Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-26 @ 2:44 AM
Study NCT ID:
NCT02771860
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2016-03-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints
Sponsor:
Organization:
Raw JSON
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Ruth Wittoek', 'organization': 'University Gent'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored/assessed during the placebo controlled phase from the first dose administration up to Week 48.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Comparator: Experimental: Denosumab', 'description': '51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 41, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Comparator - Placebo', 'description': '49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 44, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 41, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 38, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrointestinal event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal complaints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nervous system disorders (incl. dizziness, vertigo, headache)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary and respiratory complaintes (non-infectious)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash and skin problmes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergy (systemic and urticaria)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Theet problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Major cardiovascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal complaints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Ghent University Scoring System (GUSS) of Target Joints at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Experimental: Denosumab', 'description': '51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}, {'id': 'OG001', 'title': 'Comparator - Placebo', 'description': '49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '162.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '153.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '1.0', 'ciUpperLimit': '16.9', 'groupDescription': 'Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair (better outcome), and negative changes with erosive progression (worse outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) population (i.e., all participants randomly assigned to groups and who attended a baseline visit)'}, {'type': 'SECONDARY', 'title': 'Number of New Erosive Joints by Verbruggen and Veys at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'units': 'joints', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Experimental: Denosumab', 'description': '51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}, {'id': 'OG001', 'title': 'Comparator - Placebo', 'description': '49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.50', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'These are the number of new erosive IP joints according to the Verbruggen and Veys anatomical scoring system amongst the pre-erosive joints (i.e., N, S, J joints) at 48 weeks.', 'unitOfMeasure': 'joints', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'joints', 'denomUnitsSelected': 'joints', 'populationDescription': 'intention-to-treat (ITT) population (i.e., all participants randomly assigned to groups and who attended a baseline visit)'}, {'type': 'SECONDARY', 'title': 'Total Ghent University Scoring System (GUSS) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator: Experimental: Denosumab', 'description': '51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}, {'id': 'OG001', 'title': 'Comparator - Placebo', 'description': '49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '163.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '149.2', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '4.6', 'ciUpperLimit': '24.0', 'groupDescription': 'Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.', 'statisticalMethod': 'GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 weeks', 'description': 'The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair, and negative changes with erosive progression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat (ITT) population (i.e., all participants randomly assigned to groups and who attended a baseline visit)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of (Serious) Adverse Events', 'timeFrame': '48 weeks', 'description': 'Number of patients who have experienced one or more (serious) adverse events throughout the study', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Comparator: Experimental: Denosumab', 'description': '51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}, {'id': 'FG001', 'title': 'Comparator - Placebo', 'description': '49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Comparator: Experimental: Denosumab', 'description': '51 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}, {'id': 'BG001', 'title': 'Comparator - Placebo', 'description': '49 patients were enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of radiographically affected joints', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '3.8', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Any radiographically defined S, J, E, R joint, according to the Verbruggen and Veys score of 16 joints per patient', 'unitOfMeasure': 'count', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ghent University scoring system (GUSS) of all joints', 'classes': [{'categories': [{'measurements': [{'value': '249', 'spread': '66', 'groupId': 'BG000'}, {'value': '248', 'spread': '67', 'groupId': 'BG001'}, {'value': '249', 'spread': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair (better outcome), and negative changes with erosive progression (worse outcome).\n\nAll joints refer to all proximal and distal IP joints (n = 16) (excluding 1st IP) in a patient.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ghent University scoring system (GUSS) of target joints', 'classes': [{'categories': [{'measurements': [{'value': '155.9', 'spread': '69.3', 'groupId': 'BG000'}, {'value': '158.7', 'spread': '46.8', 'groupId': 'BG001'}, {'value': '157.3', 'spread': '58.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair (better outcome), and negative changes with erosive progression (worse outcome).\n\nTarget joints are predefined at baseline according to the protocol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'on a numerical rating scale (0-10), with 0 corresponds to no pain and 10 to maximal pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Australian-Canadian Hand Osteoarthritis index, subscale pain', 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '21.7', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sores of the Australian-Canadian Hand Osteoarthritis Index (AUSCAN) subscale pain ranges from 0 to 50, with higher scores indicating more pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Australian-Canadian Hand Osteoarthritis index, subscale function', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '21.9', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '24.9', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '23.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores of the Australian-Canadian Hand Osteoarthritis Index (AUSCAN) subscale function range from 0 to 90, with higher scores indicating more disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Functional Index for Hand Osteoarthritis (FIHOA)', 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '10.3', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Scores of the Functional Index for Hand Osteoarthritis (FIHOA) range from 0 to 30, with higher scores indicating more disability', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-16', 'size': 1267442, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-20T09:13', 'hasProtocol': True}, {'date': '2020-03-29', 'size': 664275, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-20T09:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2016-03-18', 'resultsFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-31', 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of (Serious) Adverse Events', 'timeFrame': '48 weeks', 'description': 'Number of patients who have experienced one or more (serious) adverse events throughout the study'}], 'primaryOutcomes': [{'measure': 'Total Ghent University Scoring System (GUSS) of Target Joints at Week 24', 'timeFrame': '24 weeks', 'description': 'The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair (better outcome), and negative changes with erosive progression (worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Number of New Erosive Joints by Verbruggen and Veys at Week 48', 'timeFrame': '48 weeks', 'description': 'These are the number of new erosive IP joints according to the Verbruggen and Veys anatomical scoring system amongst the pre-erosive joints (i.e., N, S, J joints) at 48 weeks.'}, {'measure': 'Total Ghent University Scoring System (GUSS) at Week 48', 'timeFrame': '48 weeks', 'description': 'The Ghent University Scoring System, GUSS, is quantitative radiographic scoring system and found to be a reliable method to score radiographic change over time in erosive IP OA. It includes assessment of proportions of normal subchondral bone, subchondral plate and joint space over time. Range of score: min: 0 max:300. Change scores are measured where positive changes corresponds with remodeling or repair, and negative changes with erosive progression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['denosumab', 'RANKL-blockade'], 'conditions': ['Hand Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double blind placebo controlled one-site proof-of-concept study in subjects with erosive osteoarthritis (OA) of interphalangeal (IP) finger joints.\n\nA total of 100 subjects will be enrolled into the study: 48 weeks placebo controlled double-blind phase with denosumab 60mg every 12 weeks, followed by a 48-week open-label phase in which all subjects will receive denosumab.', 'detailedDescription': 'Investigational therapy: denosumab 60mg subcutaneous injection every 12 weeks. All subjects will receive Calcium/vit D supplementation.\n\nEfficacy objectives:\n\nThe primary objective is to assess the effect of denosumab on the reduction of radiographic erosive progression using the Ghent University Score System (GUSS).\n\nThe secondary objective is to assess the effect of denosumab on the reduction of radiographic erosive progression as defined by diminishing the appearance of new erosive IP finger joints.\n\nThe exploratory objective is mainly to assess the effect of denosumab on clinical variables, as well as ultrasonography and dual energy x-ray absorptiometry parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Subjects with hand OA having suffered from transient inflammatory attacks of the interphalangeal finger joints characteristic for what has been termed 'inflammatory' or 'erosive' hand OA.\n\n * Subjects with hand OA showing inflammatory signs, either clinically or ultrasonographically, of the interphalangeal finger joints.\n * Subjects with hand OA in which at least 1 interphalangeal finger joint has the typical appearance on the X-rays of a 'J' or 'E' phase joint as defined by the criteria mentioned above.\n * Subjects with hand OA where at least 1 interphalangeal finger joint in the 'J' or 'E' phase presents a palpable swelling.\n\nExclusion Criteria:\n\n* Patients with known hypersensitivities to mammalian-derived drug preparations.\n* Patients with clinically significant hypersensitivity to any of the components of Prolia.\n* Current and/or Prior treatment with any investigational agent within 90 days, or five half-lives of the product, whichever is longer.\n* Previous administration of denosumab from clinical trials or others (e.g. commercial use).\n* Vitamin D deficiency \\[25(OH) vitamin D level \\< 20 ng/mL (\\< 49.9 nmol/L)\\]. Possibility of replenishment and re-screening.\n* Subjects with current hypo- or hypercalcemia (normal serum calcium levels: 8.5-10.5 mg/dl or 2.12-2.62 mmol/L).\n* Patients currently under bisphosphonate (BP) treatment or any use of oral BPs within 12 months of study enrollment or intravenous BPs or strontium ranelate within 5 years of study enrollment\n* Prior use of any chondroprotective drug within 90 days e.g. chondroitin sulfate, glucosamine, avocado-soybean unsaponifiables, tetracyclins, corticosteroids.\n* Prior use of any immunomodulating drug with possible effects on proinflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, D-Penicillin, anti-malarials, cytotoxic drugs, tumor necrosis factor (TNF) blocking agents.\n* History of drug or alcohol abuse in the last year.\n* Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis, spondylarthropathy, psoriatic arthritis, gout, chondrocalcinosis or other auto-immune diseases, e.g. systemic lupus erythematosus).\n* History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years.\n* History of any Solid Organ or Bone Marrow Transplant.\n* Comorbidities: significant renal function impairment (glomerular filtration \\< 30 ml/min/1.73m2 or \\<50% of normal value), uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), uncontrolled hypo or hyperparathyroidism, active inflammatory bowel disease, malabsorption, liver failure or chronic hepatic disease (serum aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) levels 3 times above normal), recent stroke (within three months), chronic leg ulcer and any other condition (e.g,. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.\n* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures .\n* Patient who is pregnant or planning pregnancy; if the female subject is of child-bearing age, she must use a valid mean of contraception during the study and for 9 months after last dose of study medication. For males with a partner of childbearing potential: subject refuses to use 1 effective methods of contraception for the duration of the study and for 10 months after the last dose of study medication.\n* Female subjects who are breast-feeding.\n* History of osteonecrosis of the jaw, and/or recent (within 3 months) tooth extraction or other unhealed dental surgery; or planned invasive dental work during the study."}, 'identificationModule': {'nctId': 'NCT02771860', 'briefTitle': 'RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Denosumab 60mg sc Every 3 Months in Patients With Erosive Osteoarthritis of the Interphalangeal (IP) Finger Joints', 'orgStudyIdInfo': {'id': 'AGO/2015/008'}, 'secondaryIdInfos': [{'id': '2015-003223-53', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental: denosumab', 'description': '50 patients will be enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks denosumab 60mg sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks. Calcium and vit D supplementation will be installed at baseline.', 'interventionNames': ['Drug: denosumab', 'Dietary Supplement: Calcium/Vit D supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Comparator', 'description': '50 patients will be enrolled in this group for a total treatment duration of 24 months (96 weeks): 48 weeks placebo sc every 12 weeks followed by a 48-weeks open label phase denosumab 60mg sc every 12 weeks.\n\nCalcium and vit D supplementation will be installed at baseline', 'interventionNames': ['Drug: denosumab', 'Drug: Placebo', 'Dietary Supplement: Calcium/Vit D supplementation']}], 'interventions': [{'name': 'denosumab', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': '60mg sc', 'armGroupLabels': ['Comparator', 'Experimental: denosumab']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['placebo comparator'], 'description': 'identical syringe', 'armGroupLabels': ['Comparator']}, {'name': 'Calcium/Vit D supplementation', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Steovit forte'], 'description': 'Daily dosage Calcium 1000mg / Vit D 880 IU', 'armGroupLabels': ['Comparator', 'Experimental: denosumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Dirk Elewaut, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Ghent'}, {'name': 'August Verbruggen, Prof Dr. Em.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Ghent'}, {'name': 'Ruth Wittoek, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}