Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02090556
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Experience With Abatacept SC 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2954}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment experience and outcomes after Abatacept discontinuation and switch to a biologic agent or conventional disease modifying anti-rheumatismal drug (DMARD)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Build and validate a multigenic predictive model of abatacept clinical response in two different populations of abatacept patients (MTX-IR and anti TNF-IR) (in Spain)', 'timeFrame': 'Up to 24 months'}, {'measure': "Examine how patients self-reporting related to main ASCORE study treatment decisions and explore patients'acceptability of self-monitoring using qualitative methods (ART substudy, in the UK)", 'timeFrame': 'Up to 24 months'}, {'measure': 'Patient-reported elements which are most likely to lead to change in therapy (in the UK)', 'timeFrame': 'Up to 24 months'}], 'primaryOutcomes': [{'measure': 'Key Primary: Median time and estimation of treatment retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept subcutaneous (SC) over 24 months in routine clinical practices', 'timeFrame': 'Up to 24 Months'}, {'measure': 'Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort', 'timeFrame': 'Up to 24 Months', 'description': 'Description include concomitant treatments, dosage and adherence to treatment'}, {'measure': 'Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation', 'timeFrame': 'Up to 24 Months', 'description': 'Major characteristics of population of patients (joint population depending on previous prescriptions) include socio-demographic data, medical history, disease history, co-morbidities and clinical measures'}, {'measure': 'Co-Primary: Impact of the Abatacept SC treatment on health status of each population of patients over time as assessed by morbi-mortality criteria and safety', 'timeFrame': 'Up to 24 Months', 'description': 'Morbi-mortality criteria include clinical measures, Patient Reported Outcomes (PRO) including self-completion quality of life (QoL) questionnaires and healthcare resource use, incidence of local site injection reaction, incidence of long-term adverse events (AE), withdrawal from study due to AE and Serious Adverse Events (SAE)'}, {'measure': 'Co-Primary: Acceptability of the pre-filled pen device based on questionnaires', 'timeFrame': 'Up to 24 Months', 'description': 'Patients using the pre-filled pen will complete questionnaires on overall acceptability of the pre-filled pen device, injection site pain assessment and experience with previous injections'}], 'secondaryOutcomes': [{'measure': 'Major determinants of Abatacept SC retention rate', 'timeFrame': 'Up to 24 months', 'description': 'Major determinants including socio-demographic characteristics at treatment initiation, previous biologic treatments, clinical measurements (i.e. Simplified Disease Activity Score based on 28 joints (DAS28), Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI) and their derived criteria) and PROs such as Health Assessment Questionnaire Disability Index (HAQ-DI) and according to local clinical practices and/or according to local requirements Work Productivity and Activity Impairment Questionnaire:Rheumatoid Arthritis (WPAI:RA), Rheumatoid Arthritis Disease Activity Index (RADAI) or PRO-CLinical Arthritis Activity (PROCLARA) at treatment initiation and/or at studied drug discontinuation'}, {'measure': 'Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified', 'timeFrame': 'Up to 24 months'}, {'measure': 'Time to discontinuation of Abatacept (whatever the formulation, SC or IV)', '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': '37314665', 'type': 'DERIVED', 'citation': 'Alten R, Tony HP, Bannert B, Nusslein H, Rauch C, Connolly SE, Chartier M, Lozenski K, Hackl R, Forster A, Peichl P. Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus. Clin Rheumatol. 2023 Sep;42(9):2321-2334. doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.'}, {'pmid': '35536413', 'type': 'DERIVED', 'citation': 'Alten R, Mariette X, Flipo RM, Caporali R, Buch MH, Patel Y, Marsal S, Sanmarti R, Nurmohamed MT, Griffiths H, Peichl P, Bannert B, Chartier M, Connolly SE, Lozenski K, Rauch C. Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study. Clin Rheumatol. 2022 Aug;41(8):2361-2373. doi: 10.1007/s10067-022-06176-1. Epub 2022 May 10.'}], 'seeAlsoLinks': [{'url': 'http://bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'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 SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Corhort 1: RA patients naive of Abatacept and any other biologic agents.\n\nCorhort 2: RA patients naïve of Abatacept and who previously failed one or more biologic agents.\n\nIn Germany, the study will be proposed to patients using syringe or pre-filled pen devices', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥18 years old at treatment initiation\n* Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Rheumatoid Arthritis Classification Criteria\n* Patients naïve of Abatacept IV and who at their physician's discretion are initiated with Abatacept SC. In countries where required (e.g. Germany and Spain), patients naïve of Abatacept IV and who at their physician's discretion have been initiated with Abatacept SC at least 1 month prior to enrollment visit up to 6 months if baseline and disease characteristics data are available\n* For Spanish pharmacogenomic sub-study:\n* Caucasian patient and from European ancestry\n* Patient for whom a collection of blood sample before the initiation of abatacept is possible or available (blood sample was taken in routine practice before the study enrolment)\n* Patient who agreed to participate in this substudy and provide a specific signed Pharmacogenomic Blood RNA informed consent\n* In the UK, the ART substudy will be proposed to all patients enrolled in ASCORE from amendment approval and application date\n\nExclusion Criteria:\n\n\\- Patients who are currently included in any interventional clinical trial in RA"}, 'identificationModule': {'nctId': 'NCT02090556', 'acronym': 'ASCORE', 'briefTitle': 'Long-term Experience With Abatacept SC in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Long-term Experience With Abatacept SC in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'IM101-348'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1:', 'description': 'RA patients naive of Abatacept and any other biologic agents'}, {'label': 'Cohort 2:', 'description': 'RA patients naive of Abatacept and who previously failed one or more biologic agents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': 'A-1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': 'D-01067', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '71110', 'city': 'Crete', 'country': 'Greece', 'facility': 'Local Institution'}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '98012', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}, {'zip': '1056 AB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8253', 'city': 'Diessenhofen', 'country': 'Switzerland', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.68908, 'lon': 8.74958}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'CB2 2QQ', 'city': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'inVentiv Health Clinical', 'class': 'OTHER'}, {'name': 'PharmaNet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}