- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988832
An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
September 1, 2015 updated by: Merck Sharp & Dohme LLC
A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
380
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All interested hospital physicians across the UK who prescribe infliximab as part of their treatment of Crohn's Disease patients will be included.
Physicians will record information from the medical records of patients who meet the inclusion criteria.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
|
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease.
Costs of outpatient consultations are based on the 2009 Unit Cost of Health and Social Care published by the Personal Social Service Research Unit.
Consultations with gastroenterologists, gastric/gastrointestinal surgeons, radiologists, nurses/Inflammatory Bowel Disease nurses, dieticians/nutrition specialists, psychologists/psychiatrists, pharmacists, and occupational therapists are included in the analysis.
|
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
|
Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease.
Costs of elective surgical procedures were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors.
Costs were analyzed for elective surgeries that required participants to be admitted into a hospital.
|
12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
|
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
|
Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease.
Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors.
Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.
|
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
|
Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease.
Costs of day case (outpatient) surgeries were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors.
Costs were analyzed for any surgeries that did not require the participant to stay overnight in the hospital.
|
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
|
Costs for all hospitalizations, including costs associated with elective and emergency (non-elective) admissions as well as outpatient procedures. |
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
|
Costs for visits to A&E without admission.
Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease as per the 2009 Healthcare Resource Group (HRG) descriptors.
|
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
|
Costs of biologics were calculated by multiplying the number of vials of drug used per participant by the 2009 British National Formulary (BNF) cost per vial.
Costs of other drugs with ≥10 prescriptions were calculated by multiplying the 2009 BNF daily cost of the standard/most-prescribed dose of the most-prescribed drug (reference drug) in each drug group (Anatomical Therapeutic Classification [ATC] Level 4) by the length of treatment.
Costs for drugs in drug groups with ≤9 prescriptions were calculated using the average cost of all Crohns medications multiplied by the length of treatment.
|
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
|
Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease.
Costs of diagnostic tests conducted during outpatient consultations were calculated as per the 2008-2009 NHS Reference Costs.
Costs for diagnostic tests during hospitalizations and A&E visits were incorporated into cost analyses for those categories and are not included here.
|
12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 1, 2009
First Posted (Estimate)
October 2, 2009
Study Record Updates
Last Update Posted (Estimate)
September 2, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P06066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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