Evaluation of Health Costs and Resource Utilization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ulcerative Colitis, Crohn's Disease

Intervention / Treatment
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* Other: Measurement of drug (Adalimumab/Infliximab)
* Other: Intensify treatment with the existing drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males 18 years of age or older who are not receiving azathioprine or 6 mercaptopurine. Non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. [defined as a minimum of one year since the last menstrual period]). Documented diagnosis of CD or UC. Active disease symptoms at visit 1 defined by: a. CD subjects: HBS   6 UC subjects: PMCS   4. Current infliximab therapy (naive to adalimumab) or current adalimumab therapy (naive to infliximab ). A minimum of 13 weeks of infliximab or adalimumab treatment prior to visit 1 at the following dose: Stable dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1. Exclusion Criteria: Contraindication to the use of either infliximab or adalimumab. Current infliximab treatment but not naive to adalimumab or Current adalimumab treatment but not naive to infliximab. Infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w. Adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w. Received any investigational drug within 30 days prior to visit 1. Serious underlying disease other than CD or UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study. History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures. Stools positive for clostridium difficile. Pregnant or lactating women. Change in dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1. Males 22 years of age or less who are receiving azathioprine or 6 mercaptopurine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Empiric Dose Intensification<br>Intensify treatment with the existing drug | Other: Intensify treatment with the existing drug<br>* Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist<br>|
| Active Comparator: Testing based strategy<br>Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement | Other: Measurement of drug (Adalimumab/Infliximab)<br>* Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 31 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of the testing-based strategy compared to empiric dose intensification | The proportion of subjects achieving clinical remission | 31 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Harvey Bradshaw score, Partial Mayo Clinical Score, Infliximab, Adalimumab