Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-31 @ 6:34 PM
Study NCT ID:
NCT01782469
Status:
TERMINATED
Last Update Posted:
2015-07-30
First Post:
2013-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013585', 'term': 'Synovitis'}], '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': {'phone': '800-633-9110', 'title': 'Global Medical Information', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events were collected from the time of informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment, up to 18 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.6', 'spread': '4.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data'}, {'type': 'SECONDARY', 'title': 'Mean Percent Reduction in Ultrasonography Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'classes': [{'title': 'Visit 2, n=16', 'categories': [{'measurements': [{'value': '-20.99', 'spread': '18.4', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3, n=16', 'categories': [{'measurements': [{'value': '-35.60', 'spread': '25.36', 'groupId': 'OG000'}]}]}, {'title': 'Visit 4, n=16', 'categories': [{'measurements': [{'value': '-48.42', 'spread': '19.88', 'groupId': 'OG000'}]}]}, {'title': 'Visit 5, n=15', 'categories': [{'measurements': [{'value': '-56.91', 'spread': '24.81', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.', 'unitOfMeasure': 'Percent reduction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data'}, {'type': 'SECONDARY', 'title': 'Mean Number of Joints With Detected Erosions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'classes': [{'title': 'Visit 1, n=16', 'categories': [{'measurements': [{'value': '9.38', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2, n=16', 'categories': [{'measurements': [{'value': '8.69', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3, n=16', 'categories': [{'measurements': [{'value': '7.69', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Visit 4, n=16', 'categories': [{'measurements': [{'value': '6.75', 'spread': '3.24', 'groupId': 'OG000'}]}]}, {'title': 'Visit 5, n=15', 'categories': [{'measurements': [{'value': '6.07', 'spread': '2.91', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.130', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)', 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'classes': [{'categories': [{'measurements': [{'value': '93.75', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '107.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Mean Change in Health Assessment Questionnaire (HAQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \\< 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rheumatoid Arthritis (RA) Participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '9.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Study stopped due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-02', 'studyFirstSubmitDate': '2013-01-31', 'resultsFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2013-01-31', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-02', 'studyFirstPostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Reduction in Ultrasonography Assessment Score', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.'}, {'measure': 'Mean Number of Joints With Detected Erosions', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.'}, {'measure': 'Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).'}, {'measure': 'Mean Change in Health Assessment Questionnaire (HAQ) Score', 'timeFrame': 'Baseline (Visit 1) to 13 weeks', 'description': 'The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \\< 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Synovitis', 'Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.', 'detailedDescription': 'This study was a prospective, observational, single arm, multicenter study. Participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. A total of 5 visits were planned: Baseline (Visit 1), Visits 2, 3, 4 and 5 (Week 13). The time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. Additional study objectives were to investigate the rate of RA progression via changes in the B-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. The study was terminated due to low enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Private clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA patient will be enrolled in this study if he/she fulfills ALL of the following criteria:\n\n* Male or Female patients ≥ 18 years of age with diagnosis of RA\n* Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines\n* Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study\n* Patient has no history of inflammatory arthritis other than rheumatoid arthritis\n* Patient has no history of lymphoma or leukemia or other malignancies\n* Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations\n\nExclusion Criteria:\n\n* Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria\n* Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression\n* Susceptibility to infections including TB, as judged by the investigator\n* Patient is carrier of Hepatitis B virus\n* Patient is a pregnant or lactating female at the time of screening'}, 'identificationModule': {'nctId': 'NCT01782469', 'briefTitle': 'Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Prospective, Multi-center Study in Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population', 'orgStudyIdInfo': {'id': 'P13-708'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis (RA) participants', 'description': 'Male or female participants at least 18 years of age with diagnosis of RA'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Iman Ibrahim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}