The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry (TREAT)
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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 |
- 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 ]
- 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 |
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.
Contacts and Locations
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 June 17, 2013