Evaluation of Health Costs and Resource Utilization

Ulcerative Colitis Clinical Trial

— Test-NoTest  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01960426
• Other study ID #: RP1208
• Status: Terminated
• Phase: Phase 4
• First received: September 25, 2013
• Last updated: May 12, 2016
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
United States	Rocky Mountain Gastroenterology Associates	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Prometheus Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (4)

Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The efficacy of the testing-based strategy compared to empiric dose intensification	The proportion of subjects achieving clinical remission	31 weeks	No