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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00988832
First received: October 1, 2009
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Crohn's Disease
Biological: Infliximab

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    Costs for all hospitalizations, including costs associated with elective

    and emergency (non-elective) admissions as well as outpatient procedures.


  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 380
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Biological: Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Other Names:
  • Remicade
  • SCH 215596

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00988832     History of Changes
Other Study ID Numbers: P06066
Study First Received: October 1, 2009
Results First Received: December 6, 2011
Last Updated: July 29, 2014
Health Authority: UK: National Research Ethics Service

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014