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

Primary Purpose

Ulcerative Colitis, Crohn's Disease

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Measurement of drug (Adalimumab/Infliximab)

Intensify treatment with the existing drug

About this trial

This is an interventional health services research trial for Ulcerative Colitis focused on measuring Harvey Bradshaw score, Partial Mayo Clinical Score, Infliximab, Adalimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rocky Mountain Gastroenterology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Empiric Dose Intensification

Testing based strategy

Arm Description

Intensify treatment with the existing drug

Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The efficacy of the testing-based strategy compared to empiric dose intensification

The proportion of subjects achieving clinical remission

Full Information

NCT ID

NCT01960426

First Posted

September 25, 2013

Last Updated

May 12, 2016

Sponsor

University of Western Ontario, Canada

Collaborators

Prometheus Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01960426

Brief Title

Evaluation of Health Costs and Resource Utilization

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

recruitment issues

Study Start Date

April 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Western Ontario, Canada

Collaborators

Prometheus Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Crohn's Disease

Keywords

Harvey Bradshaw score, Partial Mayo Clinical Score, Infliximab, Adalimumab

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Empiric Dose Intensification

Arm Type

Active Comparator

Arm Description

Intensify treatment with the existing drug

Arm Title

Testing based strategy

Arm Type

Active Comparator

Arm Description

Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement

Intervention Type

Other

Intervention Name(s)

Measurement of drug (Adalimumab/Infliximab)

Intervention Description

Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.

Intervention Type

Other

Intervention Name(s)

Intensify treatment with the existing drug

Intervention Description

Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist

Primary Outcome Measure Information:

Title

the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms

Description

Analysis of costs and outcomes will be made on an intention-to-treat basis

Time Frame

31 weeks

Secondary Outcome Measure Information:

Title

The efficacy of the testing-based strategy compared to empiric dose intensification

Description

The proportion of subjects achieving clinical remission

Time Frame

31 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Feagan, MD

Organizational Affiliation

Robarts Clinical Trials Inc. - Western University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rocky Mountain Gastroenterology Associates

City

Denver

State/Province

Colorado

ZIP/Postal Code

80222

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23357488

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.

Results Reference

background

PubMed Identifier

15817555

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.

Results Reference

background

PubMed Identifier

16472588

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.

Results Reference

background

PubMed Identifier

17634458

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.

Results Reference

background

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Evaluation of Health Costs and Resource Utilization

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