Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-27 @ 12:15 PM
Study NCT ID:
NCT02756650
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541220', 'term': 'canakinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+1 (862) 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This was an exploratory trial that was not powered for a statistical analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment', 'description': 'An AE is any sign or symptom that occurs during the study treatment plus the # days post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'ACZ885N', 'description': 'Canakinumab', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Nystagmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Genital ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Testicular swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Pulmonary artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Attacks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': "Resolution of acute exacerbation findings related to Behçet's Disease (BD). The attacks were assessed by pyhsician global assesment.\n\nFor patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30\n\nThis was an exploratory trial that was not powered for a statistical analysis.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: all 8 subjects who took at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Modified Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '2.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Scale range is between 0-10 with 10 being most disability. Mean score of 3 participants who were evaluated in Neurology clinic. Other 5 participants were not evaluated for EDSS.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Behçet's Disease set"}, {'type': 'PRIMARY', 'title': "Neuro-Behçet's Disability Score (NBDS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '1.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': "Neuro-Behçet's disability score (NBDS) has been proposed for parenchymal-NBD patients to quantify disabilities. This comprises scores for motor and cognitive status. NBDS is the arithmetic sum of both scores and ranges from 0 to 8, with 8 being death due to NBD. 3 neurologic participants were evaluated.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Behçet's disease set"}, {'type': 'PRIMARY', 'title': 'Modified Ranking Score (mRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '1.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mean Modified Rankin Scale (mRS): mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-5 with 5 being the worst outcome. Only 3 participants from neurology clinic were evaluated with this scale.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Behçet's disease set"}, {'type': 'PRIMARY', 'title': 'Ataxia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized set'}, {'type': 'PRIMARY', 'title': 'Physical Examination Scores Indicating Change in Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'title': 'Upper right extremity', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lower right extremity', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Upper left extremity', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Lower left extremity', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'All 4 extremties were evaluated for muscle strength (upper right, upper left, lower right and lower left) fro each patient. Score 0 is the worst outcome whereas 5 is the best outcome for muscle strength. 3 participants from neurology clinic were assessed.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Behçet's disease set"}, {'type': 'PRIMARY', 'title': 'C-reactive Protein (CRP) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '14.58', 'spread': '20.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mean CRP (C-reactive protein) value (8 participants)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '12.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mean erythrocyte sedimentation rate (ESR) value (8 participants)', 'unitOfMeasure': 'mm/H', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'SAA (Serum Amyloid A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '78.66', 'spread': '108.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mean Serum Amyloid A value (8 participants)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'The number of the participants with hemoptysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scores (VAS) for Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'title': 'VAS by participants', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'VAS by Physicians', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Headache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain\'\'. Physician and participant determined the VAS score separately.', 'unitOfMeasure': 'average of scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scores (VAS) for Stomachache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'title': 'VAS by participants', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'VAS by physicians', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Stomacheache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain\'\'. VAS is determined separately by physician and the participants.', 'unitOfMeasure': 'average of scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scores (VAS) for Extremity Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'title': 'VAS by participants', 'categories': [{'measurements': [{'value': '1.07', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'VAS by physicians', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Extremity assessments were measured by VAS where score 0 means "no pain," and score 10 means "the worst possible pain\'\'. The physicians and participants evaluated VAS separately.', 'unitOfMeasure': 'average of scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': "Visual Analogue Scores (VAS) for Patients' General Assessments", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1.72', 'spread': '1.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Participants assessed their own well-being with VAS (visual analogue scale). Score 0 means the best outcome, score 10 is the worst outcome.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': "Physician's Global Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '0.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': "Physician's General Assessments is VAS scale, ranging between 0-5, showing the disease status of participants. Score 0 is the worst outcome; 5 is the best outcome", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Steroid Dose Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '2.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Mean steroid treatment dose (8 participants)', 'unitOfMeasure': 'mg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': "BDCAF (Behçet's Disease Current Activity Form)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'BDCAF is an assessment that is made by physician for evaluating the disease activity in last four weeks. Score range is 0 to 12, 0 is the best outcome, 12 is the worst outcome.', 'unitOfMeasure': 'scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}, {'type': 'PRIMARY', 'title': 'Extremity (Localized) Pain Assessment (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '1.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'randomized set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '8 subjects enrolled 5 subjects were evaluated in Rheumatology clinic. 3 subjects were evaluated in Neurology clinic.', 'preAssignmentDetails': 'Ten patients were planned to be enrolled. Nine patients were screened. Eight patients were enrolled. Six patients completed the study. One patient was dropped out in the 7th visit because of an unknown drug abuse. One patient was dropped out in the 11th visit because of adverse event, worsening in pulmonary artery aneurysm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ACZ885N', 'description': 'Canakinumab'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.25', 'spread': '2.320', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-15', 'size': 675771, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-31T12:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2016-03-31', 'resultsFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-28', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Attacks', 'timeFrame': '30 days', 'description': "Resolution of acute exacerbation findings related to Behçet's Disease (BD). The attacks were assessed by pyhsician global assesment.\n\nFor patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30\n\nThis was an exploratory trial that was not powered for a statistical analysis."}, {'measure': 'Modified Expanded Disability Status Scale (EDSS)', 'timeFrame': '30 days', 'description': 'The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Scale range is between 0-10 with 10 being most disability. Mean score of 3 participants who were evaluated in Neurology clinic. Other 5 participants were not evaluated for EDSS.'}, {'measure': "Neuro-Behçet's Disability Score (NBDS)", 'timeFrame': '30 days', 'description': "Neuro-Behçet's disability score (NBDS) has been proposed for parenchymal-NBD patients to quantify disabilities. This comprises scores for motor and cognitive status. NBDS is the arithmetic sum of both scores and ranges from 0 to 8, with 8 being death due to NBD. 3 neurologic participants were evaluated."}, {'measure': 'Modified Ranking Score (mRS)', 'timeFrame': '30 days', 'description': 'Mean Modified Rankin Scale (mRS): mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-5 with 5 being the worst outcome. Only 3 participants from neurology clinic were evaluated with this scale.'}, {'measure': 'Ataxia', 'timeFrame': '30 days', 'description': 'Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.'}, {'measure': 'Physical Examination Scores Indicating Change in Muscle Strength', 'timeFrame': '30 days', 'description': 'All 4 extremties were evaluated for muscle strength (upper right, upper left, lower right and lower left) fro each patient. Score 0 is the worst outcome whereas 5 is the best outcome for muscle strength. 3 participants from neurology clinic were assessed.'}, {'measure': 'C-reactive Protein (CRP) Values', 'timeFrame': '30 days', 'description': 'Mean CRP (C-reactive protein) value (8 participants)'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': '30 days', 'description': 'Mean erythrocyte sedimentation rate (ESR) value (8 participants)'}, {'measure': 'SAA (Serum Amyloid A)', 'timeFrame': '30 days', 'description': 'Mean Serum Amyloid A value (8 participants)'}, {'measure': 'Hemoptysis', 'timeFrame': '30 days', 'description': 'The number of the participants with hemoptysis'}, {'measure': 'Visual Analogue Scores (VAS) for Headache', 'timeFrame': '30 days', 'description': 'Headache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain\'\'. Physician and participant determined the VAS score separately.'}, {'measure': 'Visual Analogue Scores (VAS) for Stomachache', 'timeFrame': '30 days', 'description': 'Stomacheache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain\'\'. VAS is determined separately by physician and the participants.'}, {'measure': 'Visual Analogue Scores (VAS) for Extremity Assessments', 'timeFrame': '30 days', 'description': 'Extremity assessments were measured by VAS where score 0 means "no pain," and score 10 means "the worst possible pain\'\'. The physicians and participants evaluated VAS separately.'}, {'measure': "Visual Analogue Scores (VAS) for Patients' General Assessments", 'timeFrame': '30 days', 'description': 'Participants assessed their own well-being with VAS (visual analogue scale). Score 0 means the best outcome, score 10 is the worst outcome.'}, {'measure': "Physician's Global Assessment", 'timeFrame': '30 days', 'description': "Physician's General Assessments is VAS scale, ranging between 0-5, showing the disease status of participants. Score 0 is the worst outcome; 5 is the best outcome"}, {'measure': 'Steroid Dose Regimen', 'timeFrame': '30 days', 'description': 'Mean steroid treatment dose (8 participants)'}, {'measure': "BDCAF (Behçet's Disease Current Activity Form)", 'timeFrame': '30 days', 'description': 'BDCAF is an assessment that is made by physician for evaluating the disease activity in last four weeks. Score range is 0 to 12, 0 is the best outcome, 12 is the worst outcome.'}, {'measure': 'Extremity (Localized) Pain Assessment (VAS)', 'timeFrame': '30 days', 'description': 'Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behcet Disease', 'Inflammation', 'Immune system', 'Arthritis'], 'conditions': ['Behcet Disease']}, 'descriptionModule': {'briefSummary': 'Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.', 'detailedDescription': "Primary endpoint: Resolution of acute exacerbation findings related to Behçet's Disease (BD) based on achievements in any of the following items without deterioration on day 30:\n\nFor patients with parenchymal neurologic disease: Resolution of acute exacerbation of parenchymal neurologic findings based on improvements in any of the following items without deterioration on Day 30:\n\n* Improvement of muscle strength, ataxia, or other relevant neurologic findings depending on the involved region on neurological examination (by Neuro-Behçet's Disease Score, Modified Expanded Disability Status Scale, and Modified Rankin Scores) cerebrospinal fluid\n* Improvement in systemic inflammatory findings (CRP, Erythrocyte Sedimentation Rate , SAA)\n* Any decrease in the size of the MRI lesion, or disappearance of contrast enhancement\n* Improvement in patients' and physicians global assessment using a 10-cm visual analogue scale (VAS)\n\nComplete response was defined as full clinical recovery to the pre-attack state, disappearance of MRI lesion(s), and normalisation of Cerebrospinal Fluid findings.\n\nPartial response was defined as partial improvement in clinical findings, but with findings still worse than the pre-attack state, and MRI lesions, which become smaller with no or less enhancement, and a decrease in cerebrospinal fluid cell count.\n\nNon-response was defined as no improvement in clinical findings, no change on MRI, no change in cerebrospinal fluid parameters, or worsening in those findings.\n\nFor patients with large vessel vascular disease: Resolution of acute vascular exacerbation findings related to Behçet's Disease based on achievements in any of the following items without deterioration at 1 month:\n\n* Improvement in relevant symptoms (localised pain, abdominal pain, calf thickness, haemoptysis) by using physician and patient's global assessment with VAS\n* Improvement in systemic inflammatory findings (CRP, ESR, SAA)\n* Any improvement in radiological findings depending on the involved vessels (MR, CT or Doppler findings)\n* Improvement in patients' and physicians global assessment using a 10-cm visual analogue scale (VAS)\n\nComplete response was defined as clinical and laboratory improvement based on ≥50% improvements in patient's and physician's global assessments by using VAS, and ≥50% reduction in CRP values; along with stable or ≥20% reduced aneurysm size in patients with arterial involvement, and stable or ≥20% reduced calf swelling in patients with lower extremity venous thrombosis.\n\nPartial response was defined as clinical and laboratory improvement based on observations of an improvement between 20-49% according to patient's and physician's global assessments by using VAS, 20-49% reduction in CRP values; along with stable or less than 20% reduced aneurysm size in patients with arterial involvement, and stable or less than 20% reduced calf swelling in patients with lower extremity thrombosis.\n\nNon-response will be defined as observing no or less than 20% clinical improvement by patient's and physician's global VAS or worsening of clinical findings, no change or increase in acute phase response, increase in aneurysm size for patients with arterial involvement or progression of venous thrombosis in patients with venous involvement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged over 18-60 Behced Disease fulfilling the International Study Group (ISG) criteria, who have a recent exacerbation of large-vessel vascular disease and/or parenchymal neurologic disease For Neurologic Involvement\n\n* Patients experiencing an acute exacerbation of parenchymal neurologic disease involving brainstem and/or diencephalic region.\n* Exacerbation is defined based on the presence of both of the following:\n* An acute/subacute neurological syndrome including any of hemiparesis, ataxia, dysarthria,headache within the first month of onset of neurologic manifestations (without any prior high dose steroid treatment)\n* Compatible cranial MRI lesion involving brainstem and/or diencephalic region\n\nFor Vascular Disease :\n\nPatients experiencing an acute exacerbation of vascular disease within the last month, involving\n\n* Large arteries (abdominal aorta, pulmonary arteries, extremity arteries)\n* Large veins (deep vein thrombosis of extremities, caval vein thrombosis, dural sinus thrombosis)\n* Compatible radiological findings (spiral CT, MR, or Doppler ultrasonography)\n\nExclusion Criteria:\n\nFor Neurologic Involvement :\n\n* Presence of severe neurological sequelae from any previous attacks rendering the patient dependent on others physically or mentally\n* Any other neurological cause underlying the picture including ischemic central nervous system lesion on MRI\n* Any previous treatment with biological agents other than interferon-alpha or any previous treatment with cyclophosphamide\n* No interferon in the last 6 months, no Intra Venous Metilprednizolon in the past month\n\nFor Vascular disease and general :\n\n* Presence of severe vascular sequelae from any previous attacks rendering the patient dependent on others\n* Any other vascular disease complication the evaluation of exacerbation\n* Any previous treatment with biological agents other than interferon alpha, or any previous treatment with cyclophosphamide\n* No interferon alpha in the last 6 months, no IVMP in the past month\n* History of Squamo Cell Carcinoma OR Basal Cell Carcinoma in previous 5 years. General\n* Presence or history of any other inflammatory rheumatic disease\n* Positive Purified Protein Derivative test (according to local guidance) where an active Tuberculosis infection cannot be excluded via Quantiferon (T-Spot or radiographic imaging if needed) Pregnancy or lactation\n* Presence of any active or chronic infection or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral antibiotics within 14 days prior to screening\n* History or a malignancy within the last 5 years, except for successfully excised squamous or basal cell carcinoma of the skin\n* Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding\n* With known sensitivity to canakinumab\n* Use of any other investigational agent in the last 30 days'}, 'identificationModule': {'nctId': 'NCT02756650', 'acronym': 'Behcet', 'briefTitle': "1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "An Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular Involvement", 'orgStudyIdInfo': {'id': 'CACZ885NTR01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canakinumab', 'description': 'Canakinumab was administered monthly', 'interventionNames': ['Drug: Canakinumab']}], 'interventions': [{'name': 'Canakinumab', 'type': 'DRUG', 'otherNames': ['ACZ885'], 'description': '150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)', 'armGroupLabels': ['Canakinumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ahmet Gül, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'IU Faculty of Medicine'}, {'name': 'Murat Kurtuncu, Ass.Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IU Faculty of Medicine'}, {'name': 'Gulsen Akman Demir, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bilim University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The publication has been planned for Q4 2020.', 'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com', 'accessCriteria': 'Access from peer reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}