NCT01960426

Evaluation of Health Costs and Resource Utilization

A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Western Ontario, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.

Detailed description

The purpose of this study is to evaluate the utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.

Conditions

• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
OTHER	Measurement of drug (Adalimumab/Infliximab)	Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.
OTHER	Intensify treatment with the existing drug	Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-10-10
• Last updated: 2016-05-13

Locations

1 site across 1 country: United States