Trial Outcomes & Findings for An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066) (NCT NCT00988832)
NCT ID: NCT00988832
Last Updated: 2015-09-02
Results Overview
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.
COMPLETED
380 participants
12 months prior to and 12, 18, and 24 months after the first infusion of infliximab
2015-09-02
Participant Flow
No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
380
|
|
Overall Study
COMPLETED
|
380
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
Baseline characteristics by cohort
| Measure |
Infliximab
n=380 Participants
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.
|
|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
208 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
171 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Specified
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)
|
913.48 Pounds sterling per participant
Standard Deviation 516.36
|
962.30 Pounds sterling per participant
Standard Deviation 547.89
|
1317.58 Pounds sterling per participant
Standard Deviation 730.45
|
1664.45 Pounds sterling per participant
Standard Deviation 910.45
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant of Elective Surgical Procedures
|
752.46 Pounds sterling per participant
Standard Deviation 2162.95
|
572.75 Pounds sterling per participant
Standard Deviation 1846.60
|
818.46 Pounds sterling per participant
Standard Deviation 2167.24
|
1078.47 Pounds sterling per participant
Standard Deviation 2484.84
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions
|
1107.65 Pounds sterling per participant
Standard Deviation 1979.67
|
769.95 Pounds sterling per participant
Standard Deviation 1831.80
|
1002.33 Pounds sterling per participant
Standard Deviation 2107.25
|
1261.42 Pounds sterling per participant
Standard Deviation 2347.89
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant for Admissions for Day Case Surgery
|
48.73 Pounds sterling per participant
Standard Deviation 247.92
|
18.60 Pounds sterling per participant
Standard Deviation 159.00
|
33.16 Pounds sterling per participant
Standard Deviation 206.28
|
48.13 Pounds sterling per participant
Standard Deviation 260.52
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts for all hospitalizations, including costs associated with elective and emergency (non-elective) admissions as well as outpatient procedures.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant for All Hospitalizations
|
1908.85 Pounds sterling per participant
Standard Deviation 3092.15
|
1361.30 Pounds sterling per participant
Standard Deviation 2859.93
|
1853.95 Pounds sterling per participant
Standard Deviation 3364.42
|
2388.01 Pounds sterling per participant
Standard Deviation 3885.02
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant of Accident and Emergency (A&E) Visits
|
3.01 Pounds sterling per participant
Standard Deviation 18.66
|
4.34 Pounds sterling per participant
Standard Deviation 24.24
|
6.60 Pounds sterling per participant
Standard Deviation 29.57
|
8.22 Pounds sterling per participant
Standard Deviation 35.22
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant for Crohns-related Medications
Including adalimumab and infliximab
|
327.98 Pounds sterling per participant
Standard Deviation 362.36
|
9430.57 Pounds sterling per participant
Standard Deviation 4769.30
|
12644.40 Pounds sterling per participant
Standard Deviation 7138.18
|
15934.80 Pounds sterling per participant
Standard Deviation 9616.83
|
|
Mean Cost Per Participant for Crohns-related Medications
Excluding Biologics
|
327.98 Pounds sterling per participant
Standard Deviation 362.36
|
431.78 Pounds sterling per participant
Standard Deviation 485.98
|
653.31 Pounds sterling per participant
Standard Deviation 727.71
|
879.05 Pounds sterling per participant
Standard Deviation 957.98
|
|
Mean Cost Per Participant for Crohns-related Medications
Including adalimumab
|
327.98 Pounds sterling per participant
Standard Deviation 362.36
|
615.23 Pounds sterling per participant
Standard Deviation 1163.99
|
1092.65 Pounds sterling per participant
Standard Deviation 2304.38
|
1678.72 Pounds sterling per participant
Standard Deviation 3630.93
|
PRIMARY outcome
Timeframe: 12 months prior to and 12, 18, and 24 months after the first infusion of infliximabCosts 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.
Outcome measures
| Measure |
0-12 Months Pre-Infliximab
n=380 Participants
Data from the 12 months prior to participants' first infusions of infliximab
|
0-12 Months Post-Infliximab
n=380 Participants
Data from the first 12 months following participants' first infusions of infliximab
|
0-18 Months Post-Infliximab
n=380 Participants
Data from the first 18 months following participants' first infusions of infliximab
|
0-24 Months Post-Infliximab
n=380 Participants
Data from the first 24 months following participants' first infusions of infliximab
|
|---|---|---|---|---|
|
Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations
|
411 Pounds sterling per participant
Standard Deviation 397.72
|
199.77 Pounds sterling per participant
Standard Deviation 374.94
|
303.94 Pounds sterling per participant
Standard Deviation 480.03
|
380.08 Pounds sterling per participant
Standard Deviation 535.19
|
Adverse Events
INFLIXIMAB, RECOMBINANT
Serious adverse events
| Measure |
INFLIXIMAB, RECOMBINANT
n=380 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
HAEMOLYTIC URAEMIC SYNDROME
|
0.26%
1/380 • Number of events 1
|
|
Cardiac disorders
PALPITATIONS
|
0.53%
2/380 • Number of events 2
|
|
Cardiac disorders
TACHYCARDIA
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.26%
1/380 • Number of events 2
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.53%
2/380 • Number of events 2
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.26%
1/380 • Number of events 1
|
|
General disorders
CHEST DISCOMFORT
|
0.26%
1/380 • Number of events 1
|
|
General disorders
FEELING HOT
|
0.26%
1/380 • Number of events 1
|
|
General disorders
MALAISE
|
0.26%
1/380 • Number of events 1
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.79%
3/380 • Number of events 3
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.26%
1/380 • Number of events 1
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.53%
2/380 • Number of events 2
|
|
Infections and infestations
ANAL ABSCESS
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
CELLULITIS
|
0.53%
2/380 • Number of events 2
|
|
Infections and infestations
LIVER ABSCESS
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
MENINGITIS HERPES
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
SEPSIS
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.26%
1/380 • Number of events 2
|
|
Injury, poisoning and procedural complications
DRUG EXPOSURE DURING PREGNANCY
|
0.79%
3/380 • Number of events 3
|
|
Injury, poisoning and procedural complications
DRUG EXPOSURE VIA BREAST MILK
|
0.26%
1/380 • Number of events 1
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
2.1%
8/380 • Number of events 8
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.26%
1/380 • Number of events 1
|
|
Investigations
ANTINUCLEAR ANTIBODY POSITIVE
|
0.26%
1/380 • Number of events 1
|
|
Investigations
HEART RATE INCREASED
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.53%
2/380 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.53%
2/380 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
0.53%
2/380 • Number of events 2
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
MYELITIS TRANSVERSE
|
0.26%
1/380 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.26%
1/380 • Number of events 1
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.26%
1/380 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.26%
1/380 • Number of events 1
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.53%
2/380 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
CUTANEOUS LUPUS ERYTHEMATOSUS
|
0.26%
1/380 • Number of events 1
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.26%
1/380 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp and Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER