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Completed

NCT Number: NCT00988832

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infliximab

Biological

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

Other names: Remicade, SCH 215596

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2009
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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