Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-03-27 @ 5:23 PM
Study NCT ID:
NCT00988832
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2009-10-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp and Dohme Corp'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'INFLIXIMAB, RECOMBINANT', '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.", 'otherNumAtRisk': 380, 'otherNumAffected': 0, 'seriousNumAtRisk': 380, 'seriousNumAffected': 36}], 'seriousEvents': [{'term': 'HAEMOLYTIC URAEMIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ANAL FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "CROHN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'INTESTINAL PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'FEELING HOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ANAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'LIVER ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'MENINGITIS HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'PULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'TRACHEOBRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'DRUG EXPOSURE DURING PREGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'DRUG EXPOSURE VIA BREAST MILK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'INTENTIONAL OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ANTINUCLEAR ANTIBODY POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HEART RATE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'SYSTEMIC LUPUS ERYTHEMATOSUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'METASTASES TO LIVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'PROSTATE CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'RECTAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'RENAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'MYELITIS TRANSVERSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'CERVICAL DYSPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'CUTANEOUS LUPUS ERYTHEMATOSUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '913.48', 'spread': '516.36', 'groupId': 'OG000'}, {'value': '962.30', 'spread': '547.89', 'groupId': 'OG001'}, {'value': '1317.58', 'spread': '730.45', 'groupId': 'OG002'}, {'value': '1664.45', 'spread': '910.45', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.", 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant of Elective Surgical Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '752.46', 'spread': '2162.95', 'groupId': 'OG000'}, {'value': '572.75', 'spread': '1846.60', 'groupId': 'OG001'}, {'value': '818.46', 'spread': '2167.24', 'groupId': 'OG002'}, {'value': '1078.47', 'spread': '2484.84', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.", 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '1107.65', 'spread': '1979.67', 'groupId': 'OG000'}, {'value': '769.95', 'spread': '1831.80', 'groupId': 'OG001'}, {'value': '1002.33', 'spread': '2107.25', 'groupId': 'OG002'}, {'value': '1261.42', 'spread': '2347.89', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0041', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.", 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant for Admissions for Day Case Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '48.73', 'spread': '247.92', 'groupId': 'OG000'}, {'value': '18.60', 'spread': '159.00', 'groupId': 'OG001'}, {'value': '33.16', 'spread': '206.28', 'groupId': 'OG002'}, {'value': '48.13', 'spread': '260.52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0423', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.", 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant for All Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '1908.85', 'spread': '3092.15', 'groupId': 'OG000'}, {'value': '1361.30', 'spread': '2859.93', 'groupId': 'OG001'}, {'value': '1853.95', 'spread': '3364.42', 'groupId': 'OG002'}, {'value': '2388.01', 'spread': '3885.02', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', 'description': 'Costs for all hospitalizations, including costs associated with elective\n\nand emergency (non-elective) admissions as well as outpatient procedures.', 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant of Accident and Emergency (A&E) Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'spread': '18.66', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '24.24', 'groupId': 'OG001'}, {'value': '6.60', 'spread': '29.57', 'groupId': 'OG002'}, {'value': '8.22', 'spread': '35.22', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.", 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant for Crohns-related Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'title': 'Excluding Biologics', 'categories': [{'measurements': [{'value': '327.98', 'spread': '362.36', 'groupId': 'OG000'}, {'value': '431.78', 'spread': '485.98', 'groupId': 'OG001'}, {'value': '653.31', 'spread': '727.71', 'groupId': 'OG002'}, {'value': '879.05', 'spread': '957.98', 'groupId': 'OG003'}]}]}, {'title': 'Including adalimumab', 'categories': [{'measurements': [{'value': '327.98', 'spread': '362.36', 'groupId': 'OG000'}, {'value': '615.23', 'spread': '1163.99', 'groupId': 'OG001'}, {'value': '1092.65', 'spread': '2304.38', 'groupId': 'OG002'}, {'value': '1678.72', 'spread': '3630.93', 'groupId': 'OG003'}]}]}, {'title': 'Including adalimumab and infliximab', 'categories': [{'measurements': [{'value': '327.98', 'spread': '362.36', 'groupId': 'OG000'}, {'value': '9430.57', 'spread': '4769.30', 'groupId': 'OG001'}, {'value': '12644.40', 'spread': '7138.18', 'groupId': 'OG002'}, {'value': '15934.80', 'spread': '9616.83', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.', 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '380', 'groupId': 'OG002'}, {'value': '380', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0-12 Months Pre-Infliximab', 'description': "Data from the 12 months prior to participants' first infusions of infliximab"}, {'id': 'OG001', 'title': '0-12 Months Post-Infliximab', 'description': "Data from the first 12 months following participants' first infusions of infliximab"}, {'id': 'OG002', 'title': '0-18 Months Post-Infliximab', 'description': "Data from the first 18 months following participants' first infusions of infliximab"}, {'id': 'OG003', 'title': '0-24 Months Post-Infliximab', 'description': "Data from the first 24 months following participants' first infusions of infliximab"}], 'classes': [{'categories': [{'measurements': [{'value': '411', 'spread': '397.72', 'groupId': 'OG000'}, {'value': '199.77', 'spread': '374.94', 'groupId': 'OG001'}, {'value': '303.94', 'spread': '480.03', 'groupId': 'OG002'}, {'value': '380.08', 'spread': '535.19', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.", 'unitOfMeasure': 'Pounds sterling per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infliximab', '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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '380'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '380'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'No subjects were recruited for this retrospective study; participating investigators reviewed medical records of qualifying subjects and provided data to the sponsor.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Infliximab', '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."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age at first infusion of infliximab', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '208', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}, {'title': 'Not Specified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2009-10-01', 'resultsFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-19', 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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."}, {'measure': 'Mean Cost Per Participant of Elective Surgical Procedures', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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."}, {'measure': 'Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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."}, {'measure': 'Mean Cost Per Participant for Admissions for Day Case Surgery', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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."}, {'measure': 'Mean Cost Per Participant for All Hospitalizations', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', 'description': 'Costs for all hospitalizations, including costs associated with elective\n\nand emergency (non-elective) admissions as well as outpatient procedures.'}, {'measure': 'Mean Cost Per Participant of Accident and Emergency (A&E) Visits', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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."}, {'measure': 'Mean Cost Per Participant for Crohns-related Medications', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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.'}, {'measure': 'Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations', 'timeFrame': '12 months prior to and 12, 18, and 24 months after the first infusion of infliximab', '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."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Crohn's Disease.\n* Over the age of 18 years.\n* Must have received the first infusion of infliximab on or after 1st January 2003 (when the maintenance therapy license was granted).\n* Must have received at least one infusion of infliximab.\n* A minimum of 12 months data prior to, and 24 months data post infliximab exposure should be available in the medical records.\n* Must have been under the care of the participating center for the entirety of the study period.\n\nExclusion Criteria:\n\n* 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).\n* Should not have received any biologic therapy prior to infliximab."}, 'identificationModule': {'nctId': 'NCT00988832', 'briefTitle': "An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab", 'orgStudyIdInfo': {'id': 'P06066'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infliximab', 'description': "Infliximab as prescribed by a physician in normal practice for Crohn's disease", 'interventionNames': ['Biological: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Remicade', 'SCH 215596'], 'description': "Infliximab as prescribed by a physician in normal practice for Crohn's disease", 'armGroupLabels': ['Infliximab']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}