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

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

Crohn's Disease

Treatments

Other: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT00553176
WIRB® 990474 (Other Identifier)
CR014140

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,273 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

6,273 participants in 1 patient group

Patients with Crohn's disease
Description:
The Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease
Treatment:
Other: No intervention

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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