Evaluation of Health Costs and Resource Utilization

NCT01960426 | Terminated Phase 4

• 1 other identifier: RP1208
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  31 weeks

Study Arms (2)

Empiric Dose Intensification

ACTIVE COMPARATOR

Intensify treatment with the existing drug

Other: Intensify treatment with the existing drug

Testing based strategy

ACTIVE COMPARATOR

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)

Interventions

Measurement of drug (Adalimumab/Infliximab) OTHER

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

Testing based strategy

Intensify treatment with the existing drug OTHER

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

Empiric Dose Intensification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Western Ontario, Canada: lead
• Prometheus Laboratories: collaborator

Study Sites (1)

Rocky Mountain Gastroenterology Associates

Denver, Colorado, 80222, United States

Location

Related Publications (4)

• 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.

  PMID: 23357488 BACKGROUND

• 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.

  PMID: 15817555 BACKGROUND

• 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.

  PMID: 16472588 BACKGROUND

• 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.

  PMID: 17634458 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

Adalimumab; Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Brian Feagan, MD

  Robarts Clinical Trials Inc. - Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 10, 2013
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (1)