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

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ClinicalTrials.gov Identifier: NCT00988832
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : July 26, 2012
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition Crohn's Disease
Intervention Biological: Infliximab
Enrollment 380
Recruitment Details No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.
Pre-assignment Details  
Arm/Group Title Infliximab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 380
Completed 380
Not Completed 0
Arm/Group Title Infliximab
Hide Arm/Group Description 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 Number of Baseline Participants 380
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 380 participants
37  (13)
[1]
Measure Description: Age at first infusion of infliximab
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 380 participants
Female 208
Male 171
Not Specified 1
1.Primary Outcome
Title Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
913.48  (516.36) 962.30  (547.89) 1317.58  (730.45) 1664.45  (910.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Mean Cost Per Participant of Elective Surgical Procedures
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
752.46  (2162.95) 572.75  (1846.60) 818.46  (2167.24) 1078.47  (2484.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
1107.65  (1979.67) 769.95  (1831.80) 1002.33  (2107.25) 1261.42  (2347.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Mean Cost Per Participant for Admissions for Day Case Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
48.73  (247.92) 18.60  (159.00) 33.16  (206.28) 48.13  (260.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0423
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Mean Cost Per Participant for All Hospitalizations
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
1908.85  (3092.15) 1361.30  (2859.93) 1853.95  (3364.42) 2388.01  (3885.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Mean Cost Per Participant of Accident and Emergency (A&E) Visits
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
3.01  (18.66) 4.34  (24.24) 6.60  (29.57) 8.22  (35.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Primary Outcome
Title Mean Cost Per Participant for Crohns-related Medications
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
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)
8.Primary Outcome
Title Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0-12 Months Pre-Infliximab 0-12 Months Post-Infliximab 0-18 Months Post-Infliximab 0-24 Months Post-Infliximab
Hide Arm/Group Description:
Data from the 12 months prior to participants' first infusions of infliximab
Data from the first 12 months following participants' first infusions of infliximab
Data from the first 18 months following participants' first infusions of infliximab
Data from the first 24 months following participants' first infusions of infliximab
Overall Number of Participants Analyzed 380 380 380 380
Mean (Standard Deviation)
Unit of Measure: Pounds sterling per participant
411  (397.72) 199.77  (374.94) 303.94  (480.03) 380.08  (535.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0-12 Months Pre-Infliximab, 0-12 Months Post-Infliximab, 0-18 Months Post-Infliximab, 0-24 Months Post-Infliximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INFLIXIMAB, RECOMBINANT
Hide Arm/Group Description 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.
All-Cause Mortality
INFLIXIMAB, RECOMBINANT
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
INFLIXIMAB, RECOMBINANT
Affected / at Risk (%) # Events
Total   36/380 (9.47%)    
Blood and lymphatic system disorders   
HAEMOLYTIC URAEMIC SYNDROME  1  1/380 (0.26%)  1
Cardiac disorders   
PALPITATIONS  1  2/380 (0.53%)  2
TACHYCARDIA  1  1/380 (0.26%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/380 (0.26%)  2
ANAL FISTULA  1  1/380 (0.26%)  1
CROHN'S DISEASE  1  2/380 (0.53%)  2
INTESTINAL OBSTRUCTION  1  1/380 (0.26%)  1
INTESTINAL PERFORATION  1  1/380 (0.26%)  1
General disorders   
CHEST DISCOMFORT  1  1/380 (0.26%)  1
FEELING HOT  1  1/380 (0.26%)  1
MALAISE  1  1/380 (0.26%)  1
Immune system disorders   
ANAPHYLACTIC REACTION  1  3/380 (0.79%)  3
DRUG HYPERSENSITIVITY  1  1/380 (0.26%)  1
HYPERSENSITIVITY  1  2/380 (0.53%)  2
Infections and infestations   
ANAL ABSCESS  1  1/380 (0.26%)  1
CELLULITIS  1  2/380 (0.53%)  2
LIVER ABSCESS  1  1/380 (0.26%)  1
MENINGITIS HERPES  1  1/380 (0.26%)  1
PULMONARY TUBERCULOSIS  1  1/380 (0.26%)  1
SEPSIS  1  1/380 (0.26%)  1
TRACHEOBRONCHITIS  1  1/380 (0.26%)  2
Injury, poisoning and procedural complications   
DRUG EXPOSURE DURING PREGNANCY  1  3/380 (0.79%)  3
DRUG EXPOSURE VIA BREAST MILK  1  1/380 (0.26%)  1
INFUSION RELATED REACTION  1  8/380 (2.11%)  8
INTENTIONAL OVERDOSE  1  1/380 (0.26%)  1
Investigations   
ANTINUCLEAR ANTIBODY POSITIVE  1  1/380 (0.26%)  1
HEART RATE INCREASED  1  1/380 (0.26%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/380 (0.53%)  2
SYSTEMIC LUPUS ERYTHEMATOSUS  1  1/380 (0.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA  1  1/380 (0.26%)  1
METASTASES TO LIVER  1  1/380 (0.26%)  1
PROSTATE CANCER METASTATIC  1  1/380 (0.26%)  1
RECTAL CANCER  1  2/380 (0.53%)  2
RENAL CANCER  1  1/380 (0.26%)  1
Nervous system disorders   
HEADACHE  1  2/380 (0.53%)  2
LOSS OF CONSCIOUSNESS  1  1/380 (0.26%)  1
MYELITIS TRANSVERSE  1  1/380 (0.26%)  1
Pregnancy, puerperium and perinatal conditions   
ABORTION SPONTANEOUS  1  1/380 (0.26%)  1
Psychiatric disorders   
MAJOR DEPRESSION  1  1/380 (0.26%)  1
Renal and urinary disorders   
RENAL FAILURE ACUTE  1  1/380 (0.26%)  1
Reproductive system and breast disorders   
CERVICAL DYSPLASIA  1  1/380 (0.26%)  1
Respiratory, thoracic and mediastinal disorders   
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/380 (0.26%)  1
COUGH  1  1/380 (0.26%)  1
DYSPNOEA  1  2/380 (0.53%)  2
Skin and subcutaneous tissue disorders   
CUTANEOUS LUPUS ERYTHEMATOSUS  1  1/380 (0.26%)  1
Surgical and medical procedures   
ABORTION INDUCED  1  1/380 (0.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
INFLIXIMAB, RECOMBINANT
Affected / at Risk (%) # Events
Total   0/380 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp and Dohme Corp
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00988832    
Other Study ID Numbers: P06066
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: December 6, 2011
Results First Posted: July 26, 2012
Last Update Posted: September 2, 2015