Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 11:01 AM
Study NCT ID:
NCT04814368
Status:
TERMINATED
Last Update Posted:
2025-10-24
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Germany', 'Lithuania', 'Russia', 'Switzerland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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 (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The small sample size overall and the difference in group sizes do not allow a valid interpretation of the data regarding efficacy, pharmacokinetics and immunogenicity.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 52 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 8, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cartilage Volume in the Index Region Measured by MRI at Day 197 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}], 'classes': [{'categories': [{'measurements': [{'value': '108.33', 'spread': '226.451', 'groupId': 'OG000'}, {'value': '-26.13', 'spread': '65.204', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 197', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.', 'unitOfMeasure': 'µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'PRIMARY', 'title': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale (ACZ885 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}, {'id': 'OG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'spread': '20.09', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '13.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 85', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "ACZ885 600 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-LNA043 Antibodies (Placebo to ACZ885+LNA043 Versus ACZ885 + LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From pre-dose up to Day 365', 'description': 'To evaluate the immunogenicity of LNA043 via validated ligand-binding assay of potential anti-LNA043 antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacokinetic (PK) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "ACZ885 600mg + LNA043 40mg" who had an available value for the outcome measure. The PK analysis set included all participants who received any study drug, and had at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, and for whom there were no protocol deviations with impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of ANGPTL3 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '7.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose Day 1, Day 15, Day 43 and 60 minutes after first injection of LNA043 on Day 15', 'description': 'ANGPTL3 is a protein that is primarily involved in the lipid metabolism but has recently been shown to have chondrogenic and chondroprotective effects.\n\nCmax is defined as the maximum (peak) observed concentration following a dose. ANGPTL3 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). ANGPTL3 was determined by a validated ligand binding assay; the anticipated LLOQ is 39.7 pmol/L in serum.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacokinetic (PK) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "ACZ885 600mg + LNA043 40mg" who had an available value for the outcome measure. The PK analysis set included all participants who received any study drug, and had at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, and for whom there were no protocol deviations with impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Synovial Fluid Concentrations of ANGPTL3 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG001'}]}]}, {'title': 'Day 71', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = not measurable, below the lower limit of quantification of 2.74 ng/mL', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 1, 15, 43, and 71', 'description': 'ANGPTL3 is a protein that is primarily involved in the lipid metabolism but has recently been shown to have chondrogenic and chondroprotective effects.\n\nANGPTL3 was measured in synovial fluid.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacokinetic (PK) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "ACZ885 600mg + LNA043 40mg" who had an available value for the outcome measure. The PK analysis set included all participants who received any study drug, and had at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, and for whom there were no protocol deviations with impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15', 'description': 'Cmax is defined as the maximum (peak) observed concentration following a dose. LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacokinetic (PK) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "ACZ885 600mg + LNA043 40mg" who had an available value for the outcome measure. The PK analysis set included all participants who received any study drug, and had at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, and for whom there were no protocol deviations with impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Serum Concentration (Tmax) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15', 'description': 'Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacokinetic (PK) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "ACZ885 600mg + LNA043 40mg" who had an available value for the outcome measure. The PK analysis set included all participants who received any study drug, and had at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, and for whom there were no protocol deviations with impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}], 'classes': [{'categories': [{'measurements': [{'value': '800', 'groupId': 'OG000'}, {'value': '1880', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15', 'description': 'AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LNA043. LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacokinetic (PK) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "ACZ885 600mg + LNA043 40mg" who had an available value for the outcome measure. The PK analysis set included all participants who received any study drug, and had at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, and for whom there were no protocol deviations with impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Change in Cartilage Volume of the Index Region Measured by MRI at Day 197 and Day 365 (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG002', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 197', 'categories': [{'measurements': [{'value': '108.33', 'spread': '226.451', 'groupId': 'OG000'}, {'value': '307.90', 'spread': '580.213', 'groupId': 'OG001'}, {'value': '-82.33', 'spread': '390.645', 'groupId': 'OG002'}]}]}, {'title': 'Day 365', 'categories': [{'measurements': [{'value': '152.78', 'spread': '135.128', 'groupId': 'OG000'}, {'value': '20.54', 'spread': '557.708', 'groupId': 'OG001'}, {'value': '-129.93', 'spread': '544.793', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 197 and Day 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.', 'unitOfMeasure': 'µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg", "ACZ885 600 mg + LNA043 40 mg" and "ACZ885 600 mg" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Cartilage Volume of the Index Region Measured by MRI at Day 365 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}], 'classes': [{'categories': [{'measurements': [{'value': '152.78', 'spread': '135.128', 'groupId': 'OG000'}, {'value': '20.54', 'spread': '557.708', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.', 'unitOfMeasure': 'µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Cartilage Thickness of the Index Region Measured by MRI at Day 197 and Day 365 (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG002', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.212', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '0.121', 'groupId': 'OG002'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.168', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.152', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 197 and 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in thickness of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg", "ACZ885 600 mg + LNA043 40 mg" and "ACZ885 600 mg" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Cartilage Thickness of the Index Region Measured by MRI at Day 197 and Day 365 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}], 'classes': [{'title': 'Day 197', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.112', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.072', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 197 and 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in thickness of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Synovitis Level Measured From Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI) (ACZ885 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0009', 'spread': '0.01185', 'groupId': 'OG000'}, {'value': '-0.0051', 'spread': '0.00702', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 85', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee with dynamic contrast enhancement (DCE) to visualize and quantify changes in k-trans as a marker of the activity of synovial inflammation. During the DCE-MRI acquisition, while the contrast agent is preferentially taken up at sites with an increased perfusion due to the formation of new vessels with high porosity (such as the inflamed synovial membrane), a temporal variation of the MRI signal intensity occurs. When the contrast distributes through the intravascular and extravascular spaces, the MR signal intensity in the image volume elements (voxels) of the target tissue changes over time, generating so-called signal intensity (SI) curves. These curves can then be analyzed to derive parameters related to tissue perfusion. The parameter of primary interest was the volume transfer rate of the gadolinium-based contrast agent (GBCA) from the blood plasma in synovium, commonly referred to as Ktrans.', 'unitOfMeasure': 'min^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "ACZ885 600 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Numeric Rating Scale (NRS) Over Time (ACZ885 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85', 'description': 'The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. The scale ranges from 0 (no pain) to 10 (worst possible pain). The NRS Pain instrument had a recall period of 24 hours and the participants were asked to rate the pain intensity at its worst.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "ACZ885 600 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. In alignment with the study protocol, data collected beyond Day 85 for NRS pain is not part of this secondary outcome measure comparing the groups ACZ885 versus Placebo to ACZ885.'}, {'type': 'SECONDARY', 'title': 'Change in Numeric Rating Scale (NRS) Over Time (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG002', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '2.27', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '1.95', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.15', 'groupId': 'OG002'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.35', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '2.19', 'groupId': 'OG002'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '2.06', 'groupId': 'OG002'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '2.64', 'groupId': 'OG002'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '3.83', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85, 197 and 365', 'description': 'The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. The scale ranges from 0 (no pain) to 10 (worst possible pain). The NRS Pain instrument had a recall period of 24 hours and the participants were asked to rate the pain intensity at its worst.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg", "ACZ885 600 mg + LNA043 40 mg" and "ACZ885 600 mg" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Over Time (ACZ885 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '20.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '17.60', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '20.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '12.31', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '21.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '18.96', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '19.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '15.75', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '20.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '20.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "ACZ885 600 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. In alignment with the study protocol, data collected beyond Day 85 for KOOS pain subscale is not part of this secondary outcome measure comparing the groups ACZ885 versus Placebo to ACZ885.'}, {'type': 'SECONDARY', 'title': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Over Time (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG002', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '27.50', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '18.91', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '20.40', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.1', 'spread': '19.64', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '9.76', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '20.52', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '15.71', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '16.74', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '21.28', 'groupId': 'OG002'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '7.86', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '5.78', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '19.38', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.2', 'spread': '5.89', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '20.03', 'groupId': 'OG002'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '14.70', 'groupId': 'OG001'}, {'value': '22.2', 'spread': '20.09', 'groupId': 'OG002'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '9.82', 'groupId': 'OG000'}, {'value': '38.0', 'spread': '12.83', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '21.87', 'groupId': 'OG002'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.9', 'spread': '17.68', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '10.52', 'groupId': 'OG001'}, {'value': '31.5', 'spread': '26.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85, 197 and 365', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg", "ACZ885 600 mg + LNA043 40 mg" and "ACZ885 600 mg" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Subscale Over Time (ACZ885 Versus Placebo to ACZ885)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '23.87', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '18.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '24.74', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '20.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '17.04', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '19.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '28.06', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '21.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '22.30', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '19.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.7', 'spread': '23.05', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '19.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS Function in Daily Living (ADL) subscale consisting of 17 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "ACZ885 600 mg" and "Placebo to ACZ885" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. In alignment with the study protocol, data collected beyond Day 85 for KOOS function in daily living subscale is not part of this secondary outcome measure comparing the groups ACZ885 versus Placebo to ACZ885.'}, {'type': 'SECONDARY', 'title': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Subscale Over Time (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG001', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'OG002', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '34.32', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '8.82', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '18.35', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.6', 'spread': '20.80', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '4.49', 'groupId': 'OG001'}, {'value': '25.7', 'spread': '20.72', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.9', 'spread': '28.08', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '11.76', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '19.79', 'groupId': 'OG002'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.4', 'spread': '19.76', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '8.95', 'groupId': 'OG001'}, {'value': '31.8', 'spread': '21.99', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.4', 'spread': '23.92', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '10.29', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '19.40', 'groupId': 'OG002'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.9', 'spread': '19.76', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '15.09', 'groupId': 'OG001'}, {'value': '23.7', 'spread': '19.26', 'groupId': 'OG002'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.7', 'spread': '19.76', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '27.4', 'spread': '23.92', 'groupId': 'OG002'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.9', 'spread': '26.00', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '13.34', 'groupId': 'OG001'}, {'value': '33.6', 'spread': '23.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85, 197 and 365', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS Function in Daily Living (ADL) subscale consisting of 17 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the pharmacodynamic (PD) analysis set from the arms "Placebo to ACZ885+LNA043 40 mg", "ACZ885 600 mg + LNA043 40 mg" and "ACZ885 600 mg" who had an available value for the outcome measure. The PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'FG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}, {'id': 'FG002', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'FG003', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in 11 investigative sites in 6 countries.', 'preAssignmentDetails': 'The study consisted of 4 screening visits (Screening 1-4), of which Screening 2 and 4 could be performed remotely.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo to ACZ885+LNA043 40 mg', 'description': 'Placebo to ACZ885 single dose intra-articular (i.a) followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'BG001', 'title': 'Placebo to ACZ885', 'description': 'Placebo to ACZ885 single dose intra-articular.'}, {'id': 'BG002', 'title': 'ACZ885 600 mg + LNA043 40 mg', 'description': 'ACZ885 600 mg single dose i.a. followed by LNA043 40 mg administrated i.a every four weeks, three times.'}, {'id': 'BG003', 'title': 'ACZ885 600 mg', 'description': 'ACZ885 600 mg single dose intra-articular.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '10.97', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '5.90', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '7.02', 'groupId': 'BG002'}, {'value': '61.8', 'spread': '8.55', 'groupId': 'BG003'}, {'value': '61.8', 'spread': '7.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-08', 'size': 15908198, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-10T06:51', 'hasProtocol': True}, {'date': '2024-09-12', 'size': 625038, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-10T06:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking only applies to the canakinumab treatment. LNA043 treatment is open label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2021-03-22', 'resultsFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-07-11', 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cartilage Volume in the Index Region Measured by MRI at Day 197 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 197', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale (ACZ885 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 85', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Anti-LNA043 Antibodies (Placebo to ACZ885+LNA043 Versus ACZ885 + LNA043)', 'timeFrame': 'From pre-dose up to Day 365', 'description': 'To evaluate the immunogenicity of LNA043 via validated ligand-binding assay of potential anti-LNA043 antibodies.'}, {'measure': 'Maximum Serum Concentration (Cmax) of ANGPTL3 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'timeFrame': 'Pre-dose Day 1, Day 15, Day 43 and 60 minutes after first injection of LNA043 on Day 15', 'description': 'ANGPTL3 is a protein that is primarily involved in the lipid metabolism but has recently been shown to have chondrogenic and chondroprotective effects.\n\nCmax is defined as the maximum (peak) observed concentration following a dose. ANGPTL3 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). ANGPTL3 was determined by a validated ligand binding assay; the anticipated LLOQ is 39.7 pmol/L in serum.'}, {'measure': 'Synovial Fluid Concentrations of ANGPTL3 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'timeFrame': 'Pre-dose on Days 1, 15, 43, and 71', 'description': 'ANGPTL3 is a protein that is primarily involved in the lipid metabolism but has recently been shown to have chondrogenic and chondroprotective effects.\n\nANGPTL3 was measured in synovial fluid.'}, {'measure': 'Maximum Serum Concentration (Cmax) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'timeFrame': 'Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15', 'description': 'Cmax is defined as the maximum (peak) observed concentration following a dose. LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.'}, {'measure': 'Time to Reach Maximum Serum Concentration (Tmax) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'timeFrame': 'Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15', 'description': 'Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.'}, {'measure': 'Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LNA043 (Placebo to ACZ885+LNA043 Versus ACZ885+LNA043)', 'timeFrame': 'Day 15: pre-dose, 20, 60, 120 and 240 minutes, and 8 and 24 hours post LNA043 first injection on Day 15', 'description': 'AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LNA043. LNA043 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8 or higher). LNA043 was determined by a validated immuno-capture and LC-MS/MS method; the anticipated LLOQ is 10 ng/mL in serum.'}, {'measure': 'Change in Cartilage Volume of the Index Region Measured by MRI at Day 197 and Day 365 (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'timeFrame': 'Baseline, Day 197 and Day 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.'}, {'measure': 'Change in Cartilage Volume of the Index Region Measured by MRI at Day 365 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in volume of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.'}, {'measure': 'Change in Cartilage Thickness of the Index Region Measured by MRI at Day 197 and Day 365 (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'timeFrame': 'Baseline, Day 197 and 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in thickness of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.'}, {'measure': 'Change in Cartilage Thickness of the Index Region Measured by MRI at Day 197 and Day 365 (Placebo to ACZ885+LNA043 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 197 and 365', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in thickness of cartilage in the index region. The index region was defined as the union of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.'}, {'measure': 'Change in Synovitis Level Measured From Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI) (ACZ885 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 85', 'description': 'Magnetic resonance images (MRI) were obtained from the target knee with dynamic contrast enhancement (DCE) to visualize and quantify changes in k-trans as a marker of the activity of synovial inflammation. During the DCE-MRI acquisition, while the contrast agent is preferentially taken up at sites with an increased perfusion due to the formation of new vessels with high porosity (such as the inflamed synovial membrane), a temporal variation of the MRI signal intensity occurs. When the contrast distributes through the intravascular and extravascular spaces, the MR signal intensity in the image volume elements (voxels) of the target tissue changes over time, generating so-called signal intensity (SI) curves. These curves can then be analyzed to derive parameters related to tissue perfusion. The parameter of primary interest was the volume transfer rate of the gadolinium-based contrast agent (GBCA) from the blood plasma in synovium, commonly referred to as Ktrans.'}, {'measure': 'Change in Numeric Rating Scale (NRS) Over Time (ACZ885 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85', 'description': 'The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. The scale ranges from 0 (no pain) to 10 (worst possible pain). The NRS Pain instrument had a recall period of 24 hours and the participants were asked to rate the pain intensity at its worst.'}, {'measure': 'Change in Numeric Rating Scale (NRS) Over Time (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85, 197 and 365', 'description': 'The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. The scale ranges from 0 (no pain) to 10 (worst possible pain). The NRS Pain instrument had a recall period of 24 hours and the participants were asked to rate the pain intensity at its worst.'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Over Time (ACZ885 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale."}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Over Time (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85, 197 and 365', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS pain consisting of 9 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale."}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Subscale Over Time (ACZ885 Versus Placebo to ACZ885)', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS Function in Daily Living (ADL) subscale consisting of 17 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale."}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) Subscale Over Time (ACZ885+LNA043 Versus ACZ885, and ACZ885+LNA043 Versus Placebo to ACZ885+LNA043)', 'timeFrame': 'Baseline, Day 15, 29, 43, 57, 71, 85, 197 and 365', 'description': "The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the KOOS Function in Daily Living (ADL) subscale consisting of 17 questions with a recall of 7days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['canakinumab', 'LNA043', 'knee', 'osteoarthritis', 'OA', 'joint pain', 'cartilage', 'MRI', 'DCE-MRI', 'KOOS', 'NRS Pain', 'IPAQ'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2679', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The study was established to show safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).', 'detailedDescription': 'This was a non-confirmatory, randomized, four arm, placebo-controlled, participant-, investigator and sponsor-blinded study in participants with symptomatic knee OA with synovial inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening\n* KOOS pain subscale \\<60 for the target knee during Screening\n* High sensitivity C-reactive Protein (hsCRP) ≥1.8 mg/L\n* Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee\n* Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)\n\nExclusion Criteria:\n\n* History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy \\>50% or osteotomy\n* Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening\n* Malalignment \\>7.5° in the target knee (either varus or valgus)\n* Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)\n* Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period"}, 'identificationModule': {'nctId': 'NCT04814368', 'briefTitle': 'A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (OA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Four-arm, Canakinumab Placebo-controlled, Participant, Investigator and Sponsor-blinded Study Investigating the Safety, Tolerability and Efficacy of Intra-articular Canakinumab Followed by Intra-articular LNA043 in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'CLNA043A12203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo+LNA043', 'description': 'Placebo to canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71', 'interventionNames': ['Biological: LNA043', 'Other: Placebo to canakinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to canakinumab on Day 1', 'interventionNames': ['Other: Placebo to canakinumab']}, {'type': 'EXPERIMENTAL', 'label': 'canakinumab + LNA043', 'description': 'Canakinumab on Day 1 followed by LNA043 on Days 15, 43 and 71', 'interventionNames': ['Biological: canakinumab', 'Biological: LNA043']}, {'type': 'EXPERIMENTAL', 'label': 'canakinumab', 'description': 'Canakinumab on Day 1', 'interventionNames': ['Biological: canakinumab']}], 'interventions': [{'name': 'canakinumab', 'type': 'BIOLOGICAL', 'otherNames': ['ACZ885'], 'description': 'Canakinumab 600 mg single intra-articular injection (into the knee) on Day 1', 'armGroupLabels': ['canakinumab', 'canakinumab + LNA043']}, {'name': 'LNA043', 'type': 'BIOLOGICAL', 'description': 'LNA043 40 mg intra-articular injection (into the knee) every 4 weeks, on Days 15, 43 and 71', 'armGroupLabels': ['Placebo+LNA043', 'canakinumab + LNA043']}, {'name': 'Placebo to canakinumab', 'type': 'OTHER', 'description': 'Placebo to canakinumab single intra-articular injection (into the knee) on Day 1', 'armGroupLabels': ['Placebo', 'Placebo+LNA043']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Horizon Clinical Research', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Res Of W Florida', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Clinical Research LLC', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'LV Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lucas Research', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '19000', 'city': 'Prague', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '6044', 'city': 'Kecskemét', 'state': 'Bács-Kiskun county', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1005', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': '02-677', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'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 study in line with applicable laws and regulations.\n\nThis study data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}