An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Crohn's Disease

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00988832

P06066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

380 participants in 1 patient group

Infliximab

Description:

Infliximab as prescribed by a physician in normal practice for Crohn's disease

Treatment:

Biological: Infliximab