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

1 septembre 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

380

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Biologique: Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
Autres noms:
  • Rémicade
  • SCH 215596

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Merck Sharp & Dohme LLC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2010

Achèvement primaire (Réel)

1 décembre 2010

Achèvement de l'étude (Réel)

1 décembre 2010

Dates d'inscription aux études

Première soumission

1 octobre 2009

Première soumission répondant aux critères de contrôle qualité

1 octobre 2009

Première publication (Estimation)

2 octobre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 septembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2015

Dernière vérification

1 septembre 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • P06066

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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