An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
2015년 9월 1일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
380
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Infliximab
Infliximab as prescribed by a physician in normal practice for Crohn's disease
|
Infliximab as prescribed by a physician in normal practice for Crohn's disease
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 2월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2010년 12월 1일
연구 등록 날짜
최초 제출
2009년 10월 1일
QC 기준을 충족하는 최초 제출
2009년 10월 1일
처음 게시됨 (추정)
2009년 10월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 9월 1일
마지막으로 확인됨
2015년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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