Evaluation of Health Costs and Resource Utilization

• Register: ClinicalTrials.gov
• Last refreshed on: 23 May 2016
• Main ID: NCT01960426
• Date of registration: 25/09/2013
• Prospective Registration: Yes
• Primary sponsor: University of Western Ontario, Canada
• Public title: Evaluation of Health Costs and Resource Utilization Test-NoTest
• Scientific 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.
• Date of first enrolment: April 2014
• Target sample size: 51
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01960426
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Brian Feagan, MD
• Affiliation: Robarts Clinical Trials Inc. - Western University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn's Disease

Intervention(s)

Other: Intensify treatment with the existing drug

Other: Measurement of drug (Adalimumab/Infliximab)

Primary Outcome(s)

the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms [Time Frame: 31 weeks]

Secondary Outcome(s)

The efficacy of the testing-based strategy compared to empiric dose intensification [Time Frame: 31 weeks]

Secondary ID(s)

RP1208

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Prometheus Laboratories