An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Infliximab (Biological)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The aim of this study is to quantify how infliximab therapy is being used in the UK and the
consequent impact on health care resources, which will help to inform budget holders and
payers on the costs associated with the treatment of Crohn's Disease.
Clinical Details
Official title: A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab
Study design: Observational Model: Case-Only, Time Perspective: Retrospective
Primary outcome: Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)Mean Cost Per Participant of Elective Surgical Procedures Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions Mean Cost Per Participant for Admissions for Day Case Surgery Mean Cost Per Participant for All Hospitalizations Mean Cost Per Participant of Accident and Emergency (A&E) Visits Mean Cost Per Participant for Crohns-related Medications Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations
Detailed description:
All interested hospital physicians across the UK who prescribe infliximab as part of their
treatment of Crohn's Disease patients. will be included. It is assumed that the physician
population will consist primarily of gastroenterologists, though general physicians
(hospital-based) with an interest in Crohn's Disease may also be included.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of Crohn's Disease.
- Over the age of 18 years.
- Must have received the first infusion of infliximab on or after 1st January 2003
(when the maintenance therapy license was granted).
- Must have received at least one infusion of infliximab.
- A minimum of 12 months data prior to, and 24 months data post infliximab exposure
should be available in the medical records.
- Must have been under the care of the participating center for the entirety of the
study period.
Exclusion Criteria:
- Should not have been involved in any clinical trial during the observational period
(ie, a minimum of 12 months before and 24 months after first receiving infliximab).
- Should not have received any biologic therapy prior to infliximab.
Locations and Contacts
Additional Information
Starting date: February 2010
Last updated: June 8, 2015
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