Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT01694693
Status:
WITHDRAWN
Last Update Posted:
2017-05-10
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study
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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business objectives have changed', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with first clinically significant Disease Activity Score (DAS) change', 'timeFrame': 'Up to 5 Years', 'description': 'Change from DAS28 \\[C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)\\] measured at treatment initiation ≥ 1.2\n\nDAS28 will be measured every 6 months during 5 years'}, {'measure': 'Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]', 'timeFrame': 'Up to 5 Years', 'description': 'EULAR response will be measured every 6 months during 5 years'}, {'measure': 'Number of patients with first Low Disease Activity State (LDAS)', 'timeFrame': 'Up to 5 Years', 'description': 'Change from DAS28 \\[C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)\\] measured at treatment initiation ≤ 3.2\n\nDAS28 will be measured every 6 months during 5 years'}, {'measure': 'Number of patients with first Remission state', 'timeFrame': 'Up to 5 Years', 'description': 'Change from DAS28 \\[C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)\\] measured at treatment initiation \\<2.6\n\nDAS28 will be measured every 6 months during 5 years'}, {'measure': 'Number of patients disease progression with prior improvement', 'timeFrame': 'Up to 5 Years'}, {'measure': 'Number of patients disease progression with no prior improvement', 'timeFrame': 'Up to 5 Years'}, {'measure': 'Number of patients with modification of Orencia administration condition', 'timeFrame': 'Up to 5 Years'}, {'measure': 'Number of patients discontinued and switched from Orencia', 'timeFrame': 'Up to 5 Years'}, {'measure': 'Incidence rate of any type of Adverse events related to Orencia', 'timeFrame': 'Up to 5 Years'}, {'measure': 'Number of patients with specific predefined events', 'timeFrame': 'Up to 5 Years', 'description': 'Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death'}, {'measure': 'Response over the time will be assessed over 5 years on EULAR response, LDAS', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'Database analysis:\n\n* To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)\n* To describe joint population of Orencia\n* To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria\n* To describe therapeutic strategies and use of health services', 'detailedDescription': "* Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry\n* Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA\n* Minimum Age: 18 years old at Orencia initiation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients included in SFR's ORA Registry", 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* Adult outpatients, male or female aged ≥ 18 years old\n* Diagnosed with a rheumatoid arthritis according to ACR criteria\n* Treated with Orencia according to usual practice conditions from June 1st 2007\n* Agreeing to participate\n\nExclusion Criteria:\n\n* Patients treated by Orencia in the context of clinical trials'}, 'identificationModule': {'nctId': 'NCT01694693', 'briefTitle': "Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': "Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study", 'orgStudyIdInfo': {'id': 'IM101-364'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA patients treated by Orencia', 'description': 'RA patients treated by Orencia according to usual practice from June 1st 2007', 'interventionNames': ['Drug: Orencia']}], 'interventions': [{'name': 'Orencia', 'type': 'DRUG', 'description': 'No Intervention', 'armGroupLabels': ['RA patients treated by Orencia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}