Evaluation of Health Costs and Resource Utilization (Test-NoTest)

May 12, 2016 updated by: University of Western Ontario, Canada

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80222
        • Rocky Mountain Gastroenterology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Empiric Dose Intensification
Intensify treatment with the existing drug
Other: Intensify treatment with the existing drug
Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist
Active Comparator: Testing based strategy
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)
Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.

What is the study measuring?

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
Time Frame: 31 weeks
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
Time Frame: 31 weeks
The proportion of subjects achieving clinical remission
31 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Western Ontario, Canada

Collaborators

Prometheus Laboratories

Investigators

  • Principal Investigator: Brian Feagan, MD, Robarts Clinical Trials Inc. - Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP1208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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