Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-11 @ 11:46 PM
Study NCT ID:
NCT01299961
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
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': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vranganath@mednet.ucla.edu', 'phone': '310-825-3061', 'title': 'Veena K. Ranganath, MD, MS Assistant Clinical Professor', 'organization': 'UCLA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a very small open-label study of 25 patients on a FDA approved drug, where efficacy (by standard validated measures) and safety were not the primary end points.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '13.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '11.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.1', 'groupDescription': 'Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 months', 'description': 'The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 19 patients completed 12 mos'}, {'type': 'SECONDARY', 'title': '12 Month Change in Power Doppler Ultrasound (PDUS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.7', 'groupDescription': '7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 months', 'description': 'There were seven different joints in the hands and wrists evaluated to score the PDUS.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As stated previously'}, {'type': 'SECONDARY', 'title': '12 Month Change in Gray-scale Ultrasound (GSUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.19', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.7', 'groupDescription': '7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 months', 'description': 'There were seven different joints in the hands and wrists evaluated to score the GSUS.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 34 RA patients were recruited from the UCLA rheumatology clinics between September 2011 to February 2013. However, we had a total of 9 screen fails.', 'preAssignmentDetails': 'Patients enrolled in the study were required to have RA, on stable RA medications, and naive to abatacept.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '13.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This is a the average age of the cohort that started the mediation, Abatacept 125mg sq qwk.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-15', 'studyFirstSubmitDate': '2011-02-18', 'resultsFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-20', 'studyFirstPostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score', 'timeFrame': 'baseline, 12 months', 'description': 'The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.'}], 'secondaryOutcomes': [{'measure': '12 Month Change in Power Doppler Ultrasound (PDUS) Scores', 'timeFrame': 'baseline, 12 months', 'description': 'There were seven different joints in the hands and wrists evaluated to score the PDUS.'}, {'measure': '12 Month Change in Gray-scale Ultrasound (GSUS)', 'timeFrame': 'baseline, 12 months', 'description': 'There were seven different joints in the hands and wrists evaluated to score the GSUS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Subcutaneous Abatacept', 'Ultrasound'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '36828925', 'type': 'DERIVED', 'citation': 'Charles-Schoeman C, Wang J, Shahbazian A, Wilhalme H, Brook J, Kaeley GS, Oganesian B, Ben-Artzi A, Elashoff DA, Ranganath VK. Power doppler ultrasound signal predicts abnormal HDL function in patients with rheumatoid arthritis. Rheumatol Int. 2023 Jun;43(6):1041-1053. doi: 10.1007/s00296-023-05285-7. Epub 2023 Feb 24.'}]}, 'descriptionModule': {'briefSummary': "Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.\n\nThe purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 18 years old\n2. Has a diagnosis of rheumatoid arthritis\n3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)\n4. Disease activity score DAS28/ESR \\> 3.2 or all must be met: TJC (tender joint count)\\>=4, SJC (swollen joint count)\\>=4\n5. Must be able to understand information in the Informed Consent and comply with study requirements\n6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score \\>=1 for at least 2 joints and total synovitis score \\>=1 for at least 1 joint\n\nExclusion Criteria:\n\n1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)\n2. Pregnancy or breast feeding\n3. Daily prednisone \\> 10mg (stable dose for at least 1 month)\n4. Intra-articular steroid injection of the wrist or joints within last 2 months\n5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis\n6. History of cancer\n7. Previous exposure to abatacept'}, 'identificationModule': {'nctId': 'NCT01299961', 'briefTitle': 'Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'UCLA Rheumatology RA 001'}, 'secondaryIdInfos': [{'id': 'IND 111281', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subcutaneous Abatacept', 'description': 'All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.', 'interventionNames': ['Drug: abatacept']}], 'interventions': [{'name': 'abatacept', 'type': 'DRUG', 'description': '125 mg once a week up to 12 months.', 'armGroupLabels': ['Subcutaneous Abatacept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA David Geffen School of Medicine, Division of Rheumatology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Veena K Ranganath, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA David Geffen School of Medicine, Division of Rheumatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Assistant Clinical Professor', 'investigatorFullName': 'Dr. Veena Ranganath', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}