Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-18 @ 12:53 PM
Study NCT ID:
NCT03331393
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 265}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients discontinuing treatment before completing 12 months of therapy', 'timeFrame': 'approximately 1 year'}, {'measure': 'time from treatment initiation to discontinuation', 'timeFrame': 'approximately 1 year'}], 'secondaryOutcomes': [{'measure': 'Distribution of Healthcare Resource Utilization (HCRU)', 'timeFrame': 'approximately 1 year'}, {'measure': 'Disease Activity Score', 'timeFrame': 'approximately 1 year', 'description': 'Disease Activity Score (DAS)'}, {'measure': 'Health Assessment Questionnaire', 'timeFrame': 'approximately 1 year', 'description': 'Health Assessment Questionnaire (HAQ)'}, {'measure': 'C-reactive Protein Levels', 'timeFrame': 'approximately 1 year', 'description': 'C-reactive protein (CRP) levels'}, {'measure': 'Erythrocyte Sedimentation Rate', 'timeFrame': 'approximately 1 year', 'description': 'Erythrocyte sedimentation rate (ESR) levels'}, {'measure': 'Joint Erosions', 'timeFrame': 'approximately 1 year', 'description': 'Measured by radiographic reports'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age at enrollment\n* Confirmed diagnosed with RA\n* Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site\n\nExclusion Criteria:\n\n* Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels\n* Was followed at the site for less than 1 year since biologic treatment initiation\n* Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula\n\nOther protocol defined inclusion/exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT03331393', 'briefTitle': 'The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study', 'orgStudyIdInfo': {'id': 'IM101-686'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA patients treated with Abatacept', 'description': 'Treated with Abatacept as a first-line biologic', 'interventionNames': ['Other: Non-interventional']}, {'label': 'RA patients treated with TNFi', 'description': 'Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic', 'interventionNames': ['Other: Non-interventional']}], 'interventions': [{'name': 'Non-interventional', 'type': 'OTHER', 'description': 'Non-interventional', 'armGroupLabels': ['RA patients treated with Abatacept', 'RA patients treated with TNFi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Local Institution - 0005', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '83814-2644', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '55121', 'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Medication Management, LLC', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '99352', 'city': 'Richland', 'state': 'Washington', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 46.28569, 'lon': -119.28446}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}