Care Path for the Management of Ulcerative Colitis (CONSTRUCT)
|Ulcerative Colitis||Other: Enhanced treatment algorithm Other: Usual Care||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Cluster Randomized Controlled Trial of a Care-Path for the Management of Ulcerative Colitis|
- Proportion of patients in remission at the end of 12 months. [ Time Frame: 12 months ]Remission is defined as 1) a Mayo Clinic Score of ≤2 with rectal bleeding and stool frequency sub-scale scores of 0) with no use of corticosteroids, and 3) normalization of the subject's index inflammatory marker (c-reactive protein or calprotectin). The primary endpoint will be assessed at Month 12.
- Proportion of patients in remission over the course of the study [ Time Frame: 18 months ]The time in remission over the course of the study; occurrence of surgery or hospitalization for Ulcerative Colitis; occurrence of disease-related complications; health related QoL (Short-Form 36 questionnaire [SF-36] and EuroQoL instrument [EQ-5D]); and, subject
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||May 2016|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Enhanced treatment algorithm
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
Other: Enhanced treatment algorithm
Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.
Placebo Comparator: Usual Care
These subjects will be managed according to local treatment guidelines for the treatment of UC.
Other: Usual Care
usual step care practice
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882426
|Principal Investigator:||Brian G Feagan, MD||Robarts Clinical Trials Inc.|