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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
51
Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.
Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist
Rocky Mountain Gastroenterology Associates
Denver, Colorado, United States
the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms
Analysis of costs and outcomes will be made on an intention-to-treat basis
Time frame: 31 weeks
The efficacy of the testing-based strategy compared to empiric dose intensification
The proportion of subjects achieving clinical remission
Time frame: 31 weeks
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