Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 1:36 PM
Study NCT ID:
NCT00929357
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2009-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 48 months', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study. No safety evaluation was performed nor intended; no events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.', 'otherNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'title': 'Baseline Ratingen score - first radiograph', 'categories': [{'measurements': [{'value': '6.9', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '30.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at second radiograph', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Annualized change in Ratingen score', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, \\<20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = \\>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 \\[months\\])\\*12 months.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Without Radiographic Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = \\>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Without Erosions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population. Ratingen scores were calculated based on radiographic assessment, but score of 0 (no erosions) was not reported separately; data not summarized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'title': 'Baseline DAS 28 - first radiograph (n=85, 61)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at second radiograph (n=83, 58)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': "DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'title': 'Baseline ESR - first radiograph (n=91, 63)', 'categories': [{'measurements': [{'value': '23.8', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at second radiograph (n=90, 63)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).', 'unitOfMeasure': 'mm/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'title': 'Baseline CRP- first radiograph (n=90, 64)', 'categories': [{'measurements': [{'value': '12.9', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at second radiograph (n=89, 64)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'C-reactive protein measured as milligrams per liter (mg/l)', 'unitOfMeasure': 'mg/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Rheumatoid Factor (RF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'title': 'Baseline Positive RF- first radiograph (n=89, 62)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Negative RF- first radiograph', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Positive RF at second radiograph (n=85, 61)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Negative RF at second radiograph', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Rheumatoid Factor measured as a titer and categorized as negative (\\<1:16 ratio) or positive. A ratio \\>1:16 indicates a higher level of RF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population; (n)=number of participants with analyzable data at observation for Positive or Negative status for DMARDS and Biologics, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'OG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'classes': [{'title': 'Positive CCP', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Negative CCP', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (\\<20 EU) or positive (≥20 up to \\>60 EU).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population; N=number of participants with evaluable data for CCP. CCP value as a laboratory diagnostic marker was collected within the complete timeframe and was documented only once; calculation for change in value not applicable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'FG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 160 participants were screened and 156 entered this non-randomized retrospective evaluation of conventional systemic therapies and biologics in participants with rheumatoid arthritis in routine practice.', 'preAssignmentDetails': 'Participants had been treated according to authorized dosages for disease-modifying anti-rheumatic drug (DMARDs) and biologics in Germany. No investigational product had been provided.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DMARDS', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.'}, {'id': 'BG001', 'title': 'Biologics', 'description': 'Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '13.1', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2009-06-25', 'resultsFirstSubmitDate': '2011-06-06', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-06', 'studyFirstPostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, \\<20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = \\>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 \\[months\\])\\*12 months.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Without Radiographic Progression', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = \\>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.'}, {'measure': 'Number of Participants Without Erosions', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.'}, {'measure': 'Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': "DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hour\\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity."}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).'}, {'measure': 'Change From Baseline in C-reactive Protein (CRP)', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'C-reactive protein measured as milligrams per liter (mg/l)'}, {'measure': 'Number of Participants With Change From Baseline in Rheumatoid Factor (RF)', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Rheumatoid Factor measured as a titer and categorized as negative (\\<1:16 ratio) or positive. A ratio \\>1:16 indicates a higher level of RF.'}, {'measure': 'Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)', 'timeFrame': 'Baseline (Day 0) up to 48 months', 'description': 'Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (\\<20 EU) or positive (≥20 up to \\>60 EU).'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Secure diagnosis of rheumatoid arthritis\n* Older than 18 years\n* Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.\n\nExclusion Criteria:\n\n\\- Patients who receive Anakinra, Rituximab or Abatacept'}, 'identificationModule': {'nctId': 'NCT00929357', 'briefTitle': 'Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.', 'orgStudyIdInfo': {'id': '0881X1-4617'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'DMARDs', 'interventionNames': ['Drug: DMARDs or Biologics']}, {'label': '2', 'description': 'Biologics', 'interventionNames': ['Drug: DMARDs or Biologics']}], 'interventions': [{'name': 'DMARDs or Biologics', 'type': 'DRUG', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48155', 'city': 'Schmittingheide 20-32', 'state': 'Munster', 'country': 'Denmark'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Wyeth'}}}}