Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01199302
Status:
TERMINATED
Last Update Posted:
2021-12-28
First Post:
2010-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571216', 'term': 'brodalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)', 'eventGroups': [{'id': 'EG000', 'title': 'Brodalumab 350 mg Q4W', 'description': 'Participants received brodalumab 350 mg IV Q4W for up to 132 weeks.', 'otherNumAtRisk': 67, 'otherNumAffected': 36, 'seriousNumAtRisk': 67, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Peritoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cutaneous vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'title': 'All treatment-emergent adverse events (TEAEs)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to discontinuation from study', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related treatment-emergent adverse events', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related TEAEs leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Treatment related TEAEs leading to discontinuation from study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug.\n\nThe investigator assessed whether each AE was possibly related to the study drug.\n\nA serious adverse event is defined as an AE that met at least 1 of the following serious criteria:\n\n* fatal,\n* life threatening,\n* required in-patient hospitalization or prolongation of existing hospitalization,\n* resulted in persistent or significant disability/incapacity,\n* congenital anomaly/birth defect, and/or\n* other significant medical hazard.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of brodalumab in the extension study'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved a CDAI Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '54.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}, {'value': '47.4', 'groupId': 'OG002'}, {'value': '55.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '53.3', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '83.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '27.3', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '62.5', 'groupId': 'OG002'}, {'value': '80.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'CDAI response is defined as a reduction from baseline in CDAI score of ≥ 100 points.\n\nThe CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data at each time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '27.8', 'groupId': 'OG002'}, {'value': '27.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}, {'value': '26.3', 'groupId': 'OG002'}, {'value': '22.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '13.3', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '18.2', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '60.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'CDAI Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '291.71', 'spread': '159.01', 'groupId': 'OG000'}, {'value': '285.41', 'spread': '86.69', 'groupId': 'OG001'}, {'value': '235.12', 'spread': '100.66', 'groupId': 'OG002'}, {'value': '197.71', 'spread': '81.22', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '274.21', 'spread': '154.79', 'groupId': 'OG000'}, {'value': '244.11', 'spread': '62.60', 'groupId': 'OG001'}, {'value': '256.22', 'spread': '125.24', 'groupId': 'OG002'}, {'value': '192.04', 'spread': '54.62', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '257.09', 'spread': '154.96', 'groupId': 'OG000'}, {'value': '274.48', 'spread': '93.41', 'groupId': 'OG001'}, {'value': '241.13', 'spread': '134.06', 'groupId': 'OG002'}, {'value': '219.91', 'spread': '121.19', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '250.95', 'spread': '167.25', 'groupId': 'OG000'}, {'value': '248.03', 'spread': '70.86', 'groupId': 'OG001'}, {'value': '267.51', 'spread': '173.20', 'groupId': 'OG002'}, {'value': '159.39', 'spread': '66.53', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '196.56', 'spread': '157.07', 'groupId': 'OG000'}, {'value': '274.81', 'spread': '90.70', 'groupId': 'OG001'}, {'value': '276.37', 'spread': '138.48', 'groupId': 'OG002'}, {'value': '127.57', 'spread': '46.38', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '120.47', 'spread': '93.27', 'groupId': 'OG000'}, {'value': '317.49', 'spread': '27.14', 'groupId': 'OG001'}, {'value': '224.79', 'spread': '131.61', 'groupId': 'OG002'}, {'value': '159.91', 'spread': '61.03', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103.61', 'spread': '48.60', 'groupId': 'OG000'}, {'value': '220.67', 'spread': '178.45', 'groupId': 'OG002'}, {'value': '186.11', 'spread': '10.05', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '101.60', 'spread': '62.32', 'groupId': 'OG000'}, {'value': '212.42', 'groupId': 'OG001'}, {'value': '145.33', 'groupId': 'OG002'}, {'value': '223.11', 'spread': '13.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CDAI Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25.8', 'spread': '128.0', 'groupId': 'OG000'}, {'value': '-35.0', 'spread': '90.8', 'groupId': 'OG001'}, {'value': '-97.0', 'spread': '106.9', 'groupId': 'OG002'}, {'value': '-100.7', 'spread': '83.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-49.7', 'spread': '112.5', 'groupId': 'OG000'}, {'value': '-79.2', 'spread': '67.6', 'groupId': 'OG001'}, {'value': '-78.2', 'spread': '107.3', 'groupId': 'OG002'}, {'value': '-101.1', 'spread': '62.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-55.4', 'spread': '101.4', 'groupId': 'OG000'}, {'value': '-51.5', 'spread': '106.7', 'groupId': 'OG001'}, {'value': '-84.3', 'spread': '128.3', 'groupId': 'OG002'}, {'value': '-67.8', 'spread': '127.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-48.7', 'spread': '143.2', 'groupId': 'OG000'}, {'value': '-84.6', 'spread': '79.8', 'groupId': 'OG001'}, {'value': '-55.4', 'spread': '157.2', 'groupId': 'OG002'}, {'value': '-150.4', 'spread': '35.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-116.1', 'spread': '103.5', 'groupId': 'OG000'}, {'value': '-45.3', 'spread': '81.5', 'groupId': 'OG001'}, {'value': '-56.1', 'spread': '146.5', 'groupId': 'OG002'}, {'value': '-182.6', 'spread': '32.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-174.5', 'spread': '76.0', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '69.1', 'groupId': 'OG001'}, {'value': '-80.8', 'spread': '120.4', 'groupId': 'OG002'}, {'value': '-160.2', 'spread': '50.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-162.1', 'spread': '51.3', 'groupId': 'OG000'}, {'value': '-55.9', 'spread': '155.5', 'groupId': 'OG002'}, {'value': '-128.8', 'spread': '33.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-164.1', 'spread': '53.8', 'groupId': 'OG000'}, {'value': '-61.3', 'groupId': 'OG001'}, {'value': '-109.7', 'groupId': 'OG002'}, {'value': '-91.8', 'spread': '57.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Developed Anti-brodalumab Binding Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).', 'description': 'Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who received at least one dose of brodalumab in the extension study and with available antibody results'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-reactive Protein (CRP) Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'OG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'OG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '53.8', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '22.9', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '19.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '-8.1', 'spread': '25.9', 'groupId': 'OG002'}, {'value': '9.9', 'spread': '52.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '-5.1', 'spread': '30.0', 'groupId': 'OG002'}, {'value': '17.5', 'spread': '25.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '49.2', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '19.9', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '49.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '34.1', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '34.9', 'groupId': 'OG002'}, {'value': '-11.5', 'spread': '17.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '11.5', 'groupId': 'OG002'}, {'value': '-15.0', 'spread': '23.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-3.2', 'groupId': 'OG001'}, {'value': '-1.1', 'groupId': 'OG002'}, {'value': '-10.9', 'spread': '21.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the full analysis set with available data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'FG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'FG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'FG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study enrolled participants who had completed the week 12 visit of the parent study 20090072 (NCT01150890).\n\nThe study was conducted at 28 centers in Australia, Belgium, Canada, Spain, France, Netherlands, Poland, and the United States (US).', 'preAssignmentDetails': 'In this long-term open-label extension study participants were to receive brodalumab 350 mg every 4 weeks. Results are reported by treatment group assigned in the parent study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo / Brodalumab 350 mg', 'description': 'Participants who received placebo in the parent study received brodalumab 350 mg intravenously (IV) every 4 weeks (Q4W) for up to 132 weeks.'}, {'id': 'BG001', 'title': 'Brodalumab 210 mg / 350 mg', 'description': 'Participants who received 210 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'BG002', 'title': 'Brodalumab 350 mg / 350 mg', 'description': 'Participants who received 350 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'BG003', 'title': 'Brodaluamb 700 mg / 350 mg', 'description': 'Participants who received 700 mg brodalumab Q4W in the parent study received brodalumab 350 mg IV Q4W for up to 132 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '35.2', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '35.4', 'spread': '13.4', 'groupId': 'BG002'}, {'value': '37.6', 'spread': '13.2', 'groupId': 'BG003'}, {'value': '35.9', 'spread': '12.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Crohn's Disease Activity Index (CDAI) at Baseline of Parent Study", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '317.24', 'spread': '65.21', 'groupId': 'BG000'}, {'value': '321.13', 'spread': '54.01', 'groupId': 'BG001'}, {'value': '336.90', 'spread': '58.92', 'groupId': 'BG002'}, {'value': '298.37', 'spread': '43.75', 'groupId': 'BG003'}, {'value': '320.94', 'spread': '57.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': "Crohn's Disease Activity Index (CDAI) at Baseline of Extension Study", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '257.70', 'spread': '126.60', 'groupId': 'BG000'}, {'value': '251.72', 'spread': '85.23', 'groupId': 'BG001'}, {'value': '233.50', 'spread': '110.74', 'groupId': 'BG002'}, {'value': '226.76', 'spread': '65.49', 'groupId': 'BG003'}, {'value': '243.67', 'spread': '102.89', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}], 'populationDescription': 'The full analysis set included all participants who were enrolled and treated with at least one dose of brodalumab in the extension study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': "The study was terminated early based on an imbalance in worsening Crohn's disease in active treatment groups.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2015-12-14', 'completionDateStruct': {'date': '2011-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2010-09-09', 'dispFirstSubmitQcDate': '2015-12-14', 'resultsFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2010-09-09', 'dispFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-30', 'studyFirstPostDateStruct': {'date': '2010-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject including worsening of a pre-existing medical condition, and not necessarily having a causal relationship with study treatment. A treatment-emergent AE is an event that occurred after the initiation of study drug or was already present prior to the initiation of study drug but worsened in either intensity or frequency after the initiation of study drug.\n\nThe investigator assessed whether each AE was possibly related to the study drug.\n\nA serious adverse event is defined as an AE that met at least 1 of the following serious criteria:\n\n* fatal,\n* life threatening,\n* required in-patient hospitalization or prolongation of existing hospitalization,\n* resulted in persistent or significant disability/incapacity,\n* congenital anomaly/birth defect, and/or\n* other significant medical hazard.'}, {'measure': 'Percentage of Participants Who Achieved a CDAI Response', 'timeFrame': 'Baseline of the parent study and weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'CDAI response is defined as a reduction from baseline in CDAI score of ≥ 100 points.\n\nThe CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.'}, {'measure': 'Percentage of Participants Who Achieved Clinical Remission', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'Clinical remission is defined by a CDAI score of ≤ 150 points. The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.'}], 'secondaryOutcomes': [{'measure': 'CDAI Score Over Time', 'timeFrame': 'Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.'}, {'measure': 'Change From Baseline in CDAI Score Over Time', 'timeFrame': 'Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20', 'description': 'The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from 0 to 600, with higher scores indicating greater disease activity.'}, {'measure': 'Number of Participants Who Developed Anti-brodalumab Binding Antibodies', 'timeFrame': 'Blood samples were collected at study entry, week 4, 24 and at last visit (maximum time on study was 32 weeks).', 'description': 'Binding antibodies to brodalumab were detected using an anti-brodalumab immunoassay.'}, {'measure': 'Change From Baseline in C-reactive Protein (CRP) Levels Over Time', 'timeFrame': 'Baseline of the parent study and Weeks 2, 4, 6, 8, 10, 12, 16, and 20'}]}, 'conditionsModule': {'keywords': ['Amgen', "Crohn's", 'Inflammatory Bowel Disease', 'IBD', 'Irritable Bowel Syndrome', 'IBS', 'Inflammation', 'bowel', 'colon', 'gastrointestinal'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.", 'detailedDescription': "This study is an open-label extension of study 20090072 (NCT01150890) in adults with Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject was randomized into study 20090072 (NCT01150890) and completed the week 12 evaluation.\n* Subject completed the week 12 evaluation in study 20090072 no more than 1 year prior to the planned first visit of AMG 827 in 20100008.\n* Subject or subject's legally acceptable representative has provided informed consent.\n* Subject meets regional recommendations for immunizations, eg, United States Centers for Disease Control and Prevention recommendations for subjects enrolled in the United States.\n* For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: If testing is clinically indicated in the opinion of the investigator (eg, because of known recent exposure), then subject has negative test for hepatitis B, hepatitis C, and/or human immunodeficiency virus (HIV).\n* For female subjects with ≤ 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has a negative urine pregnancy test at baseline prior to the first dose of AMG 827 in the open-label extension (except those at least 2 years post menopausal or surgically sterile).\n* For female subjects with \\> 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has a negative serum pregnancy test within 28 days before initiating AMG 827 and a negative urine pregnancy test at baseline prior to the first dose of AMG 827 in the open-label extension (except those at least 2 years post menopausal or surgically sterile).\n* For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008, if clinically indicated in the opinion of the investigator (eg, because of known recent exposure) please assess the following:\n* If the subject entered 20090072 with a negative purified protein derivative (PPD) test: Subject must have a negative PPD test within 30 days prior to the planned first dose of AMG 827. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48-72 hours after test is placed.\n* If the subject entered 20090072 with a positive PPD: Subject must have a negative Quantiferon test within 30 days prior to the planned first dose of AMG 827.\n\nExclusion Criteria:\n\n* Subject had any serious adverse event reported during study 20090072 and considered to be related to investigational product.\n* Subject experienced an adverse event or laboratory abnormality in study 20090072 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject, prevent the subject from completing the study, or interfere with the interpretation of the study results.\n* Subject has known sensitivity to any of the products to be administered during dosing.\n\nOther medical conditions\n\n* Subject is currently experiencing an infection of Common Terminology Criteria for Adverse Events grade 2 (if requiring oral medication) or higher. Subject is ineligible until the infection resolves.\n* Subject has a serious infection, defined as requiring hospitalization or intravenous antibiotics, within 8 weeks before the first dose of AMG 827 in 20100008.\n* For subjects with ≥ 3 months between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has recurrent or chronic infections, defined as ≥ 3 infections requiring anti-microbials over the past 12 months prior to screening.\n* Subject has a significant concurrent medical condition, including\n* Type 1 diabetes\n* Uncontrolled type 2 diabetes\n* Moderate to severe heart failure (New York Heart Association class III or IV)\n* Myocardial infarction within the last year\n* Current or history of unstable angina pectoris within the last year\n* Uncontrolled hypertension as defined by resting blood pressure ≥ 150/90 mmHg prior to first investigational product dose (confirmed by a repeat assessment)\n* Severe chronic pulmonary disease (eg, requiring oxygen therapy)\n* Major chronic inflammatory disease or connective tissue disease other than Crohn's disease (eg, systemic lupus erythematosus, rheumatoid arthritis, psoriasis)\n* Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma\n* History of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin).\n* Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject\n* Laboratory abnormalities\n* For subjects with \\> 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008, subject has laboratory abnormalities at screening, including\n* Elevated aspartate aminotransferase or alanine aminotransferase (\\> 2x upper limit of normal)\n* Serum direct bilirubin ≥ 1.5x upper limit of normal\n* Hemoglobin \\< 10 g/dL\n* Hemoglobin A1c \\> 8.0 (for subjects with type 2 diabetes)\n* Platelet count \\< 125,000 /mm\\^3\n* White blood cell count \\< 3,000 cells/mm\\^3\n* Absolute neutrophil count \\< 2,000/mm\\^3\n* Creatinine clearance \\< 50 mL/min (Cockroft-Gault formula, central lab will calculate value and provide to sites)\n* Any other laboratory abnormality, which, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject, prevent the subject from completing the study, or interfere with the interpretation of the study results\n* Washouts and non-permitted drugs\n* Subject has used Tysabri (natalizumab) subsequent to study 20090072.\n* Subject received an anti-tumor necrosis factor agent within 8 weeks prior to the first dose of AMG 827 in 20100008.\n* Subject received other commercially available biologic agent (eg, ustekinumab) within 12 weeks prior to the first dose of AMG 827 in 20100008.\n* Subject received an investigational agent (other than AMG 827), investigational procedure, or participated in an investigational device study subsequent to study 20090072.\n* Subject received live vaccines within 12 weeks prior to the first dose of AMG 827 in 20100008.\n* Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus within 4 weeks prior to the first dose of AMG 827 in 20100008.\n* General or other\n* Female subject is not willing to use highly effective contraception during treatment with AMG 827 (except if at least 2 years postmenopausal or surgically sterile).\n* Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study.\n* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.\n* Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge."}, 'identificationModule': {'nctId': 'NCT01199302', 'briefTitle': "Long-term Safety Study of Brodalumab in Adults With Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': "A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease", 'orgStudyIdInfo': {'id': '20100008'}, 'secondaryIdInfos': [{'id': '2010-020881-53', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brodalumab 350 mg', 'description': 'Participants received brodalumab 350 mg intravenously (IV) on day 1, week 4 and every 4 weeks thereafter for up to 132 weeks.', 'interventionNames': ['Biological: Brodalumab']}], 'interventions': [{'name': 'Brodalumab', 'type': 'BIOLOGICAL', 'otherNames': ['AMG 827'], 'description': 'Administered intravenously once every 4 weeks', 'armGroupLabels': ['Brodalumab 350 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 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