Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-29 @ 7:43 PM
Study NCT ID:
NCT00724958
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, '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': 'ClinicalTrialDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.", 'otherNumAtRisk': 343, 'otherNumAffected': 0, 'seriousNumAtRisk': 343, 'seriousNumAffected': 43}], 'seriousEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Colonic Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ileal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Small Intestinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cytokine Release Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Herpes Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Perirectal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Aspiration Bone Marrow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'B-cell Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chondrosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Colon Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cluster Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Simple Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abscess Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Colectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Enterostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Enterostomy Closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Intestinal Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'classes': [{'title': 'Interval between infusion 1 & 2, n=298', 'categories': [{'measurements': [{'value': '16.89', 'spread': '11.35', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 2 & 3, n=275', 'categories': [{'measurements': [{'value': '34.74', 'spread': '17.14', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 3 & 4, n=250', 'categories': [{'measurements': [{'value': '63.22', 'spread': '26.07', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 4 & 5, n=227', 'categories': [{'measurements': [{'value': '62.86', 'spread': '26.40', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 5 & 6, n=210', 'categories': [{'measurements': [{'value': '61.30', 'spread': '18.03', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 6 & 7, n=186', 'categories': [{'measurements': [{'value': '60.95', 'spread': '20.16', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 7 & 8, n=162', 'categories': [{'measurements': [{'value': '59.24', 'spread': '16.81', 'groupId': 'OG000'}]}]}, {'title': 'Interval between infusion 8 & 9, n=148', 'categories': [{'measurements': [{'value': '60.22', 'spread': '16.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of infliximab-naive participants'}, {'type': 'PRIMARY', 'title': 'Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'classes': [{'title': 'Interval between infusion 1 & 2, n=298', 'categories': [{'measurements': [{'value': '14.00', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '129'}]}]}, {'title': 'Interval between infusion 2 & 3, n=275', 'categories': [{'measurements': [{'value': '28.00', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '182'}]}]}, {'title': 'Interval between infusion 3 & 4, n=250', 'categories': [{'measurements': [{'value': '56.00', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '266'}]}]}, {'title': 'Interval between infusion 4 & 5, n=227', 'categories': [{'measurements': [{'value': '57.00', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '273'}]}]}, {'title': 'Interval between infusion 5 & 6, n=210', 'categories': [{'measurements': [{'value': '57.00', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '184'}]}]}, {'title': 'Interval between infusion 6 & 7, n=186', 'categories': [{'measurements': [{'value': '56.00', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '214'}]}]}, {'title': 'Interval between infusion 7 & 8, n=162', 'categories': [{'measurements': [{'value': '56.00', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '161'}]}]}, {'title': 'Interval between infusion 8 & 9, n=148', 'categories': [{'measurements': [{'value': '56.00', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of infliximab-naive participants'}, {'type': 'SECONDARY', 'title': 'Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'classes': [{'title': 'Infusion 1, n=44', 'categories': [{'measurements': [{'value': '8.25', 'spread': '5.60', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 2, n=28', 'categories': [{'measurements': [{'value': '3.46', 'spread': '3.69', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 3, n=19', 'categories': [{'measurements': [{'value': '2.21', 'spread': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 4, n=20', 'categories': [{'measurements': [{'value': '2.40', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 5, n=23', 'categories': [{'measurements': [{'value': '2.70', 'spread': '3.36', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 6, n=24', 'categories': [{'measurements': [{'value': '3.38', 'spread': '4.19', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 7, n=17', 'categories': [{'measurements': [{'value': '2.06', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 8, n=17', 'categories': [{'measurements': [{'value': '2.29', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 9, n=15', 'categories': [{'measurements': [{'value': '2.67', 'spread': '2.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; \\<5 (remission), 5-7 (mild disease), 8-16 (moderate disease), \\>16 (severe disease).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)'}, {'type': 'PRIMARY', 'title': 'Average Dose of Infliximab Per Participant Within the Observation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'classes': [{'title': 'Infusion 1, n=315', 'categories': [{'measurements': [{'value': '5.09', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 2, n=300', 'categories': [{'measurements': [{'value': '5.04', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 3, n=276', 'categories': [{'measurements': [{'value': '5.06', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 4, n=253', 'categories': [{'measurements': [{'value': '5.11', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 5, n=227', 'categories': [{'measurements': [{'value': '5.20', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 6, n=210', 'categories': [{'measurements': [{'value': '5.17', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 7, n=186', 'categories': [{'measurements': [{'value': '5.19', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 8, n=163', 'categories': [{'measurements': [{'value': '5.22', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Infusion 9, n=148', 'categories': [{'measurements': [{'value': '5.25', 'spread': '0.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of infliximab-naive participants'}, {'type': 'PRIMARY', 'title': 'Median Dose of Infliximab Per Participant Within the Observation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'classes': [{'title': 'Infusion 1, n=315', 'categories': [{'measurements': [{'value': '5.09', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '8.62'}]}]}, {'title': 'Infusion 2, n=300', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '2.31', 'upperLimit': '8.77'}]}]}, {'title': 'Infusion 3, n=276', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.19', 'upperLimit': '8.77'}]}]}, {'title': 'Infusion 4, n=253', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.66', 'upperLimit': '11.43'}]}]}, {'title': 'Infusion 5, n=227', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.64', 'upperLimit': '11.43'}]}]}, {'title': 'Infusion 6, n=210', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '11.36'}]}]}, {'title': 'Infusion 7, n=186', 'categories': [{'measurements': [{'value': '5.08', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '11.43'}]}]}, {'title': 'Infusion 8, n=163', 'categories': [{'measurements': [{'value': '5.10', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '11.11'}]}]}, {'title': 'Infusion 9, n=148', 'categories': [{'measurements': [{'value': '5.12', 'groupId': 'OG000', 'lowerLimit': '3.37', 'upperLimit': '9.84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'n = number of infliximab-naive participants'}, {'type': 'PRIMARY', 'title': 'Total Dose of Infliximab Per Participant Within the Observation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'classes': [{'categories': [{'measurements': [{'value': '2290.32', 'spread': '1096.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '348'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'Loss of Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'No Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Remission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'No documentation for end of therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Remicade', 'description': "Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.68', 'spread': '12.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '178', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '343', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 348}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-16', 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).'}, {'measure': 'Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).'}, {'measure': 'Average Dose of Infliximab Per Participant Within the Observation Period', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).'}, {'measure': 'Median Dose of Infliximab Per Participant Within the Observation Period', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).'}, {'measure': 'Total Dose of Infliximab Per Participant Within the Observation Period', 'timeFrame': 'up to 2 years', 'description': 'Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).'}], 'secondaryOutcomes': [{'measure': 'Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.', 'timeFrame': '5 years', 'description': 'HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; \\<5 (remission), 5-7 (mild disease), 8-16 (moderate disease), \\>16 (severe disease).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.", 'detailedDescription': 'This study population was chosen from a non-probability sample'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with active luminal and/or fistulizing CD who are treated with Remicade in the hospital and non-hospital setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with active luminal and/or fistulizing CD.\n\nExclusion Criteria:\n\n* Per summary of product characteristics.'}, 'identificationModule': {'nctId': 'NCT00724958', 'briefTitle': "Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension", 'orgStudyIdInfo': {'id': 'P04052'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remicade', 'description': 'Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting.', 'interventionNames': ['Biological: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Remicade', 'SCH 215596'], 'description': 'Not specified in the protocol.', 'armGroupLabels': ['Remicade']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centocor, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}