Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-05 @ 11:54 AM
Study NCT ID:
NCT03793660
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2018-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biologic National Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013166', 'term': 'Spondylitis'}], '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'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D013122', 'term': 'Spinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2018-12-29', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessment of biotherapy - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy', 'timeFrame': 'Up to two years of follow-up', 'description': 'Incidence of Treatment-Emergent Adverse Events \\[Safety and Tolerability\\] : occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy'}], 'secondaryOutcomes': [{'measure': 'Assessment of Rheumatoid Arthritis Activity', 'timeFrame': 'At baseline and at two years follow-up', 'description': 'Number of patients with disease Activity Score (DAS) \\< 2.6'}, {'measure': 'Health Assessment Questionnaire', 'timeFrame': 'At baseline', 'description': 'HAQ assessment for Rheumatoid Arthritis patients (range score 0-3)'}, {'measure': 'Assessment of Spondylitis Fonctional Activity', 'timeFrame': 'At baseline and at two years follow-up', 'description': 'Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10)'}, {'measure': 'Assessment of Spondylitis Disease Activity', 'timeFrame': 'At baseline and at two years follow-up', 'description': 'Bath Ankylosing Spondylitis Disease Activity Index measurement (BASDAI) : (range score 0-10)'}, {'measure': 'Assessment of Spondylitis Activity', 'timeFrame': 'At baseline and at two years follow-up', 'description': 'Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) \\< 2.1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biologic', 'Safety', 'LITAR', 'DACIMA', 'Tunisia'], 'conditions': ['Arthritis, Rheumatoid', 'Spondylitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.facebook.com/groups/1611044669000801/about/', 'label': 'Social Media Group of the Project'}]}, 'descriptionModule': {'briefSummary': 'BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists', 'detailedDescription': 'BINAR is a Tunisian, descriptive, non-interventional, multicenter and prospective clinical study performed in rheumatology consultations, of both public and liberal sectors. Eligible patients are recruited by successive inclusions until the end of the recruitment period, set at one year. A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project and a Data Review Committee supervises the management of the data and carries out all the missions of audit and control of validity of the collected data, as well as the planning of statistical analysis.\n\nCollected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with biologic for rheumatoid arthritis or spondylitis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient followed for rheumatoid arthritis according to ACR EULAR criteria or spondylitis including all disorders (axial, peripheral, enthesitis).\n* Patient on biological treatment at the time of inclusion\n* First biological treatment initiated ≤ 2 years\n* Informed consent, read and signed\n\nExclusion Criteria:\n\n* Evolutionary neoplasia at the time of inclusion\n* Other associated systemic diseases, except Sjögren's Syndrome\n* Consent not obtained\n* Pregnant or lactating woman"}, 'identificationModule': {'nctId': 'NCT03793660', 'acronym': 'BINAR', 'briefTitle': 'Biologic National Registry', 'organization': {'class': 'OTHER', 'fullName': 'Dacima Consulting'}, 'officialTitle': 'Safety and Efficacy of Biotherapy in Rheumatoid Aarthritis and Spondyloarthritis. A Clinical Multicentric Study: Biologic National Registry (BINAR)', 'orgStudyIdInfo': {'id': 'DAC-004-LITAR'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ben Arous', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Habib Thameur', 'geoPoint': {'lat': 36.75452, 'lon': 10.22167}}, {'city': 'Ben Arous', 'country': 'Tunisia', 'facility': 'Rheumatology Department - HMPIT', 'geoPoint': {'lat': 36.75452, 'lon': 10.22167}}, {'city': 'Mahdia', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Tahar Sfar', 'geoPoint': {'lat': 35.50472, 'lon': 11.06222}}, {'city': 'Manouba', 'country': 'Tunisia', 'facility': "Rheumatology Department - Institut Mohamed Kassab d'Orthopédie", 'geoPoint': {'lat': 36.81006, 'lon': 10.09557}}, {'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Fattouma Bourguiba', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'city': 'Sfax', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Hédi Chaker', 'geoPoint': {'lat': 34.74056, 'lon': 10.76028}}, {'city': 'Sousse', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Farhat Hached', 'geoPoint': {'lat': 35.82539, 'lon': 10.63699}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Charles Nicolle', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Rheumatology Department - La Rabta', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Rheumatology Department - Mongi Slim', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Samir Kochbati, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'LITAR : Ligue Tunisienne Anti Rhumatismale'}, {'name': 'Kawther Ben Abdelghani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LITAR : Ligue Tunisienne Anti Rhumatismale'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dacima Consulting', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue Tunisienne Anti Rhumatismale', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}