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

NCT00988832 | Completed Results DMC

• 1 other identifier: P06066
• Study Type: observational
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Infliximab

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

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

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

Also known as: Remicade, SCH 215596

Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp and Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 2, 2015
• Results First Posted: July 26, 2012

Record last verified: 2015-09