Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-26 @ 7:31 AM
Study NCT ID:
NCT02598466
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2015-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patterns of change in patient assessments of physical function with scores of the Health Assessment Questionnaire (HAQ) among users of SC Abatacept for RA since the commencement of a CUP in South Africa's private sector", 'timeFrame': 'Approximately 2 years'}], 'secondaryOutcomes': [{'measure': 'Demographic characteristics (age, gender, education and population group) of patients', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Reasons for discontinuation based on the reasons mentioned in Questionnaire', 'timeFrame': 'Approximately 2 years', 'description': 'Reasons for discontinuation: defined as common responses given for stopping treatment and include death, adverse event, lack of efficacy, lost to follow-up, withdrawal of consent, or other reasons'}, {'measure': 'Reasons for skipping treatment based on the reasons mentioned in Questionnaire', 'timeFrame': 'Approximately 2 years', 'description': 'Reasons for skipping treatment: defined as explanations given for inability to adhere to the recommended treatment regime and include fear of side effects, lack of access (too far) to medicine, inconvenient to use, too busy or forgetting, or other reasons'}, {'measure': 'Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores', 'timeFrame': 'Approximately 2 years'}, {'measure': 'Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events', 'timeFrame': 'Approximately 2 years', 'description': 'Adverse events: defined as any untoward medical event in a patient whether related or unrelated to SC abatacept and may include any sign (laboratory finding), symptom, or disease'}]}, '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': 'Research question: what are the patterns of patient-reported changes in physical function among adult patients using SC abatacept with moderate to severe RA since commencement of the compassionate use program (CUP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. Only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the CUP'}, 'identificationModule': {'nctId': 'NCT02598466', 'briefTitle': 'Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa', 'orgStudyIdInfo': {'id': 'IM101-572'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abatacept', 'interventionNames': ['Drug: Abatacept']}], 'interventions': [{'name': 'Abatacept', 'type': 'DRUG', 'armGroupLabels': ['Abatacept']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hexor, South Africa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}