Evaluation of Health Costs and Resource Utilization
Phase 4
Terminated
- Conditions
- Crohn's DiseaseUlcerative Colitis
- Interventions
- Other: Intensify treatment with the existing drugOther: Measurement of drug (Adalimumab/Infliximab)
- Registration Number
- NCT01960426
- Lead Sponsor
- University of Western Ontario, Canada
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empiric Dose Intensification Intensify treatment with the existing drug Intensify treatment with the existing drug Testing based strategy Measurement of drug (Adalimumab/Infliximab) Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement
- Primary Outcome Measures
Name Time Method the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms 31 weeks Analysis of costs and outcomes will be made on an intention-to-treat basis
- Secondary Outcome Measures
Name Time Method The efficacy of the testing-based strategy compared to empiric dose intensification 31 weeks The proportion of subjects achieving clinical remission
Trial Locations
- Locations (1)
Rocky Mountain Gastroenterology Associates
🇺🇸Denver, Colorado, United States