Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Crohn Disease

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00705471

P04204

Details and patient eligibility

About

A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are targeted to participate in the study, each site is expected to provide 30-40 patient charts with a target of 108 charts total.

Full description

This study population was chosen from a non-probability sample.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment with infliximab for fistulizing CD.
• Administration of at least one infliximab infusion >=12 months before the chart review.
• 18 years of age or over (men and women).

Exclusion criteria

• Subjects not followed for a full year after their first infusion of infliximab.
• Subjects not followed for a full year prior to their first infusion of infliximab.
• Subjects who had participated in clinical studies during the data collection timeframe.

Trial design

42 participants in 1 patient group

Infliximab

Description:

Because of the difficulty of finding subjects with exactly the same disease severity, information will be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use.

Treatment:

Biological: Infliximab