Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 3:48 PM
Study NCT ID:
NCT01618968
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2012-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjaffe@antarespharma.com', 'phone': '609-359-3020', 'title': 'Jonathan Jaffe, MD; Vice President Clinical Development', 'phoneExt': '324', 'organization': 'Antares Pharma Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The Safety Population was defined as all randomized subjects who received at least 1 dose of study drug. The Safety Population included 49 subjects.', 'description': 'Adverse events were classified by treatment at onset. Any adverse event that occurred on Day 1 (after check-in) for a given treatment period was assigned to the treatment for that period.', 'eventGroups': [{'id': 'EG000', 'title': '10mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '15mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '20mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '25mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea (20 mg MTX Oral)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue (10 mg Vibex MTX SC Thigh)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rheumatoid Arthritis (10 mg Vibex MTX SC Abdomen)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Sick Sinus Syndrome (15 mg Vibex MTX SC Thigh)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myocardial Infarction (25 mg Vibex MTX SC Abdomen)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-Normalized AUC[0-Inf] for MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Oral Methotrexate (MTX) Tablets'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'SC injection of Vibex MTX into the Abdomen'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'SC injection of Vibex MTX into the Thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '109.47', 'spread': '39.19', 'groupId': 'OG000'}, {'value': '140.84', 'spread': '46.66', 'groupId': 'OG001'}, {'value': '136.45', 'spread': '46.675', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test / Reference Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '127.99', 'ciLowerLimit': '121.61', 'ciUpperLimit': '134.70', 'groupDescription': 'To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioavailability comparisons were performed at each dose level.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test / Reference Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '125.48', 'ciLowerLimit': '119.43', 'ciUpperLimit': '131.84', 'groupDescription': 'To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioavailability comparisons were performed at each dose level.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test / Reference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.85', 'ciLowerLimit': '99.41', 'ciUpperLimit': '104.36', 'groupDescription': 'To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Test of bioequivalence was performed at each dose level.'}], 'paramType': 'MEAN', 'timeFrame': '24 Hour period', 'description': 'Dose-normalized area under the curve from time zero to infinity (AUC\\[0-inf\\]/Dose) for each treatment', 'unitOfMeasure': 'ng*hr/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.'}, {'type': 'PRIMARY', 'title': 'Dose-Normalized AUC[0-24] for MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Oral Methotrexate (MTX) Tablets'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'SC injection of Vibex MTX into the Abdomen'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'SC injection of Vibex MTX into the Thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '107.64', 'spread': '37.732', 'groupId': 'OG000'}, {'value': '137.88', 'spread': '44.513', 'groupId': 'OG001'}, {'value': '133.78', 'spread': '44.406', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test / Reference Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '127.65', 'ciLowerLimit': '121.28', 'ciUpperLimit': '134.36', 'groupDescription': 'To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioavailability comparisons were performed at each dose level.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test / Reference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '125.20', 'ciLowerLimit': '119.16', 'ciUpperLimit': '131.55', 'groupDescription': 'To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioavailability comparisons were performed at each dose level.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test / Reference Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.82', 'ciLowerLimit': '99.39', 'ciUpperLimit': '104.31', 'groupDescription': 'To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Test of bioequivalence was performed at each dose level.'}], 'paramType': 'MEAN', 'timeFrame': '24 Hour period', 'description': 'Dose-normalized area under the curve from time zero to 24 hours (AUC\\[0-24\\]/Dose) for each treatment', 'unitOfMeasure': 'ng*hr/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.'}, {'type': 'PRIMARY', 'title': 'Dose-Normalized Cmax for MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Oral Methotrexate (MTX) Tablets'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'SC injection of Vibex MTX into the Abdomen'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'SC injection of Vibex MTX into the Thigh'}], 'classes': [{'categories': [{'measurements': [{'value': '22.697', 'spread': '7.496', 'groupId': 'OG000'}, {'value': '21.935', 'spread': '8.243', 'groupId': 'OG001'}, {'value': '18.436', 'spread': '5.321', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test / Reference ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.83', 'ciLowerLimit': '86.42', 'ciUpperLimit': '104.06', 'groupDescription': 'To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioavailability comparisons were performed at each dose level.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test / Reference Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '82.12', 'ciLowerLimit': '76.16', 'ciUpperLimit': '88.55', 'groupDescription': 'To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioavailability comparisons were performed at each dose level.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test / Reference Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '115.63', 'ciLowerLimit': '108.83', 'ciUpperLimit': '122.86', 'groupDescription': 'To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Test of bioequivalence was performed at each dose level.'}], 'paramType': 'MEAN', 'timeFrame': '24 Hour period', 'description': 'Dose-normalized maximum observed concentration (Cmax) for each treatment', 'unitOfMeasure': 'ng/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '10mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'FG001', 'title': '15mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'FG002', 'title': '20mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'FG003', 'title': '25mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Received Treatment A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Received Treatment B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Received Treatment C', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Subjects were screened and enrolled at 4 sites in the US. Approximately equal number of subjects on 10 mg, 15 mg, 20 mg and 25 mg doses were recruited. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The subject's dose was the same for the entire study", 'preAssignmentDetails': 'MTX was administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C within the same dose group. Treatments were administered at a 7 day interval (On study days 1, 8 and 15)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '10mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'BG001', 'title': '15mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'BG002', 'title': '20mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'BG003', 'title': '25mg MTX', 'description': '\\[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh\\]'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '12.51', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '7.49', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '10.40', 'groupId': 'BG002'}, {'value': '59.0', 'spread': '11.53', 'groupId': 'BG003'}, {'value': '61.4', 'spread': '10.53', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'In total, 50 subjects were randomized, of which 49 were included in the safety population. Of 49, 47 completed the study and 2 discontinued from the study after first dose.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2012-06-04', 'resultsFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2012-06-12', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-09', 'studyFirstPostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Normalized AUC[0-Inf] for MTX', 'timeFrame': '24 Hour period', 'description': 'Dose-normalized area under the curve from time zero to infinity (AUC\\[0-inf\\]/Dose) for each treatment'}, {'measure': 'Dose-Normalized AUC[0-24] for MTX', 'timeFrame': '24 Hour period', 'description': 'Dose-normalized area under the curve from time zero to 24 hours (AUC\\[0-24\\]/Dose) for each treatment'}, {'measure': 'Dose-Normalized Cmax for MTX', 'timeFrame': '24 Hour period', 'description': 'Dose-normalized maximum observed concentration (Cmax) for each treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis (RA)']}, 'referencesModule': {'references': [{'pmid': '24728329', 'type': 'DERIVED', 'citation': 'Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014 Aug;73(8):1549-51. doi: 10.1136/annrheumdis-2014-205228. Epub 2014 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'Relative Bioavailability Comparison study', 'detailedDescription': 'A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis\n\nExclusion Criteria:\n\n* Pregnant females\n* Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk'}, 'identificationModule': {'nctId': 'NCT01618968', 'briefTitle': 'Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Antares Pharma Inc.'}, 'officialTitle': 'Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'MTX-11-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mg Methotrexate (MTX)', 'description': "MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.", 'interventionNames': ['Drug: MTX']}, {'type': 'EXPERIMENTAL', 'label': '15 mg MTX', 'description': "MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.", 'interventionNames': ['Drug: MTX']}, {'type': 'EXPERIMENTAL', 'label': '20 mg MTX', 'description': "MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.", 'interventionNames': ['Drug: MTX']}, {'type': 'EXPERIMENTAL', 'label': '25 mg MTX', 'description': "MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned.", 'interventionNames': ['Drug: MTX']}], 'interventions': [{'name': 'MTX', 'type': 'DRUG', 'otherNames': ['Commercially available 2.5 mg MTX oral tablets', 'VIBEX MTX'], 'description': "* Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group)\n* Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)\n* Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)", 'armGroupLabels': ['10 mg Methotrexate (MTX)', '15 mg MTX', '20 mg MTX', '25 mg MTX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}], 'overallOfficials': [{'name': 'Alan J Kivitz, MD;CPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altoona Center for Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antares Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}