Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-18 @ 6:45 PM
Study NCT ID:
NCT03457792
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2018-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Abatacept in Participants That Only Recently Started to Develop 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients continuing with abatacept treatment', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Anti-citrullinated protein antibody (ACPA) titer', 'timeFrame': 'At baseline'}, {'measure': 'Concomitant treatment given with abatacept as determined by the investigator', 'timeFrame': 'Up to 12 months'}, {'measure': 'Dosage of abatacept as determined by the investigator', 'timeFrame': 'Up to 12 months'}, {'measure': 'Frequency of administration of abatacept', 'timeFrame': 'Up to 12 months'}, {'measure': 'Reason for abatacept treatment initiation as determined by the investigator', 'timeFrame': 'At baseline'}, {'measure': 'Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Socio-demographics of participants as determined by the investigator', 'timeFrame': 'At baseline'}, {'measure': 'Disease history of participants as determined by the investigator', 'timeFrame': 'At baseline'}, {'measure': 'Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Simplified Disease Activity Score (based on 28 joints) (DAS28)', 'timeFrame': 'Up to 12 months', 'description': 'DAS28: Swollen joint count \\[SJC\\], tender joint count \\[TJC\\], C-reactive protein \\[CRP\\], erythrocyte sedimentation rate \\[ESR\\]'}, {'measure': 'Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of patients who achieve the first remission state, DAS28 < 2.6', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of Adverse Events (AE)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of Serious Adverse Events (SAE)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Existence or the absence of radiographic erosions as determined by the investigator by imaging technique', 'timeFrame': 'At baseline'}, {'measure': 'Existence or the absence of radiographic erosions as determined by the investigator by imaging technique', 'timeFrame': 'Up to 12 months'}, {'measure': 'Rheumatoid factor (RF)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Patient global assessment (PGA)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Evaluator global assessment (EGA)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Clinical disease activity index (CDAI)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Simple disease activity index (SDAI)', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': 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/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA\n* Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)\n\nExclusion Criteria:\n\n* Participants who are currently included in any interventional clinical trial in RA\n\nOther protocol defined inclusion/exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT03457792', 'acronym': 'ASCEND', 'briefTitle': 'A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'IM101-679'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abatacept for Rheumatoid Arthritis (RA)', 'description': 'Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79095', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}