Clinical trial NCT01960426: Evaluation of Health Costs and Resource Utilization
Official title: A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Harvey Bradshaw score
Partial Mayo Clinical Score
Infliximab
Adalimumab
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
Collaborators: name: Prometheus Laboratories
First posted: 2013-10-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms
timeFrame: 31 weeks
Secondary outcomes:
measure: The efficacy of the testing-based strategy compared to empiric dose intensification
timeFrame: 31 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
Study officials:
affiliation: Robarts Clinical Trials Inc. - Western University
name: Brian Feagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.
citation: Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. doi: 10.1136/bmj.330.7495.843. No abstract available.
citation: Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, Panaccione R, Wolf D, Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33; quiz 591. doi: 10.1053/j.gastro.2005.11.030.
citation: Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):228-38. doi: 10.1056/NEJMoa067594.