999
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients diagnosed with Crohn's Disease

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553176

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

No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT00553176     History of Changes
Other Study ID Numbers: CR014140, WIRB® 990474
Study First Received: November 1, 2007
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014