An observational study in Crohn's Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-02.
Sponsored by Merck Sharp & Dohme LLC · Observational
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.
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 380 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Also known as: Remicade, SCH 215596
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.
| Milestone | Infliximab |
|---|---|
| Started | 380 |
| Completed | 380 |
| Not completed | 0 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant of Consultations With Health Care Providers (HCPs) | 913.48 ± 516.36 | 962.30 ± 547.89 | 1317.58 ± 730.45 | 1664.45 ± 910.45 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant of Elective Surgical Procedures | 752.46 ± 2162.95 | 572.75 ± 1846.60 | 818.46 ± 2167.24 | 1078.47 ± 2484.84 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions | 1107.65 ± 1979.67 | 769.95 ± 1831.80 | 1002.33 ± 2107.25 | 1261.42 ± 2347.89 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant for Admissions for Day Case Surgery | 48.73 ± 247.92 | 18.60 ± 159.00 | 33.16 ± 206.28 | 48.13 ± 260.52 |
Costs for all hospitalizations, including costs associated with elective and emergency (non-elective) admissions as well as outpatient procedures.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant for All Hospitalizations | 1908.85 ± 3092.15 | 1361.30 ± 2859.93 | 1853.95 ± 3364.42 | 2388.01 ± 3885.02 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant of Accident and Emergency (A&E) Visits | 3.01 ± 18.66 | 4.34 ± 24.24 | 6.60 ± 29.57 | 8.22 ± 35.22 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Excluding Biologics | 327.98 ± 362.36 | 431.78 ± 485.98 | 653.31 ± 727.71 | 879.05 ± 957.98 |
| Including adalimumab | 327.98 ± 362.36 | 615.23 ± 1163.99 | 1092.65 ± 2304.38 | 1678.72 ± 3630.93 |
| Including adalimumab and infliximab | 327.98 ± 362.36 | 9430.57 ± 4769.30 | 12644.40 ± 7138.18 | 15934.80 ± 9616.83 |
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.
| Pounds sterling per participant | 0-12 Months Pre-Infliximab | 0-12 Months Post-Infliximab | 0-18 Months Post-Infliximab | 0-24 Months Post-Infliximab |
|---|---|---|---|---|
| Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations | 411 ± 397.72 | 199.77 ± 374.94 | 303.94 ± 480.03 | 380.08 ± 535.19 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INFLIXIMAB, RECOMBINANT | — | 36/380 (9.5%) | 0/380 (0%) |
| Event | INFLIXIMAB, RECOMBINANT |
|---|---|
| INFUSION RELATED REACTIONInjury, poisoning and procedural complications | 8/380 |
| ANAPHYLACTIC REACTIONImmune system disorders | 3/380 |
| DRUG EXPOSURE DURING PREGNANCYInjury, poisoning and procedural complications | 3/380 |
| PALPITATIONSCardiac disorders | 2/380 |
| CROHN'S DISEASEGastrointestinal disorders | 2/380 |
| HYPERSENSITIVITYImmune system disorders | 2/380 |
| CELLULITISInfections and infestations | 2/380 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 2/380 |
| RECTAL CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/380 |
| HEADACHENervous system disorders | 2/380 |
| Age, Continuous(years) | Infliximab |
|---|---|
| Mean | 37 ± 13 |
| Sex/Gender, Customized(participants) | Infliximab |
|---|---|
| Female | 208 |
| Male | 171 |
| Not Specified | 1 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC