Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 4:44 AM
Study NCT ID:
NCT01721161
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BIIB033 In Acute Optic Neuritis (AON)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hong Kong']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625770', 'term': 'opicinumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were monitored from administration of first dose of study treatment through to Week 32 visit. SAEs were monitored from signing of the Informed Consent Form (ICF) through to Week 32 visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)', 'otherNumAtRisk': 41, 'otherNumAffected': 25, 'seriousNumAtRisk': 41, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'BIIB033 100 mg/kg', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)', 'otherNumAtRisk': 41, 'otherNumAffected': 27, 'seriousNumAtRisk': 41, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Colour blindness acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Uhthoff's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cytomegalovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.83', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '17.34', 'spread': '2.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3337', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.48', 'ciLowerLimit': '-10.61', 'ciUpperLimit': '3.65', 'estimateComment': 'Difference is calculated as BIIB033 100 mg/kg - placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.77', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-15.66', 'spread': '2.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1868', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.89', 'ciLowerLimit': '-9.70', 'ciUpperLimit': '1.92', 'estimateComment': 'Difference is calculated as BIIB033 100 mg/kg - placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\\*100. Adjusted for the baseline RNFL thickness.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.22', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-16.98', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1488', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.76', 'ciLowerLimit': '-11.26', 'ciUpperLimit': '1.74', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\\*100. Adjusted for the baseline RNFL thickness.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.90', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-11.05', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4975', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-4.51', 'ciUpperLimit': '2.21', 'estimateComment': 'Difference is calculated as BIIB033 100 mg/kg - placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.17', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-11.93', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.76', 'ciLowerLimit': '-5.50', 'ciUpperLimit': '1.98', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'title': 'LCLA 1.25% chart', 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'LCLA 2.5% chart', 'categories': [{'measurements': [{'value': '11.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5371', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '3.6', 'estimateComment': 'Difference is calculated as BIIB033 100 mg/kg - placebo.', 'groupDescription': 'LCLA 1.25% chart', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '4.9', 'estimateComment': 'Difference is calculated as BIIB033 100 mg/kg - placebo.', 'groupDescription': 'LCLA 2.5% chart', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.', 'unitOfMeasure': 'letters on a chart', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Change in LCLA at Week 24: Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'title': 'LCLA 1.25% chart', 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'LCLA 2.5% chart', 'categories': [{'measurements': [{'value': '11.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '4.3', 'groupDescription': 'LCLA 1.25% chart', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'DIfference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '5.2', 'groupDescription': 'LCLA 2.5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.', 'unitOfMeasure': 'letters on a chart', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'PRIMARY', 'title': 'Change in FF-VEP Latency at Week 24: Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '22.24', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '14.69', 'spread': '2.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.55', 'ciLowerLimit': '-15.12', 'ciUpperLimit': '0.01', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'OG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'title': 'Participants with an event', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Participants with a moderate or severe event', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Participants with a severe event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants with a related event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Participants with a serious event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Participants with a related serious event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants discontinuing treatment due to event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants withdrawing from study due to event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '32 weeks', 'description': 'An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Summary of BIIB033 Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'classes': [{'title': 'Baseline predose; n=41', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.22'}]}]}, {'title': 'Baseline postdose; n=40', 'categories': [{'measurements': [{'value': '2030.00', 'groupId': 'OG000', 'lowerLimit': '1370.00', 'upperLimit': '3200.00'}]}]}, {'title': 'Week 4 predose; n=41', 'categories': [{'measurements': [{'value': '375.00', 'groupId': 'OG000', 'lowerLimit': '14.60', 'upperLimit': '2960.00'}]}]}, {'title': 'Week 4 postdose; n=37', 'categories': [{'measurements': [{'value': '2350.00', 'groupId': 'OG000', 'lowerLimit': '368.00', 'upperLimit': '3590.00'}]}]}, {'title': 'Week 8 predose; n=38', 'categories': [{'measurements': [{'value': '537.00', 'groupId': 'OG000', 'lowerLimit': '32.70', 'upperLimit': '1130.00'}]}]}, {'title': 'Week 8 postdose; n=36', 'categories': [{'measurements': [{'value': '2585.00', 'groupId': 'OG000', 'lowerLimit': '550.00', 'upperLimit': '4220.00'}]}]}, {'title': 'Week 12 predose; n=36', 'categories': [{'measurements': [{'value': '622.00', 'groupId': 'OG000', 'lowerLimit': '39.90', 'upperLimit': '3230.00'}]}]}, {'title': 'Week 12 postdose; n=34', 'categories': [{'measurements': [{'value': '2695.00', 'groupId': 'OG000', 'lowerLimit': '542.00', 'upperLimit': '4240.00'}]}]}, {'title': 'Week 16 predose; n=35', 'categories': [{'measurements': [{'value': '593.00', 'groupId': 'OG000', 'lowerLimit': '173.00', 'upperLimit': '1320.00'}]}]}, {'title': 'Week 16 postdose; n=34', 'categories': [{'measurements': [{'value': '2500.00', 'groupId': 'OG000', 'lowerLimit': '1560.00', 'upperLimit': '4590.00'}]}]}, {'title': 'Week 20 predose; n=37', 'categories': [{'measurements': [{'value': '673.00', 'groupId': 'OG000', 'lowerLimit': '107.00', 'upperLimit': '4760.00'}]}]}, {'title': 'Week 20 postdose; n=35', 'categories': [{'measurements': [{'value': '2530.00', 'groupId': 'OG000', 'lowerLimit': '366.00', 'upperLimit': '3990.00'}]}]}, {'title': 'Week 24; n=37', 'categories': [{'measurements': [{'value': '624.00', 'groupId': 'OG000', 'lowerLimit': '4.30', 'upperLimit': '1060.00'}]}]}, {'title': 'Week 32; n=33', 'categories': [{'measurements': [{'value': '82.70', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '339.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32 weeks', 'description': 'One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'FG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'BG001', 'title': 'BIIB033', 'description': 'BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '8.85', 'groupId': 'BG000'}, {'value': '31.8', 'spread': '7.17', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '8.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Days from first AON symptom to first dose', 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '23.6', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '24.1', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'First dose given, on average, 2 weeks after completion of high-dose (1 g daily for 3 to 5 days) IV methylprednisolone treatment.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Days from confirmed AON diagnosis to first dose', 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '18.7', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '19.0', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Affected eye', 'classes': [{'title': 'Right eye', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Left eye', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Criteria for AON diagnosis', 'classes': [{'title': 'Decreased visual acuity', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Decreased color vision', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Relative afferent pupillary defect', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Visual field defect', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Ocular pain', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Not specified', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'AON signs and symptoms at screening or baseline', 'classes': [{'title': 'Visual field defect', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Color desaturation', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': "Uhthoff's symptom", 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Swollen optic disc', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Relative afferent pupillary defect', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Symptoms were not uniformly tested in accordance with a predefined protocol.', 'unitOfMeasure': 'participants'}, {'title': 'FF-VEP conduction block in the affected eye at baseline', 'classes': [{'title': 'FF-VEP conduction block', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'No FF-VEP conduction block', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'FF-VEP=full-field visual evoked potentials', 'unitOfMeasure': 'participants'}, {'title': 'FF-VEP latency in the fellow eye at baseline', 'classes': [{'categories': [{'measurements': [{'value': '101.7', 'spread': '5.25', 'groupId': 'BG000'}, {'value': '102.7', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '102.2', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'RGCL/IPL thickness in the affected eye at baseline', 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'RGCL/IPL=retinal ganglion cell layer/inner plexiform retinal layer. n=38 in the placebo group and n=40 in the anti-LINGO-1 group, total n=78.', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brain Gd+ lesions before first dose', 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '0.4', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gd+=gadolinium-enhancing. n=38 in each group, total n=76.', 'unitOfMeasure': 'lesions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Volume of brain T2 lesions before first dose', 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '1.32', 'groupId': 'BG000'}, {'value': '1.09', 'spread': '1.90', 'groupId': 'BG001'}, {'value': '1.09', 'spread': '1.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'n=38 in each group, total n=76.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'dispFirstSubmitDate': '2015-08-21', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2012-10-25', 'dispFirstSubmitQcDate': '2015-08-21', 'resultsFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2012-11-01', 'dispFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-24', 'studyFirstPostDateStruct': {'date': '2012-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.'}, {'measure': 'Change in FF-VEP Latency at Week 24: Per-protocol Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\\*100. Adjusted for the baseline RNFL thickness.'}, {'measure': 'Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye\\*100. Adjusted for the baseline RNFL thickness.'}, {'measure': 'Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.'}, {'measure': 'Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.'}, {'measure': 'Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.'}, {'measure': 'Change in LCLA at Week 24: Per-protocol Population', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '32 weeks', 'description': 'An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.'}, {'measure': 'Summary of BIIB033 Concentration', 'timeFrame': 'Up to 32 weeks', 'description': 'One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Optic Neuritis'], 'conditions': ['Acute Optic Neuritis']}, 'referencesModule': {'references': [{'pmid': '30267385', 'type': 'DERIVED', 'citation': 'Klistorner A, Chai Y, Leocani L, Albrecht P, Aktas O, Butzkueven H, Ziemssen T, Ziemssen F, Frederiksen J, Xu L, Cadavid D; RENEW MF-VEP Investigators. Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential. CNS Drugs. 2018 Dec;32(12):1159-1171. doi: 10.1007/s40263-018-0575-8.'}, {'pmid': '30095536', 'type': 'DERIVED', 'citation': 'Petrillo J, Balcer L, Galetta S, Chai Y, Xu L, Cadavid D. Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab. J Neuroophthalmol. 2019 Jun;39(2):153-160. doi: 10.1097/WNO.0000000000000697.'}, {'pmid': '28229892', 'type': 'DERIVED', 'citation': 'Cadavid D, Balcer L, Galetta S, Aktas O, Ziemssen T, Vanopdenbosch L, Frederiksen J, Skeen M, Jaffe GJ, Butzkueven H, Ziemssen F, Massacesi L, Chai Y, Xu L, Freeman S; RENEW Study Investigators. Safety and efficacy of opicinumab in acute optic neuritis (RENEW): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 Mar;16(3):189-199. doi: 10.1016/S1474-4422(16)30377-5. Epub 2017 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON). The secondary objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033 in this study population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Ability to provide written consent and any authorization required by law.\n* Confirmed diagnosis of AON\n* All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.\n\nKey Exclusion Criteria:\n\n* Prior episode(s) of optic neuritis or loss of vision not due to AON.\n* Subjects with an established diagnosis of multiple sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain magnetic resonance imaging results consistent with the 2010 revisions to the McDonald's criteria.\n* Previous history of a clinically significant disease.\n* Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.\n* History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.\n* History or evidence of drug or alcohol abuse within 2 years prior to Screening.\n* Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.\n\nNOTE: Other protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01721161', 'briefTitle': 'BIIB033 In Acute Optic Neuritis (AON)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis', 'orgStudyIdInfo': {'id': 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