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

Crohn's Disease Clinical Trial

Official title:

A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988832
• Other study ID #: P06066
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: September 1, 2015
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: National Research Ethics Service
• Study type: Observational

Clinical Trial 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 associated with the treatment of Crohn's Disease.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)	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	No
Primary	Mean Cost Per Participant of Elective Surgical Procedures	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	No
Primary	Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions	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	No
Primary	Mean Cost Per Participant for Admissions for Day Case Surgery	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	No
Primary	Mean Cost Per Participant for All Hospitalizations	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	No
Primary	Mean Cost Per Participant of Accident and Emergency (A&E) Visits	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	No
Primary	Mean Cost Per Participant for Crohns-related Medications	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	No
Primary	Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations	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	No