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Trial record 2 of 2 for:    17634458 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT01960426
Recruitment Status : Terminated (recruitment issues)
First Posted : October 10, 2013
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Disease Other: Measurement of drug (Adalimumab/Infliximab) Other: Intensify treatment with the existing drug Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
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 Start Date : April 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The efficacy of the testing-based strategy compared to empiric dose intensification [ Time Frame: 31 weeks ]
    The proportion of subjects achieving clinical remission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960426


Locations
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United States, Colorado
Rocky Mountain Gastroenterology Associates
Denver, Colorado, United States, 80222
Sponsors and Collaborators
University of Western Ontario, Canada
Prometheus Laboratories
Investigators
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Principal Investigator: Brian Feagan, MD Robarts Clinical Trials Inc. - Western University

Publications:
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Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01960426     History of Changes
Other Study ID Numbers: RP1208
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Western Ontario, Canada:
Harvey Bradshaw score
Partial Mayo Clinical Score
Infliximab
Adalimumab
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Adalimumab
Infliximab
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents