Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01313520
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2011-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)
Sponsor:
Organization:
Raw JSON
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The investigator further agrees to provide to sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor has the right to review and comment on publications, abstracts, slides and manuscripts and on the data analysis and presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion', 'otherNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion', 'otherNumAtRisk': 31, 'otherNumAffected': 8, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 14', 'description': 'Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).', 'unitOfMeasure': 'min ^-1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with infliximab or placebo'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '70.4'}, {'value': '32.3', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '47.0'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 14', 'description': "ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP).", 'unitOfMeasure': 'percentage of responders', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Infliximab or Placebo'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '34.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 14', 'description': "ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP.", 'unitOfMeasure': 'percentage of responders', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Infliximab or placebo'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in DAS28 CRP.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab via intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.18', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '-1.5'}, {'value': '-0.8', 'spread': '0.18', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with infliximab or placebo'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in RAMRIS Synovitis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab via intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.30', 'spread': '4.25', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '1.55'}, {'value': '0.24', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with infliximab or placebo'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in RAMRIS Osteitis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab via intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.10', 'spread': '5.04', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1.5'}, {'value': '0.48', 'spread': '3.22', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '-0.5'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with infliximab or placebo. One participant in the placebo group missing a baseline value was not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.3'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.40', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.87', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': "Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.", 'unitOfMeasure': 'Z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Infliximab or placebo'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-0.2'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.10', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.55', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 14', 'description': "DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual\n\nendpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.", 'unitOfMeasure': 'Z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants treated with Infliximab or placebo'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'saline via intravenous infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '10.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2011-02-25', 'resultsFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-04-25', 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in DAS28 CRP.', 'timeFrame': 'Baseline and Week 14', 'description': 'DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.'}, {'measure': 'Change From Baseline in RAMRIS Synovitis.', 'timeFrame': 'Baseline and Week 14', 'description': 'RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.'}, {'measure': 'Change From Baseline in RAMRIS Osteitis.', 'timeFrame': 'Baseline and Week 14', 'description': 'RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)', 'timeFrame': 'Baseline and week 14', 'description': 'Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).', 'timeFrame': 'Baseline and week 14', 'description': "ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP)."}, {'measure': 'Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).', 'timeFrame': 'Baseline and week 14', 'description': "ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP."}, {'measure': 'Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.', 'timeFrame': 'Baseline and Week 14', 'description': "Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic."}, {'measure': 'Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.', 'timeFrame': 'Baseline and Week 14', 'description': "DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual\n\nendpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '29236711', 'type': 'DERIVED', 'citation': 'Beals C, Baumgartner R, Peterfy C, Balanescu A, Mirea G, Harabagiu A, Popa S, Cheng A, Feng D, Ashton E, DiCarlo J, Vallee MH, Dardzinski BJ. Magnetic resonance imaging of the hand and wrist in a randomized, double-blind, multicenter, placebo-controlled trial of infliximab for rheumatoid arthritis: Comparison of dynamic contrast enhanced assessments with semi-quantitative scoring. PLoS One. 2017 Dec 13;12(12):e0187397. doi: 10.1371/journal.pone.0187397. eCollection 2017.'}, {'pmid': '25504080', 'type': 'DERIVED', 'citation': 'MacIsaac KD, Baumgartner R, Kang J, Loboda A, Peterfy C, DiCarlo J, Riek J, Beals C. Pre-treatment whole blood gene expression is associated with 14-week response assessed by dynamic contrast enhanced magnetic resonance imaging in infliximab-treated rheumatoid arthritis patients. PLoS One. 2014 Dec 12;9(12):e113937. doi: 10.1371/journal.pone.0113937. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to compare the effect of infliximab versus placebo on synovial inflammation as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is that over 14 weeks of therapy, the change from baseline in the volume transfer rate in enhancing synovium is larger due to treatment with infliximab than with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a clinical diagnosis of rheumatoid arthritis for at least 6 months\n* Must have at least 6 tender joints AND 6 swollen joints\n* Has a C-reactive protein ≥ 1.0 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr\n* Baseline MRI must show evidence of synovitis in the wrist\n* Must have screening laboratory tests within acceptable levels\n* Women of childbearing potential and all men must agree to use a medically accepted method of contraception prior to entering the study and continue throughout study up to 6 weeks after study completion\n* Must meet tuberculosis (TB) screening criteria\n* Have received methotrexate therapy for ≥ 3 months; dose must be stable for at least 8 weeks\n* If taking the a disease modifying anti-rheumatic drug (DMARD) in combination with methotrexate must be on a stable dose\n* Must have a clinically acceptable 12 lead electrocardiogram (ECG)\n* If taking oral corticosteroids must be on a stable dose equivalent to ≤10 mg of prednisone (or prednisolone) per day for ≥2 weeks\n* If taking daily non-steroidal anti-inflammatory drug (NSAID) must be on a stable dose for ≥2 weeks; if taking NSAID on an as-needed basis must agree to discontinue use for at least 3 days and use only acetaminophen for breakthrough pain for 3 days before each MRI and clinic visit\n* If received biological therapies, the last dose of these drugs was to be received ≥ 3 months prior to the baseline visit AND the reason for discontinuations was not for safety considerations OR lack of efficacy\n\nExclusion Criteria:\n\n* Are pregnant, intend to become pregnant, or are breastfeeding\n* Has inflammatory arthritis other than RA\n* Has uncontrolled hypertension\n* Has moderate or severe congestive heart failure\n* Has a history of or current signs and/or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease\n* Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis\n* Is currently participating in another clinical study or have participated in a clinical study (e.g., laboratory or clinical evaluation) within 4 weeks\n* Has history of any tumor with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix\n* Has a history of any latent or active granulomatous infection including histoplasmosis, or coccidiomycosis\n* Had a non-tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months\n* Has a history of an infected joint prosthesis which has not been removed or replaced\n* Has a known hypersensitivity to human immunoglobulin proteins or other components of infliximab\n* Has received rituximab or natalizumab\n* Has known claustrophobia or other contraindication to MRI\n* Does not meet washout period guidelines for previous treatments/injections/vaccinations'}, 'identificationModule': {'nctId': 'NCT01313520', 'briefTitle': 'A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)', 'orgStudyIdInfo': {'id': 'P08136'}, 'secondaryIdInfos': [{'id': '2011-000079-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infliximab', 'description': '3 mg/kg of Infliximab intravenous infusion', 'interventionNames': ['Drug: Infliximab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'saline via intravenous infusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['SCH 215596', 'Remicade'], 'description': '3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion', 'armGroupLabels': ['Infliximab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}