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.
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
Enrollment
6,273
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
To document the variety of treatment regimens currently employed in the management of Crohn's disease
Time frame: Five years
To assess clinical, economic, and humanistic outcomes of treatment
Time frame: Five years
To assess the long-term impact of various Crohn's disease treatment regimens
Time frame: Five years
To assess long-term outcomes specifically associated with the use of Remicade
Time frame: Five years
Collection of adverse events
Time frame: Five years
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