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

NCT ID: NCT00988832

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

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.

Conditions

Crohn's Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Infliximab

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

Infliximab

Intervention Type: BIOLOGICAL

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

Interventions

Infliximab

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade; SCH 215596

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P06066

Identifier Type: -

Identifier Source: org_study_id