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

An observational study of Crohn's Disease, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn's Disease
What is being tested?: Infliximab
How many people: 380 participants
Where: No sites listed yet
Study dates: Feb 2010to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Crohn's Disease
Being tested: Infliximab
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InfliximabBiological
Also called Remicade, SCH 215596
Infliximab as prescribed by a physician in normal practice for Crohn's disease

Study groups in NCT00988832
Study group	Role	What they receive
Infliximab		Infliximab as prescribed by a physician in normal practice for Crohn's disease Receives: Biological: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Dec 2010

First posted2 Oct 2009 (estimated)
Study startFeb 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988832
Sponsor's protocol ID: P06066
Status last verified: Sep 2015
First submitted: 1 Oct 2009
Last updated: 2 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
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RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
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Ibd CAncer and seRious Infections in France (I-CARE 2)
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RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab
ClinicalTrials.gov ID: NCT00988832
Acronym / sponsor ID: P06066
Conditions: Crohn's Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 380 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Posted 26 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Infliximab	–	Biological: InfliximabInfliximab as prescribed by a physician in normal practice for Crohn's disease

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InfliximabAlso: Remicade, SCH 215596Infliximab as prescribed by a physician in normal practice for Crohn's disease	Biological	Infliximab

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 26 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infliximab	380	380

Primary outcome: 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. Mean (Standard Deviation). Unit: Pounds sterling per participant

Measure	0-12 Months Pre-Infliximab n = 380	0-12 Months Post-Infliximab n = 380	0-18 Months Post-Infliximab n = 380	0-24 Months Post-Infliximab n = 380
Value	913.48 (516.36)	962.30 (547.89)	1317.58 (730.45)	1664.45 (910.45)

0-12 Months Pre-Infliximab vs 0-12 Months Post-Infliximab vs 0-18 Months Post-Infliximab vs 0-24 Months Post-Infliximab: p <0.0001, ANOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: Pounds sterling per participant

Measure	0-12 Months Pre-Infliximab n = 380	0-12 Months Post-Infliximab n = 380	0-18 Months Post-Infliximab n = 380	0-24 Months Post-Infliximab n = 380
Value	752.46 (2162.95)	572.75 (1846.60)	818.46 (2167.24)	1078.47 (2484.84)

0-12 Months Pre-Infliximab vs 0-12 Months Post-Infliximab vs 0-18 Months Post-Infliximab vs 0-24 Months Post-Infliximab: p = 0.0004, ANOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: Pounds sterling per participant

Measure	0-12 Months Pre-Infliximab n = 380	0-12 Months Post-Infliximab n = 380	0-18 Months Post-Infliximab n = 380	0-24 Months Post-Infliximab n = 380
Value	1107.65 (1979.67)	769.95 (1831.80)	1002.33 (2107.25)	1261.42 (2347.89)

0-12 Months Pre-Infliximab vs 0-12 Months Post-Infliximab vs 0-18 Months Post-Infliximab vs 0-24 Months Post-Infliximab: p = 0.0041, ANOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: Pounds sterling per participant

Measure	0-12 Months Pre-Infliximab n = 380	0-12 Months Post-Infliximab n = 380	0-18 Months Post-Infliximab n = 380	0-24 Months Post-Infliximab n = 380
Value	48.73 (247.92)	18.60 (159.00)	33.16 (206.28)	48.13 (260.52)

0-12 Months Pre-Infliximab vs 0-12 Months Post-Infliximab vs 0-18 Months Post-Infliximab vs 0-24 Months Post-Infliximab: p = 0.0423, ANOVA

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INFLIXIMAB, RECOMBINANT	36 of 380 (9.5%)	0 of 380 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Crohn's Disease

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.