Evaluation of Health Costs and Resource Utilization

Stopped early · Phase 4

Conditions studied: Ulcerative Colitis, Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01960426

Run by

University of Western Ontario, Canada

People needed

51

Starts

2014-04-01

Expected to finish

2015-05-01

Last updated by the study team

2016-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.