Clinical trial NCT00988832: An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
Official title: A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All interested hospital physicians across the UK who prescribe infliximab as part of their treatment of Crohn's Disease patients will be included. Physicians will record information from the medical records of patients who meet the inclusion criteria.

Brief 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.

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 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.

Primary outcomes:
measure: Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant of Elective Surgical Procedures
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant for Admissions for Day Case Surgery
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant for All Hospitalizations
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant of Accident and Emergency (A&E) Visits
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant for Crohns-related Medications
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
measure: Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations
timeFrame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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