Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-28 @ 9:29 AM
Study NCT ID:
NCT00805766
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2008-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Entire Evaluation Period', 'description': 'Screening Period + Increased Dose Period', 'otherNumAtRisk': 45, 'otherNumAffected': 37, 'seriousNumAtRisk': 45, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Screening Period', 'otherNumAtRisk': 45, 'otherNumAffected': 25, 'seriousNumAtRisk': 45, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Increased Dose Period', 'otherNumAtRisk': 39, 'otherNumAffected': 29, 'seriousNumAtRisk': 39, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Anal fistula infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Chest X-ray abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Polymorphic light eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}, {'term': 'Chronic inflammatory demyelinating polyradiculoneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA/J ver. 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TA-650'}], 'classes': [{'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '70.0', 'upperLimit': '134.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Increased Dose Period (Week 0 to Week 8)', 'description': "To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CDAI at Each Evaluation Time Point in the Increased Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TA-650'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '296.5', 'groupId': 'OG000', 'lowerLimit': '185', 'upperLimit': '523'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119.0', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '318'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '194.0', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '456'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '126.0', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '419'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '182.0', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '398'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '121.0', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '304'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '197.5', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '379'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '289'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '163.0', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '410'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '141.0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '315'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '148.5', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '407'}]}]}, {'title': 'Week 40 (the last time point)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '210.5', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '479'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Increased Dose Period (every 4 weeks for up to 40 weeks)', 'description': "CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.'}, {'type': 'SECONDARY', 'title': 'CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TA-650'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '75.2'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000', 'lowerLimit': '22.9', 'upperLimit': '57.9'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '85.3'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '50.8'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '76.5'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '48.7'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '78.5'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '57.6'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000', 'lowerLimit': '38.8', 'upperLimit': '77.6'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '70.1'}]}]}, {'title': 'Week 40 (the last time point)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '57.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Increased Dose Period (every 4 weeks for up to 40 weeks)', 'description': "CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.'}, {'type': 'SECONDARY', 'title': 'CDAI Change at Each Evaluation Time Point in the Increased Dose Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TA-650'}], 'classes': [{'title': 'Week 0 to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '163.0', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '356'}]}]}, {'title': 'Week 0 to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '-26', 'upperLimit': '301'}]}]}, {'title': 'Week 0 to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '161.0', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '342'}]}]}, {'title': 'Week 0 to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '-36', 'upperLimit': '240'}]}]}, {'title': 'Week 0 to Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '164.0', 'groupId': 'OG000', 'lowerLimit': '-63', 'upperLimit': '343'}]}]}, {'title': 'Week 0 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '-21', 'upperLimit': '252'}]}]}, {'title': 'Week 0 to Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '156.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '352'}]}]}, {'title': 'Week 0 to Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110.0', 'groupId': 'OG000', 'lowerLimit': '-28', 'upperLimit': '279'}]}]}, {'title': 'Week 0 to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.0', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '359'}]}]}, {'title': 'Week 0 to Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '-54', 'upperLimit': '390'}]}]}, {'title': 'Week 0 to 40(last measurable time point)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '-63', 'upperLimit': '390'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Increased Dose Period (every 4 weeks for up to 40 weeks)', 'description': "To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of TA-650 at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TA-650'}], 'classes': [{'title': 'Screening Period (SP), Week 0 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.12', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '13.29'}]}]}, {'title': 'SP, 1 hr after treatment end for week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.74', 'groupId': 'OG000', 'lowerLimit': '42.98', 'upperLimit': '132.99'}]}]}, {'title': 'SP, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.93', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '27.70'}]}]}, {'title': 'SP, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '10.69'}]}]}, {'title': 'SP, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.25', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '10.49'}]}]}, {'title': 'SP, Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.57'}]}]}, {'title': 'Increased dose Period(IP), Week0 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '10.69'}]}]}, {'title': 'IP, 1 hr after treatment end for week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '191.24', 'groupId': 'OG000', 'lowerLimit': '144.56', 'upperLimit': '293.32'}]}]}, {'title': 'IP, Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.93', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '43.55'}]}]}, {'title': 'IP, Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.29', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '21.82'}]}]}, {'title': 'IP, Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.20', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '48.30'}]}]}, {'title': 'IP, Week 16 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '23.67'}]}]}, {'title': 'IP, 1hr after administration at week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '203.16', 'groupId': 'OG000', 'lowerLimit': '140.33', 'upperLimit': '306.48'}]}]}, {'title': 'IP, Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.71', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '44.62'}]}]}, {'title': 'IP, Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.83', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '25.84'}]}]}, {'title': 'IP, Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.97', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '43.55'}]}]}, {'title': 'IP, Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '23.11'}]}]}, {'title': 'IP, Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.72', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '54.37'}]}]}, {'title': 'IP, Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '22.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.'}, {'type': 'SECONDARY', 'title': 'Antibody to TA-650 Determination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Period'}, {'id': 'OG001', 'title': 'Increased Dose Period'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Inconclusive', 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000'}, {'value': '76.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TA-650', 'description': 'Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.\n\nIncreased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal.'}], 'periods': [{'title': 'Screening Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Responder', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Increased Dose Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TA-650'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '7.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Screening period:', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Screening period:', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2008-12-09', 'resultsFirstSubmitDate': '2012-09-02', 'studyFirstSubmitQcDate': '2008-12-09', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-07', 'studyFirstPostDateStruct': {'date': '2008-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period", 'timeFrame': 'Increased Dose Period (Week 0 to Week 8)', 'description': "To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points."}], 'secondaryOutcomes': [{'measure': 'CDAI at Each Evaluation Time Point in the Increased Dose Period', 'timeFrame': 'Increased Dose Period (every 4 weeks for up to 40 weeks)', 'description': "CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points."}, {'measure': 'CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period', 'timeFrame': 'Increased Dose Period (every 4 weeks for up to 40 weeks)', 'description': "CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points."}, {'measure': 'CDAI Change at Each Evaluation Time Point in the Increased Dose Period', 'timeFrame': 'Increased Dose Period (every 4 weeks for up to 40 weeks)', 'description': "To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \\< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \\> 450 points."}, {'measure': 'Serum Concentration of TA-650 at Each Time Point', 'timeFrame': 'Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks'}, {'measure': 'Antibody to TA-650 Determination', 'timeFrame': 'Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infliximab', 'REMICADE', "Crohn's disease"], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Crohn's disease\n* Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician\n\nExclusion Criteria:\n\n* Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery\n* The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed\n* A history of a serious infusion reaction to REMICADE\n* Pregnant, lactating, and probably pregnant women\n* Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent\n* Patients judged to be inadequate to participate in this study by their physician"}, 'identificationModule': {'nctId': 'NCT00805766', 'briefTitle': "Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': "Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)", 'orgStudyIdInfo': {'id': 'TA-650-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA-650', 'interventionNames': ['Drug: TA-650']}], 'interventions': [{'name': 'TA-650', 'type': 'DRUG', 'otherNames': ['Infliximab'], 'description': '(1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.', 'armGroupLabels': ['TA-650']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kansai', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kanto', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kyushu', 'country': 'Japan', 'facility': 'Investigational site'}], 'overallOfficials': [{'name': 'Toshifumi Hibi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Internal Medicine, Keio University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}