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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Infliximab as prescribed by a physician in normal practice for Crohn's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab as prescribed by a physician in normal practice for Crohn's disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab | Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at first infusion of infliximab |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INFLIXIMAB, RECOMBINANT | Infliximab as prescribed by a physician in normal practice for Crohn's disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMOLYTIC URAEMIC SYNDROME | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp and Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| 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 |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG001 |
| 0-12 Months Post-Infliximab |
Data from the first 12 months following participants' first infusions of infliximab |
| OG002 | 0-18 Months Post-Infliximab | Data from the first 18 months following participants' first infusions of infliximab |
| OG003 | 0-24 Months Post-Infliximab | Data from the first 24 months following participants' first infusions of infliximab |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Pounds sterling per participant | 12 months prior to and 12, 18, and 24 months after the first infusion of infliximab |
|
|
|
|
| 36 |
| 380 |
| 0 |
| 380 |
| PALPITATIONS | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| CHEST DISCOMFORT | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| FEELING HOT | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| LIVER ABSCESS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| MENINGITIS HERPES | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| TRACHEOBRONCHITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| DRUG EXPOSURE DURING PREGNANCY | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| DRUG EXPOSURE VIA BREAST MILK | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| ANTINUCLEAR ANTIBODY POSITIVE | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| HEART RATE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| PROSTATE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| MYELITIS TRANSVERSE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 14.0 | Systematic Assessment |
|
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| CERVICAL DYSPLASIA | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| CUTANEOUS LUPUS ERYTHEMATOSUS | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
The Sponsor recognises the right of the investigator to publish the study results. The investigator is asked to send a draft of the publication/abstract to the Sponsor 30 days in advance of submission in order to obtain approval prior to submission. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion, the contents of the publication will be discussed in order to find a solution which satisfies both parties.
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Including adalimumab |
|
| Including adalimumab and infliximab |
|