Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Crohn's Disease

Eligibility:

All Genders

18+ years

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...

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 con...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2010

Estimated Enrollment :

380 Patients enrolled

Trial Details

Trial ID

NCT00988832

Start Date

February 1 2010

End Date

December 1 2010

Last Update

September 2 2015

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