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

1 september 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

380

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Biologisch: Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Andere namen:
  • Remicade
  • SCH215596

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2010

Primaire voltooiing (Werkelijk)

1 december 2010

Studie voltooiing (Werkelijk)

1 december 2010

Studieregistratiedata

Eerst ingediend

1 oktober 2009

Eerst ingediend dat voldeed aan de QC-criteria

1 oktober 2009

Eerst geplaatst (Schatting)

2 oktober 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

2 september 2015

Laatste update ingediend die voldeed aan QC-criteria

1 september 2015

Laatst geverifieerd

1 september 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • P06066

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Locaties

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