Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT01349920
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2011-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Moldova', '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', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, and on the presentation with regard to the following: proprietary information; the accuracy of the information; and that the presentation is fairly balanced and in compliance with FDA regulations.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)', 'description': 'All enrolled participants', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-study', 'description': 'From 4 weeks prior to first dose, up to first dose of infliximab', 'otherNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Infliximab 5mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Post-study', 'description': 'From last dose of study drug, up to 24 days after last dose of infliximab', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6", 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had a blinded CDEIS score at both baseline and at Week 6.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in CDEIS Blinded Score at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'spread': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 22', 'description': 'CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had a blinded CDEIS score at both baseline and at Week 22.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.1', 'spread': '30.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for hsCRP at both baseline and at Week 6.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum hsCRP at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.0', 'spread': '39.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for hsCRP at both baseline and at Week 22.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Stool Calprotectin at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '231.1', 'spread': '4099.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.', 'unitOfMeasure': 'µg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for calprotectin at both baseline and at Week 6.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Stool Calprotectin at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'spread': '3236.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.', 'unitOfMeasure': 'µg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for calprotectin at both baseline and at Week 22.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Lipocalin-2 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-103.7', 'spread': '108.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for lipocalin-2 at both baseline and at Week 6.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Lipocalin-2 at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-104.6', 'spread': '108.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for lipocalin-2 at both baseline and at Week 22.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.7', 'spread': '20.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for REG3-A at both baseline and at Week 6.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in REG3-A at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.2', 'spread': '30.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with measurements for REG3-A at both baseline and at Week 22.'}, {'type': 'PRIMARY', 'title': 'Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'title': 'Week 6 (n = 9)', 'categories': [{'measurements': [{'value': '0.920', 'groupId': 'OG000', 'lowerLimit': '0.458', 'upperLimit': '0.929'}]}]}, {'title': 'Week 22 (n = 10)', 'categories': [{'measurements': [{'value': '0.638', 'groupId': 'OG000', 'lowerLimit': '0.539', 'upperLimit': '0.946'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000'], 'groupDescription': 'Week 6', 'statisticalMethod': 'Multiple Linear Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.381', 'groupIds': ['OG000'], 'groupDescription': 'Week 22', 'statisticalMethod': 'Multiple Linear Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 6 or 22', 'description': 'To determine R\\^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R\\^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R\\^2 at weeks 6 and 22 is approximately 0.7.', 'unitOfMeasure': 'Coefficient of Determination', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had a blinded CDEIS score and measurements for each of the biomarkers included in the models at both baseline and at Week 6 or 22.'}, {'type': 'SECONDARY', 'title': 'Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'title': 'serum hsCRP (n=14)', 'categories': [{'measurements': [{'value': '0.954', 'groupId': 'OG000', 'lowerLimit': '0.913', 'upperLimit': '0.995'}]}]}, {'title': 'serum REG3-A (n=15)', 'categories': [{'measurements': [{'value': '0.974', 'groupId': 'OG000', 'lowerLimit': '0.952', 'upperLimit': '0.996'}]}]}, {'title': 'serum lipocalin-2 (n=15)', 'categories': [{'measurements': [{'value': '0.910', 'groupId': 'OG000', 'lowerLimit': '0.835', 'upperLimit': '0.986'}]}]}, {'title': 'stool calprotectin (n=15)', 'categories': [{'measurements': [{'value': '0.792', 'groupId': 'OG000', 'lowerLimit': '0.629', 'upperLimit': '0.954'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)', 'description': 'Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.', 'unitOfMeasure': 'Correlation coefficient', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both baseline serum or stool measurements available for analysis.'}, {'type': 'SECONDARY', 'title': 'Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab 5 mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'classes': [{'title': 'CDEIS Baseline (n = 15)', 'categories': [{'measurements': [{'value': '0.662', 'groupId': 'OG000', 'lowerLimit': '0.428', 'upperLimit': '0.896'}]}]}, {'title': 'CDEIS Week 6 (n = 13)', 'categories': [{'measurements': [{'value': '0.693', 'groupId': 'OG000', 'lowerLimit': '0.458', 'upperLimit': '0.929'}]}]}, {'title': 'CDEIS Week 22 (n = 12)', 'categories': [{'measurements': [{'value': '0.743', 'groupId': 'OG000', 'lowerLimit': '0.539', 'upperLimit': '0.946'}]}]}, {'title': 'SES-CD Baseline (n = 15)', 'categories': [{'measurements': [{'value': '0.453', 'groupId': 'OG000', 'lowerLimit': '0.176', 'upperLimit': '0.729'}]}]}, {'title': 'SES-CD Week 6 (n = 13)', 'categories': [{'measurements': [{'value': '0.937', 'groupId': 'OG000', 'lowerLimit': '0.879', 'upperLimit': '0.995'}]}]}, {'title': 'SES-CD Week 22 (n = 13)', 'categories': [{'measurements': [{'value': '0.753', 'groupId': 'OG000', 'lowerLimit': '0.562', 'upperLimit': '0.945'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6, Week 22', 'description': "The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.", 'unitOfMeasure': 'Correlation coefficient', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had both blinded and unblinded scores available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infliximab 5mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants 18 to 60 years of age, with moderate to severe Crohn's Disease (CD) who had not been previously treated with anti-inflammatory biologic agents were enrolled in this trial."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Infliximab 5mg/kg', 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool, serum, peripheral blood mononuclear cells (PBMC)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2011-05-05', 'resultsFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2011-05-06', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-04', 'studyFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6", 'timeFrame': 'Baseline and Week 6', 'description': 'CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.'}, {'measure': 'Change From Baseline in CDEIS Blinded Score at Week 22', 'timeFrame': 'Baseline and Week 22', 'description': 'CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.'}, {'measure': 'Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.'}, {'measure': 'Change From Baseline in Serum hsCRP at Week 22', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.'}, {'measure': 'Change From Baseline in Stool Calprotectin at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.'}, {'measure': 'Change From Baseline in Stool Calprotectin at Week 22', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.'}, {'measure': 'Change From Baseline in Serum Lipocalin-2 at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.'}, {'measure': 'Change From Baseline in Serum Lipocalin-2 at Week 22', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.'}, {'measure': 'Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.'}, {'measure': 'Change From Baseline in REG3-A at Week 22', 'timeFrame': 'Baseline and Week 22', 'description': 'Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.'}, {'measure': 'Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22', 'timeFrame': 'Baseline and Week 6 or 22', 'description': 'To determine R\\^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R\\^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R\\^2 at weeks 6 and 22 is approximately 0.7.'}], 'secondaryOutcomes': [{'measure': 'Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers', 'timeFrame': 'Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)', 'description': 'Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.'}, {'measure': 'Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation', 'timeFrame': 'Baseline, Week 6, Week 22', 'description': "The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biological markers', 'endoscopy', 'gastrointestinal'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': 'This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy with infliximab and determine whether changes in the levels of the selected biomarkers can be used to predict endoscopically assessed gut mucosal status changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Approximately 20 participants aged 18 to 60 years with Crohn's Disease will be enrolled from gastrointestinal specialist clinics.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time\n* History of colonic involvement verified by prior endoscopy or radiography\n* Indicated for treatment with infliximab according to current best medical practice\n* Body Mass Index (BMI) between 15 kg/m\\^2 and 35 kg/m\\^2\n* Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception\n* Negative pregnancy test\n* No signs or symptoms of active tuberculosis (TB) and has a negative TB test within 6 weeks of first study drug administration\n\nExclusion Criteria:\n\n* Pregnancy, intention to become pregnant, or breastfeeding\n* Evidence of a colon unaffected by CD\n* Indication for surgery\n* Perianal disease likely to interfere with study participation\n* Presence of a stoma or history of colectomy\n* Symptomatic diarrhea unrelated to CD\n* Strictures or evidence of bowel obstruction\n* Presence of abscess unless completed definitive treatment can be documented one week prior to screening\n* Presence of fistulas\n* Contraindication to infliximab\n* Intolerance to sedatives or other medications required for endoscopy\n* Any prior use of anti-inflammatory biologic therapy\n* Moderate or severe congestive heart failure\n* History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis\n* Major surgery or donation/loss of at least one unit of blood within 4 weeks of screening\n* Positive for hepatitis B surface antigen, hepatitis C antibodies, or Human Immunodeficiency Virus (HIV)\n* History of any tumor except adequately treated basal cell carcinoma or carcinoma in situ of the cervix\n* History of systemic granulomatous infection\n* History of nontuberculous mycobacterial disease, or any opportunistic infection within 12 months of study entry\n* Transplanted organ including bone marrow or hematopoietic stem cell-derived marrow"}, 'identificationModule': {'nctId': 'NCT01349920', 'briefTitle': "Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)", 'orgStudyIdInfo': {'id': 'P08143'}, 'secondaryIdInfos': [{'id': '2011-000517-40', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-2155-195'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infliximab 5 mg/kg', 'description': 'Infliximab treatment and endoscopy.', 'interventionNames': ['Drug: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['Remicade', 'SCH 215596', 'MK-2155'], 'description': 'Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.', 'armGroupLabels': ['Infliximab 5 mg/kg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}