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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00988832
Date of registration: 01/10/2009
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
Scientific title: A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab
Date of first enrolment: February 2010
Target sample size: 380
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00988832
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United Kingdom
Contacts
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Biological: Infliximab
Primary Outcome(s)
Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant for Admissions for Day Case Surgery [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant for All Hospitalizations [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant for Crohns-related Medications [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant of Accident and Emergency (A&E) Visits [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant of Consultations With Health Care Providers (HCPs) [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Mean Cost Per Participant of Elective Surgical Procedures [Time Frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab]
Secondary Outcome(s)
Secondary ID(s)
P06066
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 26/07/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00988832
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