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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00988832 |
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Date of registration:
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01/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
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Scientific title:
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A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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380 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00988832 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Biological: Infliximab
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Primary Outcome(s)
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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