Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02109666
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Experience With Abatacept in Routine Clinical Practice
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': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Whole blood (Spanish sub study only)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-17', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice', 'timeFrame': 'Up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Major determinants of treatment discontinuation of RA patients treated with Abatacept', 'timeFrame': 'Up to 24 months', 'description': 'Major determinants including prior RA treatment experience with biologics and clinical outcomes, such as Disease Activity Score 28 (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and their derived criteria'}, {'measure': 'Distribution of time-to-discontinuation of Abatacept therapy for each major determinant of treatment discontinuation, overall and depending on the treatment line', 'timeFrame': 'Up to 24 months'}, {'measure': "Association of prior RA treatment experience and clinical outcomes during the treatment course with patient reported outcomes (Patient satisfaction, Pain, Patient's Global Assessment)", 'timeFrame': 'Up to 24 months'}, {'measure': 'Summary of treatment experience and outcomes after switching to a biologic or conventional Disease Modifying Anti-Rheumatic Drugs (DMARD) for patients who discontinue Abatacept therapy', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '39893489', 'type': 'DERIVED', 'citation': 'Alten R, Behar C, Merckaert P, Afari E, Vannier-Moreau V, Ohayon A, Connolly SE, Najm A, Juge PA, Liu G, Rai A, Elbez Y, Lozenski K. Predicting abatacept retention using machine learning. Arthritis Res Ther. 2025 Feb 1;27(1):20. doi: 10.1186/s13075-025-03484-0.'}, {'pmid': '30790095', 'type': 'DERIVED', 'citation': 'Alten R, Mariette X, Lorenz HM, Nusslein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Poncet C, Rauch C, Le Bars M. Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study. Clin Rheumatol. 2019 May;38(5):1413-1424. doi: 10.1007/s10067-019-04449-w. Epub 2019 Feb 21.'}, {'pmid': '29435360', 'type': 'DERIVED', 'citation': 'Alten R, Mariette X, Lorenz HM, Galeazzi M, Cantagrel A, Nusslein HG, Chartier M, Elbez Y, Rauch C, Le Bars M. Real-world predictors of 12-month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study. RMD Open. 2017 Dec 29;3(2):e000538. doi: 10.1136/rmdopen-2017-000538. eCollection 2017.'}, {'pmid': '29329602', 'type': 'DERIVED', 'citation': 'Alten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.'}, {'pmid': '28243468', 'type': 'DERIVED', 'citation': 'Alten R, Nusslein HG, Mariette X, Galeazzi M, Lorenz HM, Cantagrel A, Chartier M, Poncet C, Rauch C, Le Bars M. Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naive: 6-month results from a real-world, international, prospective study. RMD Open. 2017 Feb 13;3(1):e000345. doi: 10.1136/rmdopen-2016-000345. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the retention rate of Abatacept over 24 months in routine clinical practice in every participating country depending on the treatment line.', 'detailedDescription': 'Time Perspective: Other: Collection of the baseline data collected at Abatacept IV initiation, prospectively or retrospectively within maximum 3 months following the first administration. Other assessments are collected during the follow up period (maximum of 2 years by patient)\n\nBiospecimen Retention: None Retained excepted for a local sub study (in Spain) where sample with DNA was retained'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Crohn's Disease", 'healthyVolunteers': False, 'eligibilityCriteria': "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Male or Female subjects of more than 18 years old\n* Patients with a diagnosis of established moderate to severe active RA (as per the American College of Rheumatology revised criteria, 1987), who at their physician's discretion are treated with Abatacept according to the SmPC in Europe and the Product Monograph in Canada (initiating or already on treatment for maximum 3 months) and for whom baseline characteristics are available\n\nExclusion Criteria:\n\n* Patients who are currently included in any interventional clinical trial in RA"}, 'identificationModule': {'nctId': 'NCT02109666', 'acronym': 'ACTION', 'briefTitle': 'Long Term Experience With Abatacept in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Long Term Experience With Abatacept in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'IM101-151'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA patients treated with Abatacept', 'description': 'RA patients are treated with Abatacept IV according Summary of Product Characteristics (SmPC) in Europe and Product Monograph in Canada', 'interventionNames': ['Drug: Abatacept']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia'], 'armGroupLabels': ['RA patients treated with Abatacept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'A1B3E1', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '64120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '71 201', 'city': 'Crete', 'country': 'Greece', 'facility': 'Local Institution'}, {'zip': '4', 'city': 'Dublin', 'state': 'Dublin', 'country': 'Ireland', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '1056 AB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '41071', 'city': 'Seville', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '4055', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}