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Care Path for the Management of Ulcerative Colitis — CONSTRUCT  

Ulcerative Colitis Clinical Trial

Official title:
A Cluster Randomized Controlled Trial of a Care-Path for the Management of Ulcerative Colitis

Clinical Trial Summary

Assess if standardized care-path that features objective evaluations of disease activity and time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.

Clinical Trial Description

Step-care based on symptomatic response remains the overwhelming algorithm of choice in clinical practice. Many subjects receive infliximab only as a last resort, when the subject is very ill and has failed repeated attempts of corticosteroid induction therapy. Although this situation is far from ideal, to change such entrenched physician behavior will require compelling evidence that Step-care results in inferior outcomes to earlier introduction of effective therapy.

Based on these considerations, we will perform a cluster randomization trial in which 40 gastroenterology practices will be randomly assigned to a treatment algorithm featuring the early use of combination therapy, treatment intensification guided by objective assessments of inflammation and the use of remission as a therapeutic goal or a conventional Step-care approach. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01882426
Study type Interventional
Source University of Western Ontario, Canada
Contact
Status Terminated
Phase Phase 4
Start date May 2014
Completion date May 2016
View Details
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